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

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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Episiotomy; Complications Scar Tissue Perineal Tear Vaginal Tear Resulting From Childbirth Procedure: Pelvic Floor Scar Tissue Self-Scar Massage Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : September 21, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars Tears

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
No Intervention: Standard Postnatal Care
This Arm will not be instructed in or perform self-scar massage to their pelvic floor scar tissue.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05908292


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

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Gina-Marie Cerantola, BSc, DPT    403-606-0953    ginamarie.cerantola@ucalgary.ca   
Sub-Investigator: Gina-Marie Cerantola, BSc, DPT         
Principal Investigator: Erin Brennand, MD, MSc         
Sponsors and Collaborators
University of Calgary
Alberta Health services
Alberta Innovates Health Solutions
Investigators
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Principal Investigator: Erin Brennand, MD, MSc University of Calgary
More Information
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT05908292    
Other Study ID Numbers: REB23-0097
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: December 13, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
Perineal Tear
Vaginal Tear
Episiotomy
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes