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

Perineal Tear Clinical Trial

— EPIS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908292
• Other study ID #: REB23-0097
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: Gina-Marie Cerantola, BSc, DPT
• Phone: 403-606-0953
• Email: ginamarie.cerantola[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Episiotomy; Complications
• Perineal Tear
• Scar Tissue

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services, Alberta Innovates Health Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Participant Recruitment	To evaluate the rate of participant recruitment, the investigators will calculate how many participants were recruited on average per month per hospital site.	1 year
Primary	Rate of Participant Attrition	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.	1 year
Primary	Number of Pelvic Floor Distress Inventory (PFDI-20) Outcome Measures with missing data	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.	1 year
Primary	Number of The Carol Scale with missing data	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.	1 year
Primary	Number of participants to complete self-scar massage protocol as intended	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.	1 year