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Completed

NCT Number: NCT07429539

Psychosocial Skills Group for 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.

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Key information

Conditions

Pelvic Floor Disorder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pelvic Floor Awareness Pelvic Floor Disorders Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education and Psychosocial Skills

Behavioral

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.

Primary outcomes

  1. Feasibility - retention; number of participants who complete at least four out of six sessions

    Time frame: Through study completion (average of 8 weeks)

  2. Feasibility - time to complete recruitment (target N=16)

    Time frame: Through recruitment completion

  3. 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).

  4. Acceptability - Participant ratings of content relevance and helpfulness

    Time frame: Weekly for 6 weeks

  5. 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).

Secondary outcomes

  1. 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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. Brief COPE Inventory

    Time frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention

    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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Piloting a Virtual Education and Psychosocial Skills Group for Postpartum Pelvic Floor Symptoms

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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