Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05908292
Study type	Interventional
Source	University of Calgary
Contact	Gina-Marie Cerantola, BSc, DPT
Phone	403-606-0953
Email	ginamarie.cerantola@ucalgary.ca
Status	Recruiting
Phase	N/A
Start date	September 21, 2023
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms