A Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic and Chronic Belly Pain

Recruiting

• Conditions: Pain, Chronic; Pain, Pelvic; Pain, Abdominal; Sex Disorder; Depression; Endometriosis
• Interventions: Behavioral: Learning of Coping Strategies

• Registration Number: NCT04057664
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

Brief Summary

The project investigates the situation of patients with chronic pelvic and chronic belly pain before and after our group therapy.

Detailed Description

To treat patients with chronic pelvic and belly pain in an interdisciplinary way, we developped a group therapy consisting of twelve sessions and a booster session. The therapy is based on the bio-psycho-social model of pain and includes group sessions of psychotherapy as well as physiotherapy.

All patients fill in questionnaires (concerning pain impact, pain chronicity, depression, anxiety, stress, well-being and sexuality) before and after the therapy as well as three and twelve months after.

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Study Start: 2020-09-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-28
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Women with chronic pelvic pain or belly pain participating in our group therapy who give their consent to the analysis of their data for the study

Exclusion Criteria

• No participation in the group therapy
• Finishing the group therapy prematurely (>3 missed sessions)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multidisciplinary Group Therapy	Learning of Coping Strategies	Multidisciplinary group therapy for women with chronic pelvic or belly pain

Primary Outcome Measures

Name	Time	Method
Change in Pelvic Pain Impact Questionnaire (PPIQ)	baseline, 6 weeks, 3 months, 12 months	Self reported questionnaire with 8 questions to assess the impact of pelvic pain on quality of life, daily activities and emotional life. Each questions is scored 0-4, yielding a total from 0 and 32.

Secondary Outcome Measures

Name	Time	Method
Change in Female Sexual Distress Scale-Revised (FSDS-R)	baseline, 6 weeks, 3 months, 12 months	Self-reported questionnaire assessing distress associated with sexual dysfunction. Each questions is scored using a 5-point Likert scale (0=never to 4=always). Total scores range from 0 to 52, with higher scores indicating greater levels of sexually related distress.
Change in Anxiety	baseline, 6 weeks, 3 months, 12 months	Subscale of Depression Anxiety and Stress Scale (DASS) questionnaire. Self-reported questionnaire with 14 questions assessing anxiety. Each questions is scored using a 4-point Likert scale (0=does not apply at all to 3=apply very much). Total sub-scores range from 0 to 42.
Change in Stress	baseline, 6 weeks, 3 months, 12 months	Subscale of Depression Anxiety and Stress Scale (DASS) questionnaire. Self-reported questionnaire with 14 questions assessing stress. Each questions is scored using a 4-point Likert scale (0=does not apply at all to 3=apply very much). Total sub-scores range from 0 to 42.
Change in Sexual Functioning Questionnaire (CSFQ-14)	baseline, 6 weeks, 3 months, 12 months	Self-reported questionnaire with 14 questions assessing comorbidity- or medication-related sexual dysfunction. Each questions is scored using a 5-point Likert scale. Total scores range from 14 to 70, with lower scores indicating greater levels of sexual dysfunction.
Change in Chronic Pain Grade Scale (CPGS)	baseline, 6 weeks, 3 months, 12 months	Self-reported questionnaire with 3 questions assessing the presence of chronic pain at the site of injury. Each questions is scored using a 11-point Likert scale. Total scores range from 0 to 30, with higher scores indicating more pain.
Change in Depression	baseline, 6 weeks, 3 months, 12 months	Subscale of Depression Anxiety and Stress Scale (DASS) questionnaire. Self-reported questionnaire with 14 questions assessing depression. Each questions is scored using a 4-point Likert scale (0=does not apply at all to 3=apply very much). Total sub-scores range from 0 to 42.

Trial Locations

Locations (1)

Center of Pain Medicine; 🇨🇭 Nottwil, LU, Switzerland