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

University of Calgary

Status: Enrolling

Conditions: Episiotomy; Complications; Vaginal Tear Resulting From Childbirth; Scar Tissue; Perineal Tear

Treatments: Procedure: Pelvic Floor Scar Tissue Self-Scar Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT05908292

REB23-0097

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Episiotomy and Vaginal/Perineal Tear Self-Scar Massage

Experimental group

Description:

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

Treatment:

Procedure: Pelvic Floor Scar Tissue Self-Scar Massage

Standard Postnatal Care

No Intervention group

Description:

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