Piloting a Virtual Education and Psychosocial Skills Group for Postpartum Pelvic Floor Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Feasibility - retention; number of participants who complete at least four out of six sessions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Education and Psychosocial Skills Group
6-session, virtual psychosocial education and skills group, for individuals with birth-related pelvic floor conditions
干预措施: Education and Psychosocial Skills (Behavioral)
结局指标
主要结局
Feasibility - retention; number of participants who complete at least four out of six sessions
时间窗: Through study completion (average of 8 weeks)
Feasibility - time to complete recruitment (target N=16)
时间窗: Through recruitment completion
Feasibility of the Intervention Measure
时间窗: 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
时间窗: Weekly for 6 weeks
Acceptability of the Intervention Measure
时间窗: 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).
次要结局
- Pelvic Floor Impact Questionnaire(Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention)
- 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)
- Queensland Female Pelvic Floor Questionnaire(Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention)
- Brief COPE Inventory(Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention)
- Female Self Advocacy Scale(Pre-test administered immediately before 6-week intervention begins; post-test administered immediately after after completing 6-week intervention)
研究者
Kimberley.A.Johnson
Principal Investigator
Dartmouth-Hitchcock Medical Center