Episiotomy; ComplicationsEPISNCT05908292
Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT
A study testing Pelvic Floor Scar Tissue Self-Scar Massage in people with Episiotomy; Complications and Scar Tissue, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy; Complications, Scar Tissue, Perineal Tear
- What is being tested?
- Pelvic Floor Scar Tissue Self-Scar Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Self-reported current vaginal infection or urinary tract infection
- Self-reported gynecological surgery after delivery
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
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.
- Conditions
- Episiotomy; Complications, Scar Tissue, Perineal Tear, Vaginal Tear Resulting From Childbirth
- Being tested
- Pelvic Floor Scar Tissue Self-Scar Massage
- Keywords
- Perineal Tear, Vaginal Tear, Episiotomy
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Scar Tissue Self-Scar MassageProcedure or surgery
Self scar-massage intervention of healed pelvic floor scar tissue for 5 minutes, 3x/week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Episiotomy and Vaginal/Perineal Tear Self-Scar Massage | Experimental | This Arm will be instructed in and perform self-scar massage to their pelvic floor scar tissue. Receives: Procedure: Pelvic Floor Scar Tissue Self-Scar Massage |
| Standard Postnatal Care | No intervention | This Arm will not be instructed in or perform self-scar massage to their pelvic floor scar tissue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Participant Recruitment
To evaluate the rate of participant recruitment, the investigators will calculate how many participants were recruited on average per month per hospital site.
Measured: 1 year
Rate of Participant Attrition
To evaluate the rate of participant attrition, the investigators will calculate the number of participants that drop out of the study over the total number of participants that are randomized in the study over the study period.
Measured: 1 year
Number of Pelvic Floor Distress Inventory (PFDI-20) Outcome Measures with missing data
To evaluate the response rate and the completeness of the PFDI-20 the investigators will track how many questionnaires are not completed and determine if there is any missing data in the responses to the PFDI-20.
Measured: 1 year
Number of The Carol Scale with missing data
To evaluate the response rate and the completeness of the Carol Scale the investigators will track how many questionnaires are not completed and determine if there is any missing data in the responses to the Carol Scale.
Measured: 1 year
Number of participants to complete self-scar massage protocol as intended
To evaluate the acceptability of the self-scar massage intervention, the investigators will examine participants' reported intervention frequency and time of intervention on their records and note any deviation from the intervention protocol. Some participant interviews will be conducted from a program evaluation lens to determine how the intervention was received. Exemplar quotes will be used to describe participants experience of the self-scar massage intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start21 Sep 2023
- Primary completion9 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, Alberta Innovates Health Solutions
- Responsible party
- Sponsor
- Investigators
- Erin Brennand, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908292
- Sponsor's protocol ID
- REB23-0097
- Acronym
- EPIS
- Status last verified
- Dec 2024
- First submitted
- 15 May 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05908292
- Acronym / sponsor ID
- EPIS / REB23-0097
- Conditions
- Episiotomy; Complications, Scar Tissue, Perineal Tear, Vaginal Tear Resulting From Childbirth
- Keywords
- Perineal Tear, Vaginal Tear, Episiotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services, Alberta Innovates Health Solutions
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Episiotomy and Vaginal/Perineal Tear Self-Scar Massage | Experimental | Procedure: Pelvic Floor Scar Tissue Self-Scar MassageThis Arm will be instructed in and perform self-scar massage to their pelvic floor scar tissue. |
| Standard Postnatal Care | No intervention | –This Arm will not be instructed in or perform self-scar massage to their pelvic floor scar tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Self-reported current vaginal infection or urinary tract infection
- Self-reported gynecological surgery after delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Scar Tissue Self-Scar MassageSelf scar-massage intervention of healed pelvic floor scar tissue for 5 minutes, 3x/week for 6 weeks. | Procedure or surgery | Episiotomy and Vaginal/Perineal Tear Self-Scar Massage |
Primary outcome
Rate of Participant Recruitment
Time frame: 1 year
To evaluate the rate of participant recruitment, the investigators will calculate how many participants were recruited on average per month per hospital site.
Rate of Participant Attrition
Time frame: 1 year
To evaluate the rate of participant attrition, the investigators will calculate the number of participants that drop out of the study over the total number of participants that are randomized in the study over the study period.
Number of Pelvic Floor Distress Inventory (PFDI-20) Outcome Measures with missing data
Time frame: 1 year
To evaluate the response rate and the completeness of the PFDI-20 the investigators will track how many questionnaires are not completed and determine if there is any missing data in the responses to the PFDI-20.
Number of The Carol Scale with missing data
Time frame: 1 year
To evaluate the response rate and the completeness of the Carol Scale the investigators will track how many questionnaires are not completed and determine if there is any missing data in the responses to the Carol Scale.
Number of participants to complete self-scar massage protocol as intended
Time frame: 1 year
To evaluate the acceptability of the self-scar massage intervention, the investigators will examine participants' reported intervention frequency and time of intervention on their records and note any deviation from the intervention protocol. Some participant interviews will be conducted from a program evaluation lens to determine how the intervention was received. Exemplar quotes will be used to describe participants experience of the self-scar massage intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Episiotomy; Complications
Recruiting
Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy
Gynecological; Surgery (Previous), Causing Obstructed Labor
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Recruiting
Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia
Dyspareunia
Active, not recruiting
MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery
Perineal Scars, Delivery Complication
Active, not recruiting
Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women
Pelvic Floor Disorders, Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Brennand, MD, MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Scar Tissue Self-Scar Massage in people with Episiotomy; Complications and Scar Tissue, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Participant Recruitment (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.