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Effectivness of cooling gel pads and ice packs on perineal pain
By Shahin Navvabi, Zahra Abedian and Mary Steen-Greaves
This article reports the findings of a randomized controlled trial undertaken at the Hazrat Ommolbanin University Maternity Hospital in Mashhad, Iran, which investigated the effectiveness of localized cooling treatments to alleviate perineal trauma. From October 2005 to February 2006, 121 primiparous women who were at term and had an episiotomy were randomly recruited to one of three treatment groups (Group 1 – no localized cooling; Group 2 – Ice pack; Group 3 – cooling gel pad). The intensity of pain, wound healing and women’s satisfaction levels were the main outcomes measured. The intensity of pain was measured by a Numeric Rating Scale (NRS) (1–10) and wound healing was evaluated by the REEDA scale within 4 hours of episiotomy repair; at days 1, 2, 5 and 10. The use of oral analgesia was measured at day 10. Women’s satisfaction levels with oral analgesia and localized cooling treatments were also assessed at day 10 by a NRS. There was evidence that localized cooling treatments are effective in alleviating perineal pain, which was in favour of the cooling gel pad group. A statistical significant difference was reported at 4 hours (P=0.003); day 2 (P=0.004); and at day 10 (P=0.044). At days 1 and 5 there was evidence of a reduction in the intensity of pain but this did not reach a statistical significant difference. A reduction in the use of oral analgesia was reported in favour of the cooling gel pad group (P<0.001). Women’s satisfaction levels with oral analgesia were similar within the three treatment groups but a higher level of satisfaction when assessing localized treatment was reported by the cooling gel pad group (P<0.001). Wound healing rates were also reported to be better in the cooling gel pad group when compared to the other two groups (P<0.001). Women’s views and treatments to alleviate perineal pain without any adverse affects on wound healing are important aspects of midwifery care. This trial has demonstrated evidence that localized cooling of the perineum reduces the intensity of pain. Women were more satisfied when applying cooling gel pads and this treatment appeared to assist in wound healing.
erineal pain following an episiotomy often has numerous negative consequences for many women and the associated pain can dominate the experience of early motherhood (Steen, 2001). It is important that there are treatments readily available to alleviate the associated pain and discomfort. It is also important that treatments will not have an adverse effect on healing and are acceptable to use by women. In Iran, the standard method of pain relief for perineal pain is oral analgesia, acetaminophen (paracetamol), and is given systemically. Localized cooling treatments are not commonly used. In 2005, midwifery researchers based in Mashhad Iran carried out a literature search on perineal pain relief methods and found articles describing and discussing the use of localized cooling treatments as a pain relief method for perineal trauma. This lead to contacting a midwifery researcher in the UK who had undertaken research and development work which involved the designing and laboratory testing of a maternity cooling gel pad (femepad) (Steen and Cooper, 1997; 1999) and investigating the effectiveness of this new treatment in two randomized controlled trials. (Steen et al, 2000; Steen and Marchant, 2001; 2007) This led to collaborative work and a further randomized controlled trial was undertaken to evaluate the effectiveness of two cooling treatments (ice pack and gel pad) and compare these with a no localized treatment regime (control) on intensity of perineal pain after episiotomy in primiparous women who gave birth at Hazrat Ommolbanin University Materity Hospital in Mashhad, Iran from October 2005 to February 2006.
The following hypothesis was tested: The use of a cooling gel pad is more effective at reducing intensity of perineal pain following a normal delivery aided by an episiotomy when compared with an ice pack or no localized treatment.
Ethical approval was given by the study hospital’s ethics committee and the hospital’s research governance recommendations were followed. An information leaflet about the study was distributed to women during pregnancy and further information was given following episiotomy repair by the researcher (SN). Participants’ informed consent was sought before being recruited.
Shahin Navvabi is Midwife and Researcher, Zahedan University of Medical Science Nursing and Midwifery, Mashhad Iran; Zahra Abedian is Supervisor, Mashhad University of Medical Science, Iran; Mary Steen-Greaves is Reader in Midwifery and Reproductive Health, Faculty of Health and Social Care, University of Chester Email: firstname.lastname@example.org
Participants had to meet the following inclusion criteria: n Iranian (Dewill Mashhad) nationality n Primparous n Age 16–35 years
BRITISH JOURNAL OF MIDWIFERY, NOVEMBER 2009, VOL 17, NO 11
Randomized n=121) Excluded n=763 Inclusion criteria not met n=500. The acronym REEDA is derived from five components that have been identified to be associated with the healing process.RESEARCH AND EDUCATION Assessed for eligibility 2 October 2005–2 February 2006. Outcome measures The intensity of pain. other reasons n=3 No treatment group n=40 Ice pack group n=40 Gel pad group n=41 Randomization Lost to follow-up n=4 Discontinued intervention day 2 n=2 day 10 n=2 Lost to follow-up n=5 Discontinued intervention day 2 n=3 day 10 n=2 Lost to follow-up n=2 Discontinued intervention day 5 n=2 Analysed n=36 Analysed n=35 Analysed n=39 Figure 1. All particpants gave birth in the lithotomy position and were sutured with chromic catgut (routine in Iranian hospitals). Each category is assessed and a number assigned for a total REEDA score ranging from 0–15. A descriptive scale known as the REEDA scale (Davidson. Comparison of mean score – intensity of perineal pain during 4 hours after episiotomy 726 . The higher scores indicate increased tissue trauma. Women received oral analgesia and the randomized localized treatment within 4 hours of episiotomy repair by researcher (SN). wound healing. then self-adminstered pain relief based on their individual needs at home. use of analgesia and women’s satisfaction levels were the main outcomes measured. was used.522 degrees of freedom=2 After analgesia use: K-W test: P=0. Total births during trial period n=1274) Vaginal births with episiotomy n=884) n n n n Occiput anterior presentation Singleton birth Birth weight (2500–4000 g) Have addresses and telephone number. NO 11 Control Ice pack gel pad Before analgesia use: ANOVA test: P=0. edema. which acknowledges the need for a standardized assessment tool independent of the severity of the perineal injury. discharge and approximation of skin edges. using direct measurement and observation. NOVEMBER 2009. graded 0–3 points. at days 1. 2. n n n n n 5 4 3 2 1 0 Term fetus (37–42 weeks gestation) Normal delivery Lives with a partner Ability to read and write (Farsi) at 5th primary level Mediolateral episiotomy Before analgesia After analgesia Primiparous women (n=121) who were at term and had an episiotomy were randomly recruited to one of three treatment groups: n Group 1 – No localized cooling n Group 2 – Ice pack n Group 3 – Cooling gel pad. Randomization was undertaken by a random number table. VOL 17. Exclusion criteria Women were excluded for any of the following reasons: n Woman with any medical disorders or obstetric complications n Fetal anomally n Stillbirth n Needing neonatal intensive care unit n Retained placenta n Smoking n Consumption of alcohol or continuous drugs n Rupture membranes >12 hours n Stretch or massage of perineum in pregnancy or during delivery stages n Use of lubricant during delivery n Second stage of delivery >120 minutes n Postpartum haemorrhage n Haematoma. These are: redness. 5 and 10. refused to participate n=250.003 degrees of freedom=2 Figure 2. This tool appears to be the first systematic attempt to evaluate postpartum healing. The use of oral analgesia (acetaminophen) was measured at BRITISH JOURNAL OF MIDWIFERY. 1974) measuring five components associated with the healing process. The intensity of pain was measured by a Numeric Rating Scale (NRS) (0–10) and wound healing was evaluated by the REEDA scale within 4 hours of episiotomy repair (baseline). Flow chart to demonstrate process of the trial. ecchymosis.
Steen and Marchant.91 SD Findings The flowchart (Figure 1) demonstrates the process women went through during the trial and shows the phases of a trial.13 2. therefore.17 1. The majority of women will sustain some degree of injury during childbirth and rates as high as 85–95% have been reported (Albers. urethra.001).57 1.94 3. Steen and Cooper.27 2.01 3. 2005).03 Mean SD Mean SD Mean SD Mean SD Mean SD Discussion Perineal trauma can involve injury to the labia.22 2.84 2. NOVEMBER 2009.10 7.34 2. clitoris.62 2. Compare mean (standard deviation) intensity perineal pain after episiotomy Test Day 1 P=0.08 0. In the UK. 2007). NO 11 pain (Moffatt et al. 1993.83 1. In the 1990s.33 12.61 1.8 1. It can occur spontaneously during a vaginal birth.12 2. 2005).001 Gel pad Icepack Control 8. 1998). Women were assessed for eligibility at the beginning of the trial and information is shown on the number of women recruited and then randomized to each of the three treatment groups. SD Table 2. VOL 17. be caused by trauma during an instrumental delivery or by a surgical incision (episiotomy). but especially for those women who have had an episiotomy performed. Satisfaction with analgesia Mean number of tablets (acetaminophen) in 3 groups during 10 days (K-W) Mean (SD) score satisfaction Mean oral analgesia (K-W) Mean (SD) score satisfaction Test P=0. Table 1. 1998.089 5.20 1.12 0.18 0. Low and Reed (2000) and Palastanga (1994). Sleep.001 P=0. 1990. some concerns as to whether an ice pack can delay healing were voiced (Walker. 2001). 1990 Sleep.50 1.80 1. however.08 3.004 Mean (ANOVA) Day 5 P=0.20 1.044).96 Mean (ANOVA) Day 2 P=0. 2005).RESEARCH AND EDUCATION day 10. Ice packs have been reported as a commonly used localized treatment to relieve perineal pain (Greenshields and Hulme. Women’s satisfaction levels with oral analgesia and localized cooling treatments were also assessed at day 10 by a NRS.13 9.50 Icepack 2.42 1. 2.004) and at day 10 (P=0. Mann-Whitney U. have discussed 727 . or an anti-inflammatory drug such as ibuprofen (brufen) (Sleep. Paracetamol is usually advised for mild to moderate perineal BRITISH JOURNAL OF MIDWIFERY. 2001). is vitally important for any woman who has sustained some form of injury. Analysis of variance (ANOVA) and exact tests were used with a SPSS software package. 2002).29 2. perineal muscles and anal sphincters (Royal College of Obstetricians and Gynaecologists (RCOG).17 1.74 1. A statistical significant difference was reported at 4 hours (P=0. vagina. 1990).39 3.2 Control 2. Jonckheere Trepstra. 2004) and is sometimes referred to as genital tract trauma (Steen.05 6. Women’s satisfaction levels with oral analgesia were similar within the three treatment groups but a higher level of satisfaction when assessing localized treatment was reported by the cooling gel pad group (P<0. 1989.001) (Table 3).429 3. 1990).07 3.003) (Figure 2).87 4.70 Control 4.89 2. Grundy. a combination of systemic and localized treatments are used for pain relief to meet individual women’s needs (Steen. However.26 1.001 Gel pad 3. as recommended by the CONSORT statement (Moher et al.30 1.55 1. 1990. Oral analgesia is the most common systemic method used while in hospital and is continued on the woman’s return to her own home (Steen and Marchant.36 2. there is evidence that an episiotomy is more painful when compared with perineal tears and can take longer to heal (McGuiness et al. they became a popular method to alleviate perineal trauma (Rhodes and Barger. Steen and Cooper.02 1. Alleviating perineal pain.50 2.70 1. Loss to follow-up and discontinuation of intervention encountered during the trial period are highlighted and the final numbers included in the analysis are shown.17 0. 1997).97 2. 1990.79 1. If a woman reports more severe pain then a combination of paracetamol and dextropoxephene (coproxomal) is sometimes offered.66 2.22 P=0.056 Mean (ANOVA) Total Gel pad Icepack 4. There was evidence that localized cooling treatments are effective at alleviating perineal pain which was in favour of the cooling gel pad group.11 3. 2007) Ice bags were originally applied to the rectal region to alleviate haemorrhoidal pain and with the increase in episiotomy rates in the 1970s and 1980s. A reduction in the usage of oral analgesia was reported in favour of the cooling gel pad group (P<0. Wound healing rates were also reported to be better in the cooling gel pad group when compared to the other two groups (P<0. Mean (standard deviation) REEDA score after episiotomy in 3 groups (Kruskal Wallis test) 4 Hours Day 1 Day 2 Day 5 Day 10 Test P=0.65 5.99 SD Data analysis Data were recorded on a coded questionnaire and analysed by descriptive and inferential statistical methods: chisquare. Steen.001 P=0.91 2.84 17.47 SD P=0.004 P=0.416 P=0.17 2.33 3.86 2. At days 1 and 5 there was evidence of a reduction in the intensity of pain but this did not reach a statistical significant difference (Table 1).85 2.001) (Table 2). day 2 (P=0. Kruskal Wallis (K-W).11 2. The application of ice packs to the perineum appears to give some short-term pain relief by numbing the superficial tissue surrounding the injury through its action on local nerve fibres (Hill.41 1.001 Table 3.83 1.
Limitations When undertaking any research there are always some limitations. swelling and bruising without any adverse effects on wound healing (Steen et al. therefore. Validated tools. NO 11 . 1977). 1997. there is always the possibility of the ‘hawthorne effect’. 2005). which is followed by a vasodilation. size and texture of the cooling treatments and a clear ‘no treatment’ group made informing the women unavoidable. women who had an episiotomy were offered systemic pain relief in the form of oral analgesia. swelling and bruising up to 2 weeks following birth with no adverse affects on healing. 2006). will increase circulation and promote healing. Nevertheless. Wound healing rates is also an important outcome measure (Steen. will need to be included in the next meta-analysis and updating of this review. NOVEMBER 2009. there is a possibility that the assessor may have become aware of some women’s treatment allocation if women left these visible when the assessments were performed. however. A recent Cochrane’s review assessed evidence from published and unpublished randomized and quasi-randomized trials (RCTs) that compared localized cooling treatment applied to the perineum with no treatment or other treatments applied to relieve pain related to perineal trauma sustained during childbirth (East et al. 1999). alleviating perineal trauma (APT Study) was undertaken in 1998–1999 and this provided further evidence that cooling maternity gel pads were effective at reducing pain. were used by an experienced researcher and women’s satisfaction with the treatment was sought. This review reported limited evidence of the effectiveness of localized cooling treatments on perineal pain but highlighted that women preferred cooling gel pads when compared with icepacks and no localized treatments. This trial was not included in the review results and was recorded as an ongoing study. It has also been reported that ice application will effectively lower skin temperature only but the low conductivity of underlying subcutaneous fat tissue will prevent any cooling of deeper tissue (McMasters. 2002. This trial. 2007) and will also need to be assessed in the next review. acetaminophen (paracetamol). It was impossible to blind the women as to what treatment they would be applying to their perineum. Nevertheless. Steen and Marchant. The evidence reported from this trial first confirms the evidence reported in the two randomized controlled trials undertaken in the UK already mentioned and second. has provided evidence to support the use of localized cooling treatments to alleviate perineal pain in Iranian maternity hospitals. which is a form of reactivity whereby subjects improve an aspect 728 BRITISH JOURNAL OF MIDWIFERY. VOL 17. Women’s opinions demonstrated a preference for using cooling gel pad when compared to standard regimes. ice packs have been reported to cause some women unnecessary distress and discomfort. A randomized controlled trial undertaken in 1993–1994 demonstrated evidence that cooling gel pads were effective at reducing perineal oedema and pain within the first 48 hours of birth. sharp corners and wet sensation make them unpleasant to use (Steen. The difference in shape. 2007). Women’s views demonstrated a high level of satisfaction when using the new cooling gel pads when compared to ice packs and no localized treatment (Steen. In Iran. 2007). The possiblility of researcher bias needs to be considered and while every attempt was made to blind the assessments. Another randomized controlled trial.RESEARCH AND EDUCATION in detail how the initial vasoconstriction. 1998. A systematic review demonstrated that localized cooling treatments were effective at reducing perineal pain. ice packs and epifoam (an anti-inflammatory steroid-based foam) (Steen et al. For these reasons research and development work was undertaken to produce a specifically designed cooling maternity gel pad for women to use (Steen and Cooper. the hardness and rigidity. Localized cooling treatments were not commonly used. 2000). before this trial. This trial has given Iranian women the opportunity for more effecitve pain relief.
Suturing technique and material. London Grundy L (1997) The role of the midwife in perineal wound care following childbirth. eds. British Journal of Midwifery 13(5): 311–4 Steen M (2007) Perineal tears and episiotomy: how do wounds heal? British Journal of Midwifery 15(5): 273–9 Steen M. can significantly contribute to the severity of perineal pain. n Perineal pain can dominate the experience of early motherhood. Jones P. Nursing 4(15): 18–22 Williams FLR.: CD000947. Lavender T. This trial has demonstrated evidence that localized cooling of the perineum reduces the intensity of pain and cooling gel pads appear to be the most effective treatment. Henshall NE. Johanson RB (2004) Absorbable synthetic versus catgut suture BRITISH JOURNAL OF MIDWIFERY. Chichester Kettle C. To cool or not to cool? British Journal of Midwifery 14(5): 304–8 Steen MP. In: MacMillan. Vicryle rapide has been recommended as a better suture material to use (Kettle et al. 2004. Schulz KF. Hills RK. J Wound Care 8(2): 87–90 Steen MP. RCOG. Pain management by Physiotherapy 2nd edn. Issue 1.pub2 Kettle C. Johanson RB (2002) Continuous versus interrupted perineal repair with standard or rapidly absorbed sutures after spontaneous vaginal births: a randomised controlled trial. Ogston SA (1998) Episiotomy and perineal tears in low risk UK primigravidae. urethra. Reed A (2000) Electrotherapy Explained. perineal muscles and anal sphincters. J Nurse Midwifery 36(3): 192–8 McMasters WC (1977) A literary review on ice therapy in injuries. n Treatments to alleviate perineal pain without any adverse affects on wound healing is an important aspect of midwifery care. vagina. Marchant P. Issue 4. Lancet 359: 2217–23 Low J. Norr K. Hills RK. VOL 17.RESEARCH AND EDUCATION of their behaviour being experimentally measured simply in response to the fact that they are being studied and not in response to any particular experimental manipulation. Butterworth Heinemann. Marchant P. Darby L. BJM Acknowledgments Monireh Poorjava. 1990). Cochrane Database of Systematic Reviews.1002/14651858. Cooper KJ (1997) A tool for assessing perineal trauma. It appears that women gain some pain relief from systemic and localized approaches and these should be readily available throughout the world. NCT. In: The Cochrane Library. Since this trial. Cooper KJ (1998) Cold therapy and perineal wounds: Too cool or not too cool? British Journal of Midwifery 6(9): 572–9 Steen MP. All primiparous women in the three treatment groups had similar demographic characteristics and also had a routine episiotomy which was sutured with chromic catgut (routine care in Iranian maternity hospitals). No. Hulme H (1993) The perineum in childbirth: a survey conducted by the National Childbirth Trust. In: Wells PE. Butterworth Heinemann. Br J Nurs 6(10): 584–8 Hill (1989) Effects of heat & cold on the perineum after episiotomy/laceration. British Journal of Midwifery 9(11): 690–4 Moher D. Begg L. Art.1002/14651858. MIDIRS. J Nurse Midwifery 35(4): 220–31 Sleep J (1990) Postnatal perineal care.: CD006304. Oxford McGuiness M. Wallace K (2007) Local cooling for relieving pain from perineal trauma sustained during childbirth. Easing genital tract trauma. Cooper KJ (1999) A new device for the treatment of perineal wounds. Barger MK (1990) Perineal care: Then and now. NOVEMBER 2009. In addition. Alexander. Guideline no 23. Statistician Mashhad university of Medical science-Iran Albers LL. Wound care. Gynecologist and Habibollah Esmaeilli. J Midwifery Womens Health 50(5): 365–72 Davidson NS (1974) REEDA: evaluating postpartum healing. J Public Health Med 20: 422–7 Conclusions Treatments to alleviate perineal pain without any adverse affects on wound healing and women’s views are important aspects of midwifery care. using chromic catgut can increase the intensity of pain and effect wound healing rates (Kettle and Johanson. 2002). Key Points n Perineal trauma can involve injury to the labia. DOI: 10. therefore. No.pub2 Greenshields W.CD006304. Midwifery practice: postnatal care. Bedrick EJ. eds. J Wound Care 6(9): 432–6 Steen MP. 2007). Teaf D. Walker J (2000) A randomised controlled trial to compare the effectiveness of ice packs and Epifoam with cooling maternity gel pads at alleviating postnatal perineal trauma. London Steen MP (2001) Do we care enough about perineal wounds? British Journal of Midwifery 9(5): 316–20 Steen MP (2002) A randomised controlled trial to evaluate the effectiveness of localised cooling treatments in alleviating perineal trauma: The APT Study. Sedler KD. John Wiley and Sons. Briggs M. n Women were more satisfied when applying cooling gel pads and this treatment appeared to assist in wound healing. material for perineal repair (Cochrane Review). Altman DA (2001) The consort statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. Cooper KJ. London Rhodes MA. Wound Care Clinic. There is evidence that routine episiotomy is not necessary and does not prevent perineal tears (Sleep. Evidence-Based Midwifery Journal 5(1): 16–22 Walker P (1990) Episiotomy: issues for practice. Cochrane Database of Systematic Reviews 2007. Kettle et al. DOI: 10. J Obstet Gynecol Neonatal Nurs 18: 124–9 Kettle C. Midwifery Digest 12(3): 373–6 Steen MP (2005) ‘I can’t sit down’. Nacion K (1991) Comparison between different perineal outcomes on tissue healing. this approach is not based on the best available evidence and is based on traditional obstetric practices. Peralta P (2005) Midwifery care measures in the second stage of Labor and reduction of genital tract trauma at birth: A randomized trial. More women reported higher levels of satisfaction when using cooling gel pads to alleviate perineal pain and this localized treatment also appears to assist in wound healing. RCM Midwives 4(8): 256–9 Steen M. NO 11 729 . Issue 4. Art. J Nurse Midwifery 19: 68 East CE. clitoris. 2004. Marchant PR (2001) Alleviating Perineal Trauma: the APT Study. Bowsher D. Frampton V. Lancet 357: 1191–4 Palastanga NP (1994) Heat and cold. Oxford RCOG (2004) Methods and Materials in Perineal Repair. Griffiths-Jones M. evidence to support changes in perineal management practices at the study hospital are being reviewed to update policies and procedures that are evidence based. Principles and Practice 3rd edn. Research evidence that demonstrates the most beneficial suturing technique and material needs to be implemented into clinical practice. Levy & Roch. Am J Sports Med 5(3): 124–6 Moffatt H. Ismail KMK (2007) Continuous versus interrupted sutures for repair of episiotomy or second degree tears.CD000947. n There is evidence that an episiotomy is more painful when compared with perineal tears and can take longer to heal. Marchant P (2007) Ice packs and cooling gel pads versus no localised treatment for relief of perineal pain: A randomised controlled trial. Gray R. Walkinshaw S (2001) Comparing administration of paracetamol for perineal pain. This is why it is important to measure several outcomes. Florey C du V. While this assisted in a ‘like-for-like’ critieria in their perineal managment and reduced potential bias in this trial. Mires GJ. King D (2006) Alleviating Postnatal Perineal Trauma. Midwifery 16(1): 48–55 Steen MP.
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