Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT
NCT ID: NCT05908292
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
130 participants
INTERVENTIONAL
2023-09-21
2024-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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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.
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.
Standard Postnatal Care
This Arm will not be instructed in or perform self-scar massage to their pelvic floor scar tissue.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 gynecological surgery after delivery
18 Years
FEMALE
Yes
Sponsors
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Alberta Health services
OTHER
Alberta Innovates Health Solutions
OTHER
University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Erin Brennand, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Gina-Marie Cerantola, BSc, DPT
Role: primary
Other Identifiers
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REB23-0097
Identifier Type: -
Identifier Source: org_study_id