Does Sleeping With Peanut Ball Help Position Baby

• Study Protocol
• Open Access
• Published: 04 Oct 2018

Using a peanut ball during labour versus not using a peanut ball during labour for women using an epidural: study protocol for a randomised controlled pilot study

• David Campbell²,
• Biing Yin^three,
• Wafa Al Omariⁱⁱ,
• Robin Burr^two,
• Heather Reilly^iv &
• Kenny Lawson⁵

Pilot and Feasibility Studies book 4, Commodity number:156 (2018) Cite this commodity

• 15k Accesses

• 1 Citations

• 2 Altmetric

• Metrics details

Abstract

Groundwork

The peanut ball has only been recently used as a support for women labouring with epidurals. The peanut ball is shaped like a peanut and fits snugly between the woman's legs and then that both legs are maintained as opening the pelvic outlet to increase the progress of labour and facilitate descent of the fetal caput. Using position changes during labour to enhance widening of the pelvic outlet tin can be benign but a woman who has an epidural is limited in the number of positions she can adopt. No randomised controlled trial has been implemented in Commonwealth of australia to plant the effectiveness of a peanut ball specifically for women using epidurals during labour, and this project addresses this gap. The main aim of this pilot study is to assess the feasibility and practicality of conducting and replicating this trial to a definitive randomised controlled trial (RCT).

Methods

A minimum number of l women (25 in each trial arm), who are using an epidural in labour at two hospitals in NSW over a one-yr period, will be recruited and randomly allocated into a grouping that uses the peanut brawl or into a grouping that does not utilize the peanut brawl. Main study objectives include assessing the proportion of women willing to exist randomised, retention/attrition rates, and with associated reasons. Data volition be collected on key clinical outcomes (natural nascency rate, length of stay) with means and variances estimated between trial artillery. This will inform the appropriate powering of a time to come definitive RCT. Secondary study objectives will include investigating the completion and acceptability of wellness and satisfaction surveys and assess the feasibility of conducting an economical evaluation alongside a hereafter trial.

Discussion

This is a two-armed randomised controlled pilot trial. Outcomes from this airplane pilot will inform a larger trial at a 3rd hospital.

Trial registration

Australian New Zealand Clinical Trials Registry, ACTRN12618000662268

Peer Review reports

Background

Epidurals have been associated with higher interventions during labour, including a higher incidence of instrumental births [1,ii,iii] particularly in women having a baby for the first time [4]. Vacuum births have more than than doubled in women experiencing epidurals [ane]. The National Institute for Health and Intendance Excellence Guidelines [v] states that in that location is no evidence pertaining to using a birth ball (the peanut ball falls into the category of a nascency ball) during labour, and this projection addresses this gap. This guideline [5] recommends that women should exist encouraged to motion and prefer whatever position she finds comfy in labour. In fact, at that place is no prove in Commonwealth of australia for using a peanut ball specifically for women using epidurals during labour.

The peanut brawl is thought to raise the progress of labour by optimally positioning the fetus in relation to the pelvis [six]. There are multiple benefits associated with maternal position changes, including increased maternal-fetal circulation, decreased pain, improved quality of uterine contractions, facilitation of fetal descent and decreased length of labour [7]. Apart from the physiological benefits of birth, other benefits include less risk of postpartum haemorrhage [eight], improved maternal–infant bonding [9], less psychological morbidity postnatally [10], increased rates of successful breastfeeding [9, 11] and improved maternal satisfaction [12]. The woman is as well able to independently care for her baby following the birth, whereas women having a caesarean may require more assistance with feeding and general care of the baby. Therefore, widening the pelvic outlet is one way of supporting natural progression of birth.

Three randomised command trials have been implemented in the United states on the utilise of a peanut ball during labour [13,14,fifteen]. Of the three randomised control trials in the USA, ane of the randomised control trials included women who were scheduled for elective consecration of labour and also who used an epidural for labour hurting. It was found that the length of fourth dimension in the first stage of labour was significantly shorter for primiparous (first time having a baby) women using the peanut ball when compared with multiparous (having already had one babe) women and the peanut brawl did not brand any difference for either group in the time spent pushing [14].

The other randomised control trial showed that women who used the peanut ball during labour had clinically significant lower caesarean section rates, lower instrumental births including forceps and vacuum births, and lower third and fourth degree perineal laceration rates. Even though the findings were clinically significant, they were not statistically pregnant. There was no difference in the length of stages of labour [15]. Ane of the randomised control trials showed that using the peanut ball was associated with a significantly lower incidence of caesarean surgery (OR = 0.41, p = .04) and is potentially a successful intervention to help progress labour and support vaginal birth for women labouring with an epidural anaesthesia. A modest group of nonrandomized labouring women with an epidural who used a peanut ball (n = 30) were compared to those who did not (n = 22). Lengths of first and second stages of labour were recorded. Results demonstrated a 46-min reduction in first-stage labour and an eleven-min reduction in 2nd-stage labour with women who used the peanut ball [13].

The main aim of this airplane pilot study is to assess the feasibility and practicality of conducting and replicating this trial to a definitive randomised controlled trial (RCT) in terms of the rate of willingness to be randomised, retention or attrition rate, staying in the allocated group and reasons for ceasing to use the peanut ball. Data will also be collected on the likely main and secondary outcome measures to ensure appropriate powering of the future definitive RCT and the minimum clinically important differences between the command and intervention groups. The secondary objectives will investigate completion and acceptability of the wellness and satisfaction surveys by women who utilise the peanut brawl and all women about their general level of wellness. Descriptive statistics volition be analysed to show fundamental clinical outcomes and the Isle of mann-Whitney U and chi-foursquare analyses for differences betwixt the command and intervention groups that will demonstrate an effect size to summate the appropriate sample size for the definitive RCT. Analyses will be performed bullheaded to group allocation. The study will also include economic measures for costs and health-related quality of life to appraise the feasibility of conducting an economic evaluation in a future definitive trial.

In that location is a need to further investigate these outcomes in Australia every bit Australia'south practising midwives are a singled-out profession compared with obstetric nurses in the USA, and then the US results cannot be generalised to Australia. The numerous midwifery-led models of care in Australia [xvi] (as compared with those of the USA) means that midwives encompass autonomy in their work and promote not-pharmacological or alternative therapies that would impact on their practice if they propose the peanut brawl when working with women with epidurals in labour. Midwifery-led models of care have identified benefits for women and babies with no adverse effects in collaboration with obstetricians and other health professionals [16].

This study will provide show about the effect of using the peanut ball for women who take an epidural during labour and be the offset of its kind in Australia. It is envisaged that the results of this study will provide evidence for a larger randomised controlled trial in other hospitals in the Nepean and Blue Mountains Local Health District.

Methods/design

This pilot study volition be implemented at the Blueish Mountains Anzac District Memorial and Lithgow hospitals, on a group of low-risk women, over a one-yr fourth dimension catamenia to appraise whether there is sufficient evidence for justification for using the peanut ball in a larger randomised controlled study.

Ethics approval for this study was granted in April 2018 by the Nepean Blueish Mountains Local Health District Human Research Ideals commission (HREC/eighteen/Nepean/30) and reciprocal approval from Western Sydney University – REDI Reference: RH12693. The trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618000662268, (http://www.ANZCTR.org.au/ACTRN12618000662268.aspx) on the 24th of Apr at 11:38 am. The study protocol (version 3, March 21, 2018) (see Additional file 1 SPIRIT Protocol) has been designed in accordance with the SPIRIT guidelines (see Additional file two). Whatsoever change to the trial protocol will exist communicated to all investigators, reflected in changes to the trial registry and first approved via the ideals commission.

Setting, recruitment and informed consent

The trial intervention will be conducted in Sydney, Commonwealth of australia, at the Centre for Nursing and Midwifery Research, Nepean hospital, Western Sydney University. The major sites for this pilot study are the Blue Mountains Anzac District Memorial and Lithgow hospitals. Pregnant primiparous (having start infant) and multiparous (having subsequent babe) women who are labouring with an epidural at the Blue Mountains Anzac District Memorial and Lithgow hospitals will be included in the study.

The participants will be identified and approached and consented during labour if they accept an epidural.

The women who fit the inclusion criteria will be provided a participant information sheet and then asked to sign a participant consent by the midwife not involved in her intendance. One time the woman has consented to the project, she has the opportunity to withdraw from the project at any time throughout the class of the project, and non be penalised. The consent will exist placed in a research box in the birthing suite by the midwife so that the researcher will be able to recontact the woman to consummate an online survey if she used the peanut brawl.

Eligibility criteria

Women will be eligible to participate in the trial if they present the following:

• At least 36 weeks of gestation with a live fetus

• Cephalic (head–downwards presentation)

Women will be ineligible to participate if they develop moderate to severe pre-eclampsia, or experience astringent essential hypertension, and if they are beingness treated for insulin-dependent diabetes (gestational or pre-pregnant). Women will also exist excluded if the fetal center rate trace is abnormal or suspicious or if they experience an intra-uterine expiry.

Randomisation and allocation concealment

Practitioners and participants will know the resource allotment grouping for the women, equally the woman will either apply the peanut ball or not employ the peanut ball, so they volition not exist blinded. A computerised, net-based central randomisation service (sealedenvelope.com) volition exist used to provide randomisation and resource allotment concealment. The research assistant and other investigators performing information collection, entry and analysis volition be blind to group allocation. The women will be randomly assigned to either the command or intervention group by the random allocation selection process that volition involve sealed opaque envelopes that only the midwife opens once the woman consents to exist involved in the pilot report. If the adult female is assigned to the intervention group, she would participate in using the peanut birthing ball, and if she is assigned to the command group, she would not use the peanut birthing ball.

Handling schedule

This study uses the same model (see Fig. 1) equally the previously same 3 randomised command trials [13,fourteen,fifteen] in the Usa, although Evans and Cremering (2016) simply included women having their first babies and Roth et al. (2016) only included women having an elective induction (not spontaneously labouring).

Fig. 1

Participant menses peanut ball versus no peanut brawl airplane pilot randomised controlled trial.

Full size image

Peanut brawl

Women in this grouping will apply the peanut ball during labour. The peanut brawl is latex free and burst resistant. Ideally, the woman should commence using the peanut ball post-obit insertion of the epidural, when the epidural has taken effect, so that the woman is comfortable and pain-gratuitous. Information technology is of import to change the woman'due south position if she is using the peanut brawl during labour with an epidural every 30 min. There are four main positions to be used with the woman having an epidural when she is using the peanut ball.

• The side lying position is when the woman is lying on her side, and the peanut ball is wedged between her legs. The top leg lays on the top of the peanut ball curve, and the bottom leg is bent underneath the peanut ball curve. The head of the bed is elevated as much every bit possible to ensure that the adult female is comfortable—see image.

  

• The tuck position is besides a side lying position, and the legs are pulled upwardly towards the woman's head and the ball is brought forward towards the woman'southward chest so that the adult female can hug the ball with her arms. The caput of the bed should also exist elevated as much as possible to ensure that the adult female is comfortable. This position tin likewise exist used for pushing—run into image.

  

• The semi sitting position is when the woman is sitting semi recumbent, and the height leg rests over the peanut brawl over the natural curve and the bottom leg is aptitude and rests nether the ball—run into image.

  

• The Taylor position is similar to the semi sitting position, although the legs clasp the ball and the bottom leg moves up a bit higher towards the woman'southward caput—see image.

  

Not using peanut ball

The group of women non using the peanut brawl volition be provided the usual care during labour if using an epidural for pain relief.

Objectives

The study will have a number of pre-specified measures to accost the following objectives, and these measures are detailed for each objective. The primary objectives (run across Table ane) relate to progressing the trial to a definitive RCT trial. The secondary objectives (see Table 1) will item the completion of the survey tools and drove of other variables that are key clinical outcomes when assessing the differences [17] betwixt women using the peanut brawl and the group who does non.

Table 1 Participant timeline of assessments and interventions

Total size table

Primary objectives

The master objectives of the trial include the following:

1. one.

   To make up one's mind how many women are willing to be randomised into either the control or intervention group

2. 2.

   To estimate recruitment and attrition charge per unit of women into the study

3. 3.

   To estimate the number of women staying in the allocated grouping

4. 4.

   To determine why women stopped using the peanut brawl

5. v.

   To appraise likely primary and secondary outcome measures to inform sampling size and powering of the definitive RCT

Secondary objectives

The secondary objectives include the following:

1. ane.

   To investigate completion of the health and satisfaction surveys

2. two.

   To assess the feasibility of conducting an economic evaluation aslope a futurity definitive trial

3. 3.

   To mensurate primal clinical outcomes and differences between the command and intervention group (see Table 1)

Tabular array 1 outlines the participant timeline of assessments and interventions.

Measures used to achieve objectives

Primary objectives

1. one.

   Willingness of women to be randomised into the control or intervention grouping

   The measure out used to appraise this objective will exist assessed by the midwife in the birthing unit, and one time the woman has an epidural in situ, the woman will then be consented by the midwife. The midwife will so access the sealed opaque envelopes that allocate the woman to the group using the peanut brawl or the group receiving standard care and non using the peanut ball (this has been generated by the computer software: sealedenvelope.com). The midwife will have no previous knowledge of which grouping the woman volition be allocated to until the envelope is opened (allocation concealment). If the woman has been allocated to the group not using the peanut ball and she decides she wants to apply the peanut brawl, the woman's reasons for using the peanut ball will be noted and the midwife will notate this in the Peanut Brawl Inquiry Notebook that accompanies the boxes for information and consent and the allocation box in the birthing suite. The Coordinating Investigator volition liaise and visit contacts at both sites for this information.

2. 2.

   Estimation of recruitment and attrition rate

   Acceptability of the recruitment methods volition be assessed including any agin events recorded whilst using the peanut brawl during labour (these details will exist accessed via the Electronic Medical Tape or adult female'south progress notes during labour by the coordinating investigator). The chief method of recruitment of the women volition be midwives working in the birthing unit of measurement, identifying and budgeted the woman, as they have been previously educated about the research projection by pedagogy sessions and an instruction packet has also been written for the midwives about using the peanut ball for the research project provided by the coordinating investigator. Sample size analysis should be adequate to estimate the recruitment rate [18]. Modifications may be made to the protocol for the total trial based on recruitment rates.

3. 3.

   Estimation of women staying in allocated group

   Midwives will record in the Peanut Ball Research Notebook in the birthing unit of measurement if the woman changes her mind if she is allocated to the control or intervention group and decides to change to the other grouping other than the grouping she has been allocated. It is important to achieve an "intention to treat analysis" and that participants are analysed according to the grouping they are originally allocated [19].

4. iv.

   To determine why women stopped using the peanut ball

   The Analogous Investigator volition access the Electronic Medical Record to appraise why the adult female stopped using the peanut ball. Information technology is important to achieve an "intention to treat analysis" to determine whether or not they adhered to or accepted the intervention. The importance of reporting of numbers and the reasons why participants were lost to follow up is necessary to assess the extent to what the intention to treat may lead to and provide an underestimate of the efficacy of the intervention under ideal circumstances [19].

5. 5.

   To assess likely primary and secondary outcome measures to inform sampling size and powering of the definitive RCT

   The main purpose of this pilot study is to assess the feasibility of conducting a total definitive trial and non to generate statistically significant results. Notwithstanding, a secondary aim is to inform the sample size calculation to design a full definitive trial. This requires an estimate of a clinically meaningful effect size and variance that can be entered into a sample size calculation. The central master clinical issue is the rate of vaginal births, and the central secondary outcome is the length of labour. For this pilot study, a decision was taken to opt for 50 pregnant women (25 in each trial arm) to inform this process. Indeed, a previous pilot report that investigated the utilise of the peanut ball with similar aims determined that this sample size may really be sufficient to demonstrate statistically significant findings [13]. Therefore, given the high feasibility of recruiting these numbers of women at the written report sites, a decision was then made to aim for fifty pregnant women in total (equally a minimum), and so opt for a comprehensive airplane pilot trial to ensure the airplane pilot tin confidently examination feasibility and also inform the powering of a future definitive trial.

Secondary objectives

1. one.

   To investigate completion of the health and satisfaction surveys

   Health and satisfaction surveys

   1. a.

      The Health Questionnaire (EQ-5D) will provide important general concrete and mental wellness data nearly mobility, self-care, usual activities, (for example, work, report, housework, family or leisure activities), pain, discomfort, anxiety, and low. EQ-5D is a standardised measure of health status adult past the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisement. The EuroQol Grouping is a network of international multidisciplinary researchers devoted to the measurement of health condition [20]. The Health Questionnaire will likewise request a single score most level of health experienced on that particular day. The offset v questions are measured on a Likert calibration, and the last question about perception of health asks the respondent to answer on a scale from 0 to 100 with 0 meaning the worst health they can imagine and 100 significant the best wellness they can imagine. It is cognitively undemanding, taking only a few minutes to consummate. The survey is applicable to a wide range of wellness conditions and treatments; it provides a unproblematic descriptive profile and a single index value for wellness condition that tin can be used in the clinical and economic evaluation of wellness care every bit well equally in population wellness surveys. The EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics and in face-to-face interviews [xx].

   2. b.

      The survey assessing satisfaction levels obtains information in thirteen questions well-nigh using the peanut ball in Likert scale responses, yep/no answers and costless text responses and takes approximately v min to complete. The survey will provide a snapshot nigh the adult female'south experience and enquire most the benefits of using the peanut ball, subsequent apply of the peanut ball, whether the woman would recommend using the peanut ball to other women and reasons why, discomfort, specific positions used with the peanut brawl, experiencing feelings of empowerment and result on length of labour and demographic details. The survey was developed in alignment with the results of the previous randomised controlled trials [13,xiv,xv] and as this research only focuses on quantitative information, it was thought that it was beneficial to obtain some data from women nearly the comfort, perception and satisfaction near using the peanut ball every bit complementary evidence to the pilot randomised controlled trial. Face validity has been verified by this survey being reviewed and approved by an ideals commission of skillful health research professionals in a local wellness district in NSW, and the survey will exist further validated in this airplane pilot study by comparing responses from both sites by using construct validity and establishing advisable sample size.

   Both surveys will be distributed to the respondents from an electronic platform—Qualtrics [21] platform—and have been electronically tested to appraise the functionality prior to distribution of the online survey. Each survey will be distributed to the participant's e-mail and de-identified in the figurer database. All surveys will be analysed, including those not completed. All of the data collected in this closed survey volition be stored in a password-protected computer and will only be accessible past the researchers.

2. 2.

   To assess the feasibility of conducting an economic evaluation alongside a time to come definitive trial

   The feasibility of collecting data required for an economic evaluation volition be tested. For this pilot, we will collect information on wellness service usage betwixt trial arms, including staff time, medications, procedures and length of stay in hospital. The inclusion of the EQ5D5L will assess the feasibility of incorporating an economic measure of HRQoL, where responses volition be converted into 'health utilities'.

3. three.

   To measure fundamental clinical outcomes and differences between the control and intervention group

   Details nearly other nascence outcomes volition also exist collected to decide the baby's status, perineal damage, other methods of pain relief used, position of mother and babe during labour, blood loss, cervical dilatation at time of insertion of epidural and bear witness of augmentation and/or induction of labour.

Statistical analysis

Quantitative data

In terms of the women's willingness of being randomised into the control or intervention grouping and assessment of recruitment and attrition rates and staying in the allocated groups, the Coordinating Investigator volition access this information from the Peanut Ball Research Notebook and appraise the sample size. This information will be estimated every bit accurately as possible from the critical parameters nosotros wish to approximate [19, 22] that includes the minimum important differences when comparing the ways of continuous outcomes and chiselled outcomes between the intervention and control groups. The differences between the vaginal birth rate (cess of likely primary outcome for definitive RCT) and the length of labour (cess of likely secondary effect for definitive RCT) will be analysed. Demographics volition be reported using descriptive statistics. The Coordinating Investigator will also access women lost to follow upward and if women stopped using the peanut ball from the Electronic Medical Tape.

The purpose of the airplane pilot is to assess the feasibility of the component elements together to inform a definitive trial. The airplane pilot and sample size of l is not intended to be powered to conduct meaningful statistical tests [nineteen]. Nonetheless, and for exposition purposes, standard tests volition exist conducted and reported. Online survey results will provide complementary data from the woman's perspective of using the peanut ball during labour and health and quality of life.

Qualitative data

The text responses from the online survey about the woman'south satisfaction about using the peanut ball volition exist analysed by thematic analysis. Thematic assay is an iterative and inductive procedure which will involve researchers reading and identifying and labeling codes in the data, and developing themes and subthemes.

Discussion

The peanut ball is a non-pharmacological method of pain relief that may exist used by women using epidurals in labour, and preliminary randomised controlled trials in the USA take shown clinically and statistically significant findings. Currently, peanut balls are being used by women during labour, in hospitals in Australia; however, there is no existing evidence that the peanut brawl makes a difference for women, either as a birthing ball or whilst using an epidural. It is of import to fully investigate the potential benefits of using the peanut ball in Australia, particularly when nosotros are now working with increased rates of caesarean sections [23].

The web-based survey about the woman's general health will provide general concrete and mental health data about mobility, self-care, usual activities, pain, discomfort, anxiety and low. We would expect that this cohort of pregnant women with low-risk pregnancies will provide a effect of a mostly healthy population. The spider web-based survey near using the peanut ball will provide a snapshot of information about the woman's level of satisfaction, positions she used, her perception well-nigh influencing the length of labour, level of empowerment and whether she would recommend the peanut brawl to other women using epidurals during labour. Demographics volition also be collected. Expected results in the overall context of the study would evidence that the peanut brawl has benefits for women using epidurals in labour, not just in her positive perception and feeling of empowerment but also increasing her comfort.

This study will be the beginning to investigate the airplane pilot effect of the peanut ball for women using epidurals in labour in a low-take a chance maternity model of care in Australia. It is expected that the hateful clinical and health service outcomes will improve in the peanut brawl arm. If the results point to reject using the peanut ball and no benefits are found, information technology is expected that midwives will continue to advise using the peanut ball to increment comfort and empowerment for women using epidurals in labour. The airplane pilot trial volition inform the evolution of a fully powered definitive trial to assess the clinical meaningful and statistically significant outcomes, including an economic evaluation to assess cost effectiveness.

Trial condition

Recruitment has not yet commenced.

Abbreviations

RCT:

Randomised controlled trial

References

1. Anim-Somuah K, Smyth RM, Jones L. Epidural versus non-epidural or no analgesia in labour. Cochrane Database Syst Rev. 2011;CD000331:12.

   Google Scholar

2. Leighton, B. L., & Halpern, Southward. H. The effects of epidural analgesia on labor, maternal, and neonatal outcomes: a systematic review. Am J Obstet Gynecol. 2002;186 Suppl 5:69–77. http://dxdoi.org/10.1016/S0002-9378(02)70182-8 Accessed viii Feb 2018.

   CAS  PubMed  Google Scholar

3. Lieberman E, O'Donoghue C. Unintended furnishings of epidural analgesia during labor: a systematic review. Am J Obstet Gynecol. 2002;186(Suppl 5):31–68.

   Commodity  Google Scholar

4. Comparative Obstetric Mobile Epidural Trial Study Group. Outcome of depression-dose mobile versus traditional epidural techniques on fashion of delivery: a randomised controlled trial. Lancet. 2001;358(9275):xix–23.

   Article  Google Scholar

5. The National Plant for Wellness and Care Excellence Guidelines. 2017 https://www.nice.org.britain/guidance/cg190/bear witness/total-guideline-pdf-248734770 Accessed 8 February 2018.

6. Johnston J. Birth balls. Midwifery Today Int Midwife. 1997;43:59–67.

   Google Scholar

7. Zwelling Due east. Overcoming the challenges: maternal movement and positioning to facilitate labor progress. MCN Am J Matern Child Nurs. 2010;35(2):72–8.

   Article  Google Scholar

8. Davis D, Baddock S, Pairman S, et al. Risk of severe postpartum hemorrhage in low-risk childbearing women in New Zealand: exploring the effect of place of nascence and comparing third stage direction of labor. Birth. 2012;39:98–105.

   Article  Google Scholar

9. Moore, E.R., Anderson, G.C. & Bergman, N. Early pare-to-skin contact for mothers and their good for you newborn infants (no. three). Cochrane Database Syst Rev CD003519. 2007. doi:https://doi.org/10.1002/14651858. Accessed eight Feb 2018.

10. Michels A, Kruske S, Thompson R. Women's postnatal psychological functioning: the role of satisfaction with intrapartum care and the birth experience. J Reprod Infant Psychol. 2013;31:172–82.

    Article  Google Scholar

11. Brown A, Hashemite kingdom of jordan S. Impact of birth complications on breastfeeding elapsing: an internet survey. J Adv Nurs. 2013;69:828–39.

    Article  Google Scholar

12. Leap N, Sandall J, Buckland Southward, Huber U. Journey to confidence: women′s experiences of pain in labour and relational continuity of care. J Midwifery Womens Health. 2010;55:234–42.

    Commodity  Google Scholar

13. Tussey CM, Botsios E, Gerkin RD, Kelly LA, Gamez J, Mensik J. Reducing length of labor and caesarean surgery rate using a peanut ball for women labouring with an epidural. J Perinat Educ. 2015;24(i):16–24.

    Article  Google Scholar

14. Roth C, Dent SA, Parfitt SE, Hering SL, Bay RC. Use of the peanut ball during labor. Am J Matern Kid Nurs. 2016;41(iii):140–six.

    Article  Google Scholar

15. Evans SJ, Cremering MM. Apply of peanut labor brawl for pelvic positioning for nulliparous women post-obit epidural anesthesia. J Obstet Gynecol Neonatal Nurs. 2016;45(Suppl 3S):S47.

    Article  Google Scholar

16. Homer, C. Models of maternity intendance: evidence for midwifery continuity of care. Med J Aust 2016; 205(8):370–374. doi: https://doi.org/10.5694/mja16.00844. Accessed 8 Feb 2018.

    Article  Google Scholar

17. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopwell Due south, Thabane L, Lancaster GA. Espoused 2010 argument: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239.

    Article  Google Scholar

18. Teare Dr., Dimairo M, Shephard Due north, Hayman A, Whitehead A, Walters SJ. Sample size requirements to gauge key pattern parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014;15(264):ane–13 http://world wide web.trialsjournal.com/content/xv/i/264.

    Google Scholar

19. Kirkwood BR, Sterne JAC. Essential medical statistics. Oxford: Blackwell Science; 2003.

    Google Scholar

20. The EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208.

    Article  Google Scholar

21. Qualtrics. 2005; Copyright year: 2018, Provo, Utah U.s.a.. https://www.qualtrics.com

22. Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008;31:180–91. https://doi.org/10.1002/nur.20247.

    Article  PubMed  Google Scholar

23. McLachlan H, Forster DA, Davey MA, Farrell T, Gilt 50, Biro MA, Albers L, Flood M, Oats J, Waldenstromh U. Effects of continuity of care by a primary midwife (caseload midwifery) on caesarean department rates in women of low obstetric chance: the Creation randomised controlled trial. BJOG. 2012. https://doi.org/10.1111/j.1471-0528.2012.03446.x.

    CAS  Commodity  Google Scholar

Download references

Acknowledgements

Heather Borradale has provided significant input into designing the education package for the study. Deborah Gaynor and Madeleine Simpson will provide significant assistance in the trial recruitment. Justine Elliott has provided input into the study pattern.

Funding

Partnership grant awarding has been submitted and approved betwixt Nepean Blue Mountains Local Health Commune and Western Sydney Academy for the value of $ten,000.

Author information

Affiliations

1. School of Nursing and Midwifery Heart for Nursing and Midwifery Research, Nepean Hospital, 1st level Court Building, Derby St, Kingswood, NSW, 2340, Australia

   Virginia Stulz

2. Nepean Infirmary, Derby St, Kingswood, NSW, 2340, Australia

   David Campbell, Wafa Al Omari & Robin Burr

3. Lithgow Hospital, Corner Col Drewe Bulldoze and Keen Western Highway, Lithgow, NSW, 2790, Australia

   Biing Yin

4. Centre for Nursing and Midwifery Research, Nepean Hospital, 1st level Court Building, Derby St, Kingswood, NSW, 2340, Commonwealth of australia

   Heather Reilly

5. Translational Health Inquiry Constitute, Edifice three, David Pilgrim Avenue, Campbelltown, NSW, 2560, Australia

   Kenny Lawson

Contributions

VS, KL, DC, WA, BY, RB and HR contributed to the conceptualisation and design of the study. VS and KL took the pb on drafting the study protocol, and all authors provided critical feedback. KL provided statistical advice on cost evaluations. All authors approved the final manuscript.

Respective author

Correspondence to Virginia Stulz.

Ideals declarations

Ethics blessing and consent to participate

Ethics approval for this written report was granted in April 2018 by the Nepean Bluish Mountains Local Health Commune HREC/18/Nepean/thirty and the Western Sydney University Man Inquiry Ethics Committee Reciprocal Approval REDI Reference: RH12693. Written consent for participation will be obtained prior to randomisation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher'southward Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Additional files

Rights and permissions

Open up Access This commodity is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/four.0/), which permits unrestricted utilise, distribution, and reproduction in any medium, provided you requite advisable credit to the original author(s) and the source, provide a link to the Artistic Commons license, and indicate if changes were fabricated. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Reprints and Permissions

About this article

Cite this article

Stulz, V., Campbell, D., Yin, B. et al. Using a peanut brawl during labour versus non using a peanut ball during labour for women using an epidural: study protocol for a randomised controlled pilot report. Pilot Feasibility Stud 4, 156 (2018). https://doi.org/10.1186/s40814-018-0346-nine

Download commendation

• Received: 25 April 2018

• Accepted: 17 September 2018

• Published: 04 October 2018

• DOI : https://doi.org/10.1186/s40814-018-0346-nine

Keywords

• Peanut ball
• Labour
• Epidural

burkettselmerry1953.blogspot.com

Source: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0346-9

Share this post