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Psychological Pain Treatment in Endometriosis

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by University of Aarhus
Sponsor:
Collaborators:
Aarhus University Hospital
TrygFonden, Denmark
Copenhagen University Hospital, Denmark
Endometriose Foreningen
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02761382
First received: April 12, 2016
Last updated: June 19, 2017
Last verified: April 2017
  Purpose
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).

Condition Intervention
Endometriosis Pelvic Pain Chronic Pain Other: Mindfulness-based psychological treatment Other: Non-specific psychological treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Mindfulness-based Psychological Pain Treatment in Endometriosis

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Pelvic pain measured on Numeric Rating Scale [ Time Frame: Change from pre-intervention to post-intervention (12 weeks) ]
    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 [ Time Frame: Change from pre-intervention to post-intervention (12 weeks) ]
    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 [ Time Frame: Change from pre-intervention to post-intervention (12 weeks) ]
    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 [ Time Frame: Change from pre-intervention to post-intervention (12 weeks) ]
    Pain acceptance measured by Chronic Pain Acceptance Questionnaire

  • Work Ability measured by the Work Ability Index [ Time Frame: Change from pre-intervention to post-intervention (12 weeks) ]
    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) [ Time Frame: Change from pre-intervention to post-intervention (12 weeks) ]
    Vaginal pressure pain detection threshold (PPDT) will be examined with a modified pressure algometer (palpometer) applicable for intravaginal pelvic floor muscle examination.


Other Outcome Measures:
  • Psychological flexibility measured by the Acceptance and Action Questionnaire-II [ Time Frame: Change from pre-intervention to post-intervention (12 weeks) ]
    Psychological flexibility will be measured by the Acceptance and Action Questionnaire-II (AAQ-II)

  • Mindfulness measured by the Five Facet Mindfulness Questionnaire [ Time Frame: Change from pre-intervention to post-intervention (12 weeks) ]
    Mindfulness will be measured by the Five Facet Mindfulness Questionnaire (FFMQ)


Estimated Enrollment: 100
Study Start Date: March 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness-based treatment

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:

  1. mindfulness-training (including meditation and yoga),
  2. therapy based on ACT, and
  3. patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.
Other: Mindfulness-based psychological treatment
Experimental: Non-specific treatment

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:

  1. relaxation and physical training,
  2. 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
  3. patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.
Other: Non-specific psychological treatment
No Intervention: Waiting list control
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.

  Eligibility

Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02761382

Contacts
Contact: Karina E Hansen + 45 87 16 54 68 keh@psy.au.dk
Contact: Lene Vase +45 87 16 58 28 lenevase@psy.au.dk

Locations
Denmark
Aarhus University Hospital, Department of Obstetrics and Gynecology Recruiting
Aarhus N, Denmark, 8200
Contact: Karina E Hansen    +45 87 16 54 68    keh@psy.au.dk   
Contact: Axel Forman    +45 78 45 33 54    af@clin.au.dk   
Copenhagen University Hospital, Department of Gynaecology Completed
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
TrygFonden, Denmark
Copenhagen University Hospital, Denmark
Endometriose Foreningen
Investigators
Study Chair: Axel Forman Aarhus University Hospital
Study Director: Lene Vase University of Aarhus
Principal Investigator: Karina E Hansen University of Aarhus
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02761382     History of Changes
Other Study ID Numbers: AUENDO
Study First Received: April 12, 2016
Last Updated: June 19, 2017

Additional relevant MeSH terms:
Chronic Pain
Endometriosis
Pelvic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 26, 2017