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

Last updated: December 6, 2023
Sponsor: University of Calgary
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Treatment

Pelvic Floor Scar Tissue Self-Scar Massage

Episiotomy Scar Tissue Self-Scar Massage

Clinical Study ID

NCT05908292
REB23-0097
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years
  • Primiparous
  • Within 1 year postpartum after vaginal delivery with episiotomy and/orvaginal/perineal tear
  • Healed episiotomy and/or vagina/perineal tear as confirmed to them by their maternitycare provider or family doctor at their postpartum check or other appointment
  • Sufficient proficiency in English to understand intervention instructional video andcomplete written questionnaires.

Exclusion

Exclusion Criteria:

  • Self-reported current vaginal infection or urinary tract infection
  • Self-reported gynecological surgery after delivery

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Pelvic Floor Scar Tissue Self-Scar Massage
Phase:
Study Start date:
September 21, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 1N4
    Canada

    Active - Recruiting

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