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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education and Psychosocial Skills Group | Experimental | 6-session, virtual psychosocial education and skills group, for individuals with birth-related pelvic floor conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention |
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Interested participants are eligible to participate if they:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
De-identified data may be shared upon request, pending updated data sharing agreement forms.
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| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention |
| D052801 | Male Urogenital Diseases |