EPIS: Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy A Pilot RCT
Study Details
Study Description
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 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, and 6-10 weeks postpartum after vaginal delivery with healed episiotomy as confirmed to them by their maternity care provider or family doctor at their 6 week postpartum check. 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 (between 6-10 weeks postpartum) and then repeated 6 weeks later and again at 6 months postpartum.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Episiotomy Self-Scar Massage This Arm will be instructed in and perform self-scar massage to their episiotomy scar tissue. |
Procedure: Episiotomy Scar Tissue Self-Scar Massage
Self scar-massage intervention of healed episiotomy scar 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 episiotomy scar tissue. |
Outcome Measures
Primary Outcome Measures
- Rate of Participant Recruitment [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 [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 [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 [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 [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
Criteria
Inclusion Criteria:
-
Age ≥18 years
-
Primiparous
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6-10 weeks postpartum after vaginal delivery with episiotomy
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Healed episiotomy as confirmed to them by their maternity care provider or family doctor at their postpartum check
-
Sufficient proficiency in English to understand intervention instructional video and complete written questionnaires.
Exclusion Criteria:
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Self-reported current vaginal infection or urinary tract infection
-
Self-reported gynecological surgery after delivery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Calgary | Calgary | Alberta | Canada | T2N 1N4 |
Sponsors and Collaborators
- University of Calgary
- Alberta Health services
- Alberta Innovates Health Solutions
Investigators
- Principal Investigator: Erin Brennand, MD, MSc, University of Calgary
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REB23-0097