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| ID | Type | Description | Link |
|---|---|---|---|
| 818856 | Other Identifier | Regional Committes for Medical and Health Research Ethics South-East Norway |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | pain consultation, biopsychosocial pain education + usual care |
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| control group | Other | usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pain consultation, biopsychosocial pain education + usual care | Other | Participants 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The participants will report the outcome measures at baseline, after 3 and after 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | The participants will report the outcome measures at baseline, after 3 and after 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inger Johanne W Hansen, MD | Contact | +47 38149424 | inger.johanne.hansen@sshf.no | |
| Alexandra Christine Hott, MD, PhD | Contact | +47 38149348 | alexandra.hott@sshf.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorlandet Sykehus HF | Recruiting | Kristiansand | Agder | 4600 | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 17, 2025 | Sep 17, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004412 | Dysmenorrhea |
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Randomised controlled trial
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Blinded outcome assessment and data analysis. Manuscript first draft will be written blinded.
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| Usual Care | Other | Usual follow up at the department of gynecology |
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| 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. | The participants will report the outcome measures at baseline, after 3 and after 12 months. |
| 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. | The participants will report the outcome measures at baseline, after 3 and after 12 months. |
| 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. | The participants will report the outcome measures at baseline, after 3 and after 12 months. |
| Numeric rating scales (NRS) | Numeric rating scales (NRS) rating from 0 to 10 measuring pain intensity. 0 means no pain and 10 means worst possible pain. Three NRS measures will be done registering worst pain intensity and bothersomeness of pain, during the past month | The participants will report the outcome measures at baseline, after 3 and after 12 months. |
| The Decreased Sexual Desire Screener (DSDS) | (DSDS) is a simple, validated diagnostic tool to help to identify and discuss hypoactive sexual dysfunction among women. | The participants will report the outcome measures at baseline, after 3 and after 12 months. |
| The Brief Illness Perception Questionnaire (Brief IPQ) | Brief IPQ is used to assess the cognitive and emotional perception of their illness and consists of nine questions. Answers are scored on a Likert scale from 0-10 scale in the first eight question and the latter question has an open-ended respons. Higher scores indicate more threatening/negative views of their pelvic pain. | The participants will report the outcome measures at baseline, after 3 and after 12 months. |
| 2016 Fibromyalgia diagnostic criteria | The 2016 Fibromyalgia diagnostic criteria are used to identify fibromyalgia based on symptom severity and pain distribution. The criteria include two main components:
Diagnosis is met if: WPI ≥ 7 and SSS ≥ 5, or WPI 4-6 and SSS ≥ 9 and symptoms have been present at a similar level for at least 3 months, with generalized pain in at least 4 of 5 body regions | The participants will report the outcome measures at baseline, after 3 and after 12 months. |
| Other questions | We will ask questions about sociodemographic factors, symptoms related to the condition, and how one lives with the condition. Additionally, medical record information regarding the current condition and comorbidity | The participants will report the outcome measures at baseline and after 12 months. |
| intention to reconsult and use of healthcare services | Intention to re-consult, use of health care services and use of medication will be elicited. The partisipant will report this in questionaires, and data will also be collected from national registers. | The participants will report the outcome measures at baseline and after 12 months |
| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014591 | Uterine Diseases |