- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07429539
Psychosocial Skills Group for Pelvic Floor Symptoms
Piloting a Virtual Education and Psychosocial Skills Group for Postpartum Pelvic Floor Symptoms
There is a critical need for evidence-based programs that address the educational needs and psychosocial impact of childbirth-related pelvic floor injuries and conditions in an accessible format. The purpose of this pilot study is to develop, implement, and evaluate the feasibility, acceptability, and preliminary effectiveness of a manualized 6-session psychosocial skills and education group for individuals with birth-related pelvic floor injuries and conditions. This group-based approach integrates psychoeducation, pain science, cognitive-behavioral techniques, acceptance-based and mindfulness skills to enhance quality of life and coping skills for those managing these conditions.
This research study will test whether a virtual education and psychosocial skills group can provide valuable resources and skill-building for people living with these conditions. The findings from this pilot study will help us understand whether this type of program is feasible, acceptable, and potentially beneficial, and will inform refinement of the group protocol and study procedures in preparation for a future randomized controlled trial.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Dartmouth Hitchcock Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Interested participants are eligible to participate if they:
- Are experiencing pelvic floor symptoms following vaginal delivery within the past year; this may include urinary or fecal incontinence, pelvic organ prolapse symptoms ("tampon falling out"), and pelvic pain.
- Believe that their pelvic floor symptoms are negatively impacting wellbeing and quality of life.
- Are under the care of a medical provider for management of physical symptoms (e.g., pelvic floor PT, urogynecologist, obstetrician gynecologist, primary care clinician, etc).
- Are English-speaking.
- Are comfortable participating in a virtual group-based setting.
Exclusion Criteria:
- Cognitive disability that prevents participants from understanding and engaging with spoken and written group content
- Suicidal thoughts or urges to harm oneself
- Lack of private space to join the group sessions from
- Current pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education and Psychosocial Skills Group
6-session, virtual psychosocial education and skills group, for individuals with birth-related pelvic floor conditions
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Participants will attend a 6-session, virtual psychosocial education and skills group, for individuals with birth-related pelvic floor conditions.
This is a non-randomized pilot feasibility study.
All enrolled participants will receive the same group content, with assessments conducted at baseline (pre-group), brief surveys after each session, and immediately following group completion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - retention; number of participants who complete at least four out of six sessions
Time Frame: Through study completion (average of 8 weeks)
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Through study completion (average of 8 weeks)
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Feasibility - time to complete recruitment (target N=16)
Time Frame: Through recruitment completion
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Through recruitment completion
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Feasibility of the Intervention Measure
Time Frame: Post-test administered immediately after completing 6-week intervention
|
4-item instrument measuring the feasibility of an intervention using a 5-point Likert scale, with higher scores reflecting higher feasibility.
Score range: 1-5 (score represents mean of items).
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Post-test administered immediately after completing 6-week intervention
|
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Acceptability - Participant ratings of content relevance and helpfulness
Time Frame: Weekly for 6 weeks
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Weekly for 6 weeks
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|
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Acceptability of the Intervention Measure
Time Frame: Post-test administered immediately after completing 6-week intervention
|
4-item instrument measuring the acceptability of an intervention using a 5-point Likert scale, with higher scores reflecting greater acceptability.
Score range: 1-5 (score represents mean of items).
|
Post-test administered immediately after completing 6-week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire
Time Frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
|
9-item depression measure, with each item scored on a 4-point Likert scale.
Score range: 0-27; higher scores reflect more severe depression symptoms.
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Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
|
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Perinatal Anxiety Screening Scale
Time Frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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31-item measure of perinatal anxiety, with each item scored on a 4-point Likert scale.
Score range: 0-93; higher scores reflect more severe anxiety symptoms.
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Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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Barkin Index of Maternal Functioning
Time Frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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20-item measure of maternal functioning, with each item scored on a 7-point Likert scale.
Score range 0-120; higher total scores reflect higher functioning.
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Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
|
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University of Washington Self-Efficacy Scale
Time Frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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6-item measure of chronic condition-related self-efficacy, with each item scored on a 5-point Likert scale.
Scores range from 6-30; higher scores reflect greater self-efficacy.
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Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
|
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Pelvic Floor Impact Questionnaire
Time Frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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21-item measure of pelvic floor symptom-related impact, with each item scored on a 4-point Likert scale.
Validated scoring formula results in a total score range of 0-300; higher scores reflect more symptom-related quality of life impairment.
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Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
|
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Queensland Female Pelvic Floor Questionnaire
Time Frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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42-item measure of pelvic floor symptom severity and associated level of bother across four categories (bladder function, bowel function, prolapse symtoms, sexual function), with each item scored on a 4-point Likert scale.
Scores for each domain range from 0-10; higher scores reflect greater symptom severity.
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Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
|
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Brief COPE Inventory
Time Frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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28-items measure of various coping strategies, each item scored on a 4-point Likert scale.
Scale scores range from 1-4 (representing mean of items); higher scores on each subscale indicate greater use of that coping strategy.
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Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
|
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Female Self Advocacy Scale
Time Frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
|
Female Self-Advocacy in Cancer Survivorship Scale (language modified; cancer survivorship --> pelvic floor symptom management); 20-item measure of health-related self-advocacy, with each item scored on a 6-point Likert scale.
Scores range from 20-120; higher scores reflect greater self-advocacy.
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Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY02003254
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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