Back to resultsPsychological Pain Treatment in Endometriosis
Primary Purpose
Endometriosis, Pelvic Pain, Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mindfulness-based psychological treatment
Non-specific psychological treatment
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- Endometriosis diagnosed by laparoscopy or MRI.
- Moderate to severe endometriosis-related chronic pelvic pain.
- Relevant clinical and surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis have been tried.
Exclusion Criteria:
- Fibromyalgia, Colitis Chron or Colitis Ulcerosa
- Severe psychiatric diagnosis
- Pregnancy or planned pregnancy during the study period
Sites / Locations
- Aarhus University Hospital, Department of Obstetrics and Gynecology
- Copenhagen University Hospital, Department of Gynaecology
- North Denmark Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Mindfulness-based treatment
Non-specific treatment
Waiting list control
Arm Description
The mindfulness-based psychological treatment consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Mindfulness-based stress reduction (MBSR), Mindfulness-based cognitive therapy (MBCT) and Acceptance and commitment therapy (ACT). The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include: mindfulness-training (including meditation and yoga), therapy based on ACT, and patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.
The non-specific general psychological treatment is matched the mindfulness-based psychological treatment and consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Client-centered therapy. The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include: relaxation and physical training, therapy based on the non-specific factors of psychological treatment which emphasize a focus on the relation and alliance between the therapist and the client and the therapist being a warm empathic, non-directive and unconditionally accepting support, and patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.
Participants in this arm will be on the waiting list to participate in one of the two experimental treatments after a period of six months. Participants will receive medical treatment as usual in this period.
Outcomes
Primary Outcome Measures
Pelvic pain measured on Numeric Rating Scale
Pain intensity (sensory) and pain unpleasantness (affective) will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a daily pain diary.
Secondary Outcome Measures
Quality of life measured by the Endometriosis Health Profile 30 questionnaire
Quality of life will be measured by the Endometriosis Health Profile 30 questionnaire (EHP-30) which is a patient generated questionnaire that measure endometriosis-related quality of life
Endometriosis related symptoms measured on Numeric Rating Scale
Dyspareunia, Dysmenorrhea, Dyschezia, Dysuria, Tiredness, Constipation, Diarrhea, Nausea and Vomiting will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a weekly diary.
Pain acceptance measured by Chronic Pain Acceptance Questionnaire
Pain acceptance measured by Chronic Pain Acceptance Questionnaire
Work Ability measured by the Work Ability Index
Work ability will be measured by the Work Ability Index (WAI) which is a questionnaire used to measure changes in work ability due to a specific intervention
Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)
Vaginal pressure pain detection threshold (PPDT) will be examined with a modified pressure algometer (palpometer) applicable for intravaginal pelvic floor muscle examination.
Full Information
NCT ID
NCT02761382
First Posted
April 12, 2016
Last Updated
May 17, 2022
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, TrygFonden, Denmark, Copenhagen University Hospital, Denmark, Endometriose Foreningen
1. Study Identification
Unique Protocol Identification Number
NCT02761382
Brief Title
Psychological Pain Treatment in Endometriosis
Official Title
Mindfulness-based Psychological Pain Treatment in Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, TrygFonden, Denmark, Copenhagen University Hospital, Denmark, Endometriose Foreningen
4. Oversight
5. Study Description
Brief Summary
This study evaluates the effects of psychological treatment on pain, quality of life and work ability among women with endometriosis related chronic pelvic pain in a three-armed, randomised study. One group will receive mindfulness-based psychological treatment, the second group will receive a non-specific general psychological treatment (a psychological placebo) and the third group will be a waiting list control (treatment as usual).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Pelvic Pain, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based treatment
Arm Type
Experimental
Arm Description
The mindfulness-based psychological treatment consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Mindfulness-based stress reduction (MBSR), Mindfulness-based cognitive therapy (MBCT) and Acceptance and commitment therapy (ACT). The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include:
mindfulness-training (including meditation and yoga),
therapy based on ACT, and
patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.
Arm Title
Non-specific treatment
Arm Type
Experimental
Arm Description
The non-specific general psychological treatment is matched the mindfulness-based psychological treatment and consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Client-centered therapy. The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include:
relaxation and physical training,
therapy based on the non-specific factors of psychological treatment which emphasize a focus on the relation and alliance between the therapist and the client and the therapist being a warm empathic, non-directive and unconditionally accepting support, and
patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.
Arm Title
Waiting list control
Arm Type
No Intervention
Arm Description
Participants in this arm will be on the waiting list to participate in one of the two experimental treatments after a period of six months. Participants will receive medical treatment as usual in this period.
Intervention Type
Other
Intervention Name(s)
Mindfulness-based psychological treatment
Intervention Type
Other
Intervention Name(s)
Non-specific psychological treatment
Primary Outcome Measure Information:
Title
Pelvic pain measured on Numeric Rating Scale
Description
Pain intensity (sensory) and pain unpleasantness (affective) will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a daily pain diary.
Time Frame
Change from pre-intervention to post-intervention (12 weeks)
Secondary Outcome Measure Information:
Title
Quality of life measured by the Endometriosis Health Profile 30 questionnaire
Description
Quality of life will be measured by the Endometriosis Health Profile 30 questionnaire (EHP-30) which is a patient generated questionnaire that measure endometriosis-related quality of life
Time Frame
Change from pre-intervention to post-intervention (12 weeks)
Title
Endometriosis related symptoms measured on Numeric Rating Scale
Description
Dyspareunia, Dysmenorrhea, Dyschezia, Dysuria, Tiredness, Constipation, Diarrhea, Nausea and Vomiting will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a weekly diary.
Time Frame
Change from pre-intervention to post-intervention (12 weeks)
Title
Pain acceptance measured by Chronic Pain Acceptance Questionnaire
Description
Pain acceptance measured by Chronic Pain Acceptance Questionnaire
Time Frame
Change from pre-intervention to post-intervention (12 weeks)
Title
Work Ability measured by the Work Ability Index
Description
Work ability will be measured by the Work Ability Index (WAI) which is a questionnaire used to measure changes in work ability due to a specific intervention
Time Frame
Change from pre-intervention to post-intervention (12 weeks)
Title
Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)
Description
Vaginal pressure pain detection threshold (PPDT) will be examined with a modified pressure algometer (palpometer) applicable for intravaginal pelvic floor muscle examination.
Time Frame
Change from pre-intervention to post-intervention (12 weeks)
Other Pre-specified Outcome Measures:
Title
Psychological flexibility measured by the Acceptance and Action Questionnaire-II
Description
Psychological flexibility will be measured by the Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame
Change from pre-intervention to post-intervention (12 weeks)
Title
Mindfulness measured by the Five Facet Mindfulness Questionnaire
Description
Mindfulness will be measured by the Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame
Change from pre-intervention to post-intervention (12 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Endometriosis diagnosed by laparoscopy or MRI.
Moderate to severe endometriosis-related chronic pelvic pain.
Relevant clinical and surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis have been tried.
Exclusion Criteria:
Fibromyalgia, Colitis Chron or Colitis Ulcerosa
Severe psychiatric diagnosis
Pregnancy or planned pregnancy during the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Forman
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lene Vase
Organizational Affiliation
University of Aarhus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karina E Hansen
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Department of Obstetrics and Gynecology
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Copenhagen University Hospital, Department of Gynaecology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
North Denmark Regional Hospital
City
Hjørring
Country
Denmark
12. IPD Sharing Statement
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Psychological Pain Treatment in Endometriosis
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