Episiotomy Scar Massage for Postpartum Pelvic Health

(EPIS Trial)

Overseen By Gina-Marie Cerantola, BSc, DPT

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Vaginal infection, Urinary tract infection, Gynecological surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether massaging scar tissue from an episiotomy or vaginal tear can improve pelvic health after childbirth. Participants will either learn to perform this massage themselves (episiotomy scar tissue self-scar massage) or follow standard postnatal care without massage. Researchers aim to determine if the massage is easy to perform, if participants adhere to it, and how it affects pelvic health. This trial suits first-time mothers who had a vaginal birth with an episiotomy or tear and are within one year postpartum. Participants must also understand English to follow instructions and complete surveys. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance postnatal care for future mothers.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on postpartum pelvic health and scar massage, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that this self-scar tissue massage is safe for postpartum pelvic health?

Research has shown that massaging an episiotomy scar after childbirth is generally safe and well-received. This massage helps make the scar tissue more flexible and can reduce discomfort. Studies have not reported any serious side effects from this type of massage. Most people find it easy and safe to do at home. If healing has progressed well after childbirth, this massage might improve comfort and flexibility in the scar area. Always consult a healthcare provider before starting any new self-care routine to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about episiotomy scar tissue self-scar massage for postpartum pelvic health because it offers a non-invasive, self-administered approach that could empower new mothers to improve their own recovery. While standard treatments often involve physical therapy or simply waiting for natural healing, self-scar massage directly targets the scar tissue, potentially enhancing flexibility and reducing discomfort. This method is unique because it puts control in the hands of the patient, allowing for personalized care that could lead to better outcomes for postpartum recovery.

What evidence suggests that episiotomy scar tissue self-scar massage might be effective for postpartum pelvic health?

Research shows that gently massaging a scar might increase flexibility and reduce discomfort after childbirth. This practice could improve pelvic health and ease scar-related pain. Some studies suggest that similar self-care methods aid healing and reduce pain for women post-birth. Although specific data on this type of massage remains limited, the body's general response to massage supports the idea. This trial will compare two groups: one group will perform self-scar massage on their pelvic floor scar tissue, while the other will receive standard postnatal care without massage. The trial aims to determine whether self-massage could be a simple and effective way to aid recovery after an episiotomy or tear. ^{1 2 3 4 6}

Who Is on the Research Team?

Erin Brennand, MD, MSc

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for first-time mothers over 18, within 6-10 weeks postpartum after a vaginal delivery with episiotomy. They must have healed scars as confirmed by their doctor and be able to understand English well enough to follow an instructional video and fill out questionnaires.

Inclusion Criteria

Sufficient proficiency in English to understand intervention instructional video and complete written questionnaires.

Healed episiotomy as confirmed to them by their maternity care provider or family doctor at their postpartum check

I am 6-10 weeks postpartum after a vaginal delivery with an episiotomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group perform self-scar tissue massage for 6 weeks, while the control group receives routine postnatal care.

6 weeks

Baseline assessment at start, follow-up at 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments repeated 18 weeks after baseline.

12 weeks

Follow-up assessment at 18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Episiotomy Scar Tissue Self-Scar Massage

Trial Overview The study tests if self-scar tissue massage on the perineal area can improve pelvic health in new moms. Participants will either perform self-massage following an instructional video or receive routine care without massage, to compare outcomes using pelvic health questionnaires.

How Is the Trial Designed?

Group I: Episiotomy and Vaginal/Perineal Tear Self-Scar Massage Experimental Treatment 1 Intervention

This Arm will be instructed in and perform self-scar massage to their pelvic floor scar tissue.

Group II: Standard Postnatal Care Active Control 1 Intervention

This Arm will not be instructed in or perform self-scar massage to their pelvic floor scar tissue.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

Citations

1. withpower.com withpower.com/trial/phase-cicatrix-6-2023-8d12f

Episiotomy Scar Massage for Postpartum Pelvic Health · ... The study will involve women who have given birth and have healed scars. The massage is expected to make the scar tissue more flexible and reduce discomfort.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05908292/optimizing-postpartum-pelvic-health-through-self-scar-tissue-massage-of-episiotomy-and-perineal-scar-tissue-a-pilot-rct

Optimizing Postpartum Pelvic Health Through Self-Scar ... The goal of this Pilot Randomized Control Trial (RCT) is to determine if a larger RCT evaluating the effect of self-scar tissue massage of ...

3. ucalgary.scholaris.ca ucalgary.scholaris.ca/items/f230cf2a-b4b0-4b77-a463-a4b8b71d5806

Feasibility of Postpartum Community Research - PRISM 1. Assess feasibility of a randomized controlled trial (RCT) investigating self-massage of postpartum pelvic floor scar tissue on pelvic health outcomes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9757658/

A Review of Episiotomy and Modalities for Relief ... Infrared lamp therapy and sitz baths are the two most effective and commonly used for episiotomy pain relief and wound healing.

5. researchgate.net researchgate.net/publication/308414766_Effect_of_Self_Perineal_Care_Instructions_on_Episiotomy_Pain_and_Wound_Healing_of_Postpartum_Women

Effect of Self Perineal Care Instructions on Episiotomy Pain ... The aim of this study was to evaluate the effect of self perineal care instructions on episiotomy pain and wound healing of postpartum women.

6. carolinapelvichealth.com carolinapelvichealth.com/perineal-tear-episiotomy-and-scar-recovery-pt-can-help/

Perineal tear, episiotomy and scar recovery: PT can help! Pelvic floor rehabilitation is available and effective to help you recover from perineal tearing and return to intimacy and exercise comfortably.