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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04057664
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

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
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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : March 23, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Group/Cohort 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with chronic pelvic or belly pain, participating in our multimodal group therapy
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057664


Contacts
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Contact: Julia Kaufmann, MSc 041 939 49 00 julia.kaufmann@paraplegie.ch

Locations
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Switzerland
Center of Pain Medicine
Nottwil, LU, Switzerland, 6207
Contact: Julia Kaufmann, MSc    041 939 49 00    julia.kaufmann@paraplegie.ch   
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil

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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT04057664    
Other Study ID Numbers: 2018-28
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swiss Paraplegic Centre Nottwil:
Coping
Multidisciplinary
Group Therapy
Psychotherapy
Physiotherapy
Additional relevant MeSH terms:
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Endometriosis
Sexual Dysfunction, Physiological
Chronic Pain
Pelvic Pain
Abdominal Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Genital Diseases, Male
Signs and Symptoms, Digestive