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

Primary Purpose

Episiotomy; Complications, Scar Tissue

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Episiotomy Scar Tissue Self-Scar Massage
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Episiotomy; Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Age ≥18 years Primiparous 6-10 weeks postpartum after vaginal delivery with episiotomy 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: Self-reported current vaginal infection or urinary tract infection Self-reported gynecological surgery after delivery

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Episiotomy Self-Scar Massage

Standard Postnatal Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 15, 2023
Last Updated
September 25, 2023
Sponsor
University of Calgary
Collaborators
Alberta Health services, Alberta Innovates Health Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT05908292
Brief Title
Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy A Pilot RCT
Acronym
EPIS
Official Title
Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy The EPIS Trial: A Pilot Randomized Control Trial to Determine Feasibility
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services, Alberta Innovates Health Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episiotomy; Complications, Scar Tissue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Episiotomy Self-Scar Massage
Arm Type
Experimental
Arm Description
This Arm will be instructed in and perform self-scar massage to their episiotomy scar tissue.
Arm Title
Standard Postnatal Care
Arm Type
No Intervention
Arm Description
This Arm will not be instructed in or perform self-scar massage to their episiotomy scar tissue.
Intervention Type
Procedure
Intervention Name(s)
Episiotomy Scar Tissue Self-Scar Massage
Intervention Description
Self scar-massage intervention of healed episiotomy scar for 5 minutes, 3x/week for 6 weeks.
Primary Outcome Measure Information:
Title
Rate of Participant Recruitment
Description
To evaluate the rate of participant recruitment, the investigators will calculate how many participants were recruited on average per month per hospital site.
Time Frame
1 year
Title
Rate of Participant Attrition
Description
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.
Time Frame
1 year
Title
Number of Pelvic Floor Distress Inventory (PFDI-20) Outcome Measures with missing data
Description
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.
Time Frame
1 year
Title
Number of The Carol Scale with missing data
Description
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.
Time Frame
1 year
Title
Number of participants to complete self-scar massage protocol as intended
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Primiparous 6-10 weeks postpartum after vaginal delivery with episiotomy 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: Self-reported current vaginal infection or urinary tract infection Self-reported gynecological surgery after delivery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gina-Marie Cerantola, BSc, DPT
Phone
403-606-0953
Email
ginamarie.cerantola@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Brennand, MD, MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina-Marie Cerantola, BSc, DPT
Phone
403-606-0953
Email
ginamarie.cerantola@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Gina-Marie Cerantola, BSc, DPT
First Name & Middle Initial & Last Name & Degree
Erin Brennand, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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