Pelvic Floor DisorderNCT07429539
Psychosocial Skills Group for Pelvic Floor Symptoms
A study testing Education and Psychosocial Skills in people with Pelvic Floor Disorder and Pelvic Floor Awareness, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorder, Pelvic Floor Awareness
- What is being tested?
- Education and Psychosocial Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to 19 May 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: 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.
- Conditions
- Pelvic Floor Disorder, Pelvic Floor Awareness
- Being tested
- Education and Psychosocial Skills
- Keywords
- childbirth injuries, pelvic floor conditions
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Psychosocial SkillsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education and Psychosocial Skills Group | Experimental | 6-session, virtual psychosocial education and skills group, for individuals with birth-related pelvic floor conditions Receives: Behavioral: Education and Psychosocial Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - retention; number of participants who complete at least four out of six sessions
Measured: Through study completion (average of 8 weeks)
Feasibility - time to complete recruitment (target N=16)
Measured: 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).
Measured: Post-test administered immediately after completing 6-week intervention
Acceptability - Participant ratings of content relevance and helpfulness
Measured: 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).
Measured: Post-test administered immediately after completing 6-week intervention
Secondary outcomes (8)
Patient Health Questionnaire
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.
Measured: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
Perinatal Anxiety Screening Scale
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.
Measured: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
Barkin Index of Maternal Functioning
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.
Measured: 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
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.
Measured: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
Pelvic Floor Impact Questionnaire
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.
Measured: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
Queensland Female Pelvic Floor Questionnaire
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.
Measured: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
Brief COPE Inventory
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.
Measured: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
Female Self Advocacy Scale
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.
Measured: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start17 Feb 2026
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisorderStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberley.A.Johnson, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429539
- Sponsor's protocol ID
- STUDY02003254
- Status last verified
- May 2026
- First submitted
- 21 Jan 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data may be shared upon request, pending updated data sharing agreement forms.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Virtual Education and Psychosocial Skills Group for Postpartum Pelvic Floor Symptoms
- ClinicalTrials.gov ID
- NCT07429539
- Acronym / sponsor ID
- STUDY02003254
- Conditions
- Pelvic Floor Disorder, Pelvic Floor Awareness
- Keywords
- childbirth injuries, pelvic floor conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 24 Feb 2026 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education and Psychosocial Skills Group | Experimental | Behavioral: Education and Psychosocial Skills6-session, virtual psychosocial education and skills group, for individuals with birth-related pelvic floor conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Education and Psychosocial SkillsParticipants 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. | Behavioural | Education and Psychosocial Skills Group |
Primary outcome
Feasibility - retention; number of participants who complete at least four out of six sessions
Time frame: Through study completion (average of 8 weeks)
Feasibility - time to complete recruitment (target N=16)
Time frame: Through recruitment completion
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).
Acceptability - Participant ratings of content relevance and helpfulness
Time frame: Weekly for 6 weeks
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).
8 secondary outcomes
Patient Health Questionnaire
Time frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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
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
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
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
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
Brief COPE Inventory
Time frame: Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention
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
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 28 May 2026.
- Individual participant dataSharing planned: Undecided. De-identified data may be shared upon request, pending updated data sharing agreement forms.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Psychosocial Skills in people with Pelvic Floor Disorder and Pelvic Floor Awareness, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 0 inclusion and 4 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 28 May 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 United States. 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?
Feasibility - retention; number of participants who complete at least four out of six sessions (time frame: Through study completion (average of 8 weeks)). 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 28 May 2026.