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

Sponsor

Swiss Paraplegic Centre Nottwil (Other)

Overall Status

Recruiting

CT.gov ID

NCT04057664

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic Pain, Pelvic Pain, Abdominal Depression Sex Disorder Endometriosis	Behavioral: Learning of Coping Strategies

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 Design

Study Type:

Observational

Anticipated Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Multidisciplinary Group Therapy Multidisciplinary group therapy for women with chronic pelvic or belly pain	Behavioral: Learning of Coping Strategies Group sessions with psychotherapy and physiotherapy

Arm

Intervention/Treatment

Multidisciplinary Group Therapy

Multidisciplinary group therapy for women with chronic pelvic or belly pain

Behavioral: Learning of Coping Strategies

Group sessions with psychotherapy and physiotherapy

Outcome Measures

Primary Outcome Measures

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

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 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 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.
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.