The Good Pain Consultation in Endometriosis.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-50
SponsorSorlandet Hospital HF
About this trial
This PhD project investigates the effect of "the good pain consultation" and early integration of biopsychosocial pain education with current standard management of endometriosis. Our goal is to facilitate self-management of pain and improve health-related quality of life (HRQOL) using limited resources.
Our research question is: Does a good pain consultation improve pain self-efficacy and HRQOL, compared to usual care at 3 months and 1 year.?
Researchers will compare a good pain consultation to a control group that will receive usual care.
Participants will:
Attend a consultation and biopsychososial pain education plus usual care or usual care alone.
They will answer questions in an internet-based questionnaires three times point during the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
biological women
Disqualifiers
not speaking norwegian
Trial design
Design model
Parallel
Treatments tested in this trial
pain consultation, biopsychosocial pain education + usual care
Other interventionParticipants will receive a link to a digital pain education program. The program will include standard information about endometriosis, but will also introduce a biopsychosocial understanding of pain including influence of psychological factors such as excessive worry, stress, sleep disturbance and emotional distress. Self-management strategies including physical activity, relaxation and breathing techniques, cognitive techniques, psychosocial support and appropriate use of pain medication and supplemental treatment (e.g. physical therapy, TENS, heat), will be introduced. Participants will then attend a single "good pain consultation", a patient-centered consultation with a clinician associated with the project, in which content from the educational package will be reinforced. The consultation will provide the opportunity to address the biopsychosocial factors including anxiety, previous trauma, emotional distress etc. Shared decision-making regarding preferred self-management strat
Usual Care
Other interventionUsual follow up at the department of gynecology
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: intervention groupExperimental treatment 1 intervention
Group B: control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
The Pain Self-Efficacy Questionaire
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10 item self-report questionnaire which assesses confidence people with ongoing pain have in performing activities despite pain. Self-efficacy regarding household chores, socializing, work and coping without medication are assessed. Each item is scored on a 6-point scale, for a total raw score of 0-10 where high scores indicate greater levels of confidence in dealing with pain. The PSEQ is translated to Norwegian and used in previous Norwegian studies.
Time frame
The participants will report the outcome measures at baseline, after 3 and after 12 months.Secondary outcomes
1
The Short Form-12/Rand 12 Health Survey
SF-12 is a tool for assessing HRQOL, encompassing eight health domains: physical functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, social functioning, and mental health. These domains form two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Time frame
The participants will report the outcome measures at baseline, after 3 and after 12 months.2
A single question about Quality of Life
They will be asked: "All in all, how satisfied are you with your life right now?" we are using a scale from 0 to 10, where 0 means not at all satisfied and 10 means very satisfied.
Time frame
The participants will report the outcome measures at baseline, after 3 and after 12 months.3
Pain catastrophizing scale (PCS)
PCS measures pain catastrophizing and "exaggerated negative orientation toward pain stimuli and pain experience". The scale consists of 13 items and includes subscale scores for rumination, magnification and helplessness.
Time frame
The participants will report the outcome measures at baseline, after 3 and after 12 months.4
The Hopkins Symptom Checklist (HSCL-10).
The Hopkins Symptom Checklist (HSCL-10) is assessing emotional distress. The HSCL-10 consists of 10 questions assessing symptoms of anxiety and depression (range 1 to 4, most symptoms). Scores ≥1.75 are indicative of increased emotional distress.
Time frame
The participants will report the outcome measures at baseline, after 3 and after 12 months.Sponsors and contacts
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Source ClinicalTrials.gov