Clinical trial NCT05908292: Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT
Official title: Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue The EPIS Trial: A Pilot Randomized Control Trial to Determine Feasibility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Episiotomy; Complications
Scar Tissue
Perineal Tear
Vaginal Tear Resulting From Childbirth
Keywords: Perineal Tear
Vaginal Tear
Episiotomy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: Alberta Innovates Health Solutions
First posted: 2023-06-18
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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 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

Primary outcomes:
measure: Rate of Participant Recruitment
timeFrame: 1 year
measure: Rate of Participant Attrition
timeFrame: 1 year
measure: Number of Pelvic Floor Distress Inventory (PFDI-20) Outcome Measures with missing data
timeFrame: 1 year
measure: Number of The Carol Scale with missing data
timeFrame: 1 year
measure: Number of participants to complete self-scar massage protocol as intended
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Erin Brennand, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: