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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04057664
• Other study ID #: 2018-28
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Swiss Paraplegic Centre Nottwil
• Contact: Julia Kaufmann, MSc
• Phone: 041 939 49 00
• Email: julia.kaufmann[@]paraplegie.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Pain
• Chronic Pain
• Depression
• Endometriosis
• Pain, Abdominal
• Pain, Chronic
• Pain, Pelvic
• Pelvic Pain
• Sex Disorder
• Sexual Dysfunction, Physiological

Intervention

Behavioral:
• Learning of Coping Strategies
Group sessions with psychotherapy and physiotherapy

Locations

Country	Name	City	State
Switzerland	Center of Pain Medicine	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pelvic Pain Impact Questionnaire (PPIQ)	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.	baseline, 6 weeks, 3 months, 12 months
Secondary	Change in Sexual Functioning Questionnaire (CSFQ-14)	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.	baseline, 6 weeks, 3 months, 12 months
Secondary	Change in Female Sexual Distress Scale-Revised (FSDS-R)	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.	baseline, 6 weeks, 3 months, 12 months
Secondary	Change in Chronic Pain Grade Scale (CPGS)	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.	baseline, 6 weeks, 3 months, 12 months
Secondary	Change in Depression	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.	baseline, 6 weeks, 3 months, 12 months
Secondary	Change in Anxiety	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.	baseline, 6 weeks, 3 months, 12 months
Secondary	Change in Stress	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.	baseline, 6 weeks, 3 months, 12 months