Psychosocial Skills Group for Pelvic Floor Symptoms

NCT07429539 | Completed

• 1 other identifier: STUDY02003254
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Floor Disorder; Pelvic Floor Awareness

Keywords

childbirth injuries; pelvic floor conditions

Outcome Measures

Primary Outcomes (5)

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

  Through study completion (average of 8 weeks)

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

  Through recruitment completion

• Feasibility of the Intervention Measure

  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).

  Post-test administered immediately after completing 6-week intervention

• Acceptability - Participant ratings of content relevance and helpfulness

  Weekly for 6 weeks

• Acceptability of the Intervention Measure

  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

Secondary Outcomes (8)

• Patient Health Questionnaire

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

• Perinatal Anxiety Screening Scale

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

• Barkin Index of Maternal Functioning

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

• University of Washington Self-Efficacy Scale

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

• Pelvic Floor Impact Questionnaire

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

Study Arms (1)

Education and Psychosocial Skills Group

EXPERIMENTAL

6-session, virtual psychosocial education and skills group, for individuals with birth-related pelvic floor conditions

Behavioral: Education and Psychosocial Skills

Interventions

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.

Education and Psychosocial Skills Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 24, 2026
• Study Start: February 17, 2026
• Primary Completion: May 19, 2026
• Study Completion: May 19, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

US (1)