- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04057664
A Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic and Chronic Belly Pain
Managing the Pain - a Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic Pain and Chronic Belly Pain
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Canton of Lucerne
-
Nottwil, Canton of Lucerne, Switzerland, 6207
- Center of Pain Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Multidisciplinary Group Therapy
Multidisciplinary group therapy for women with chronic pelvic or belly pain
|
Group sessions with psychotherapy and physiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pelvic Pain Impact Questionnaire (PPIQ)
Time Frame: 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.
|
baseline, 6 weeks, 3 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sexual Functioning Questionnaire (CSFQ-14)
Time Frame: 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.
|
baseline, 6 weeks, 3 months, 12 months
|
|
Change in Female Sexual Distress Scale-Revised (FSDS-R)
Time Frame: 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.
|
baseline, 6 weeks, 3 months, 12 months
|
|
Change in Chronic Pain Grade Scale (CPGS)
Time Frame: 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.
|
baseline, 6 weeks, 3 months, 12 months
|
|
Change in Depression
Time Frame: 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.
|
baseline, 6 weeks, 3 months, 12 months
|
|
Change in Anxiety
Time Frame: 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.
|
baseline, 6 weeks, 3 months, 12 months
|
|
Change in Stress
Time Frame: 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.
|
baseline, 6 weeks, 3 months, 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pain
- Neurologic Manifestations
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Signs and Symptoms, Digestive
- Behavioral Symptoms
- Genital Diseases, Female
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Abdominal Pain
- Chronic Pain
- Depression
- Endometriosis
- Pelvic Pain
- Sexual Dysfunction, Physiological
Other Study ID Numbers
- 2018-28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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