Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT (EPIS)

• ClinicalTrials.gov Identifier: NCT05908292
• Recruitment Status: Recruiting
• First Posted: June 18, 2023
• Last Update Posted: December 13, 2023
• Sponsor: University of Calgary
• Collaborators: Alberta Health services; Alberta Innovates Health Solutions
• Information provided by (Responsible Party): University of Calgary

Tracking Information

• First Submitted Date: May 15, 2023
• First Posted Date: June 18, 2023
• Last Update Posted Date: December 13, 2023
• Actual Study Start Date: September 21, 2023
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 8, 2023)

• Rate of Participant Recruitment [ Time Frame: 1 year ]
  To evaluate the rate of participant recruitment, the investigators will calculate how many participants were recruited on average per month per hospital site.
• Rate of Participant Attrition [ Time Frame: 1 year ]
  To evaluate the rate of participant attrition, the investigators will calculate the number of participants that drop out of the study over the total number of participants that are randomized in the study over the study period.
• Number of Pelvic Floor Distress Inventory (PFDI-20) Outcome Measures with missing data [ Time Frame: 1 year ]
  To evaluate the response rate and the completeness of the PFDI-20 the investigators will track how many questionnaires are not completed and determine if there is any missing data in the responses to the PFDI-20.
• Number of The Carol Scale with missing data [ Time Frame: 1 year ]
  To evaluate the response rate and the completeness of the Carol Scale the investigators will track how many questionnaires are not completed and determine if there is any missing data in the responses to the Carol Scale.
• Number of participants to complete self-scar massage protocol as intended [ Time Frame: 1 year ]
  To evaluate the acceptability of the self-scar massage intervention, the investigators will examine participants' reported intervention frequency and time of intervention on their records and note any deviation from the intervention protocol. Some participant interviews will be conducted from a program evaluation lens to determine how the intervention was received. Exemplar quotes will be used to describe participants experience of the self-scar massage intervention.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT
• Official Title: Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue The EPIS Trial: A Pilot Randomized Control Trial to Determine Feasibility

Brief Summary

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 episiotomy and/or vagina/perineal tear scar tissue on pelvic health outcomes is feasible.

The main questions it aims to answer are:

Can the investigators recruit 130 participants and aim for 80% retention of participants in this study?

Are the response rates to questionnaires and completeness of questionnaires acceptable?

Do the participants find the self-scar tissue massage intervention easy and acceptable to perform and do they adhere to the protocol?

Type of Study: Clinical Trial

Participant Population/Health Conditions: The participant population will be 18 years of age or older, primiparous, within 1 year postpartum after vaginal delivery with healed episiotomy and/or vaginal perineal tear(s) as confirmed to them by their maternity care provider or family doctor at their 6 week postpartum check or other appointment. The participants will also need to have sufficient proficiency in English to understand intervention instructional video and complete written questionnaires.

Investigators will compare the scores on two reliable and validated pelvic health questionnaires in those in the intervention and control groups. The intervention group will be provided an instructional video on self-scar tissue massage and asked to perform self-scar massage and record their intervention and experience over a 6-week period. The control group will receive routine postnatal care (no self-scar massage training or performance). Patient medical records will be used to collect demographic data and labour and delivery characteristics. Two reliable and validated pelvic health questionnaires will be used for outcome measures. Baseline outcomes will be performed at the start of the study and then repeated 6 weeks later and again 18 weeks later.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Other

Condition

• Episiotomy; Complications
• Scar Tissue
• Perineal Tear
• Vaginal Tear Resulting From Childbirth

Intervention

Procedure: Pelvic Floor Scar Tissue Self-Scar Massage

Self scar-massage intervention of healed pelvic floor scar tissue for 5 minutes, 3x/week for 6 weeks.

Study Arms

• Experimental: Episiotomy and Vaginal/Perineal Tear Self-Scar Massage
  This Arm will be instructed in and perform self-scar massage to their pelvic floor scar tissue.
  Intervention: Procedure: Pelvic Floor Scar Tissue Self-Scar Massage
• No Intervention: Standard Postnatal Care
  This Arm will not be instructed in or perform self-scar massage to their pelvic floor scar tissue.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 8, 2023): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age ≥18 years
• Primiparous
• Within 1 year postpartum after vaginal delivery with episiotomy and/or vaginal/perineal tear
• Healed episiotomy and/or vagina/perineal tear as confirmed to them by their maternity care provider or family doctor at their postpartum check or other appointment
• Sufficient proficiency in English to understand intervention instructional video and complete written questionnaires.

Exclusion Criteria:

• Self-reported current vaginal infection or urinary tract infection
• Self-reported gynecological surgery after delivery

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Gina-Marie Cerantola, BSc, DPT; 403-606-0953; ginamarie.cerantola@ucalgary.ca

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT05908292
• Other Study ID Numbers: REB23-0097
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Calgary
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Calgary
• Original Study Sponsor: Same as current

Collaborators

• Alberta Health services
• Alberta Innovates Health Solutions

Investigators

• Principal Investigator: Erin Brennand, MD, MSc; University of Calgary

• PRS Account: University of Calgary
• Verification Date: May 2023