EndometriosisEndoDOLNCT03993197
Endometriosis and Pain
A study testing Psychological and corporal group management in people with Endometriosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Endometriosis is a condition affecting about 10% of childbearing age women. It can begin a few months to a few years after puberty. It causes abdominal and pelvic pain that can be extremely debilitating, affecting the quality of patients life by affecting sexuality and fertility. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Psychological and corporal group management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2019to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >=18 years
- Patients with deep endometriosis according to the CNGOF (collège national des Gynécologues et Obstétriciens Français) and/or chronic pain related to endometriosis according to doctor's evaluation and to the definitions of IASP (International Association for the Study of Pain) and HAS (French National Authority for Health) in treatment failure despite appropriate medical or surgical management of endometriosis
- Patients with social security
- Patients willing to come to all study visits
- Patients who signed their informed consent
Who cannot join
- Patients unable to participate in group care:
- Patients with social phobia assessed during the inclusion interview
- Patients with psychiatric disorders of a psychotic nature: delirium, hallucination, incoherent thoughts
- Patients with behavioral disorders of hetero-aggressive or self-aggressive type oPatients with a handicap that prevents them following the physical and psychological group sessions (speech disorders, hearing, visual or practical)
- Pregnant women
- Patients planning a change (stop, start) during the study of their psychological management in their current care path.
Show all 12Show fewer
- Patients planning a change (stop, start) during the study of their treatment by non-medicinal techniques (auriculo-acupuncture, relaxation and self-hypnosis, transcutaneous neurostimulation by TENS)
- Patients suffering from other severe or chronic somatic diseases associated with endometriosis
- Patients with cognitive disorders
- Patients with analgesics addiction (psychoactive substances, morphine substances, etc.)
- Patients protected by law (under guardianship / trusteeship)
- Patients participating in another interventional research that may interfere with the protocol results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Perioperative and Non-pharmacological Practices in Endometriosis at the Crossroad of Gynecology and Chronic Pain
Endometriosis is a condition affecting about 10% of childbearing age women. It can begin a few months to a few years after puberty. It causes abdominal and pelvic pain that can be extremely debilitating, affecting the quality of patients life by affecting sexuality and fertility. Psychological repercussions are very important and underestimated. Patient care focuses most often on the "organ pathology treatment ".
This study proposes to evaluate a multidisciplinary patient care by insisting on anatomo-physiological pain management, psychological and bodily, in the perioperative phase.
The main objective is to evaluate benefit of psychological and corporal group management on the overall quality of life of patients with severe endometriosis in terms of endometriotic damage and/or functional and painful repercussions, requiring surgery, before or after this study
- Conditions
- Endometriosis
- Being tested
- Psychological and corporal group management
- Keywords
- Endometriosis, Pain, group management, quality of life
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological and corporal group managementBehavioural
After inclusion, patient will be divided into groups of 6 or 8 patients either in pre-operative or post-operative phase. Patient care will take place entirely in pre-operative or post-operative phase.
Each group will benefit of six one hour and a half sessions.
The frequency is established as follows:
- First week a session of Body Strategy ©
- Second week a psychological session with group of speech (Photolanguage ©).
- Third week is a break Then the cycle currently described is repeated, for a total of 6 alternate sessions
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from severe endometriosis and chronic pain | Experimental | Patients suffering from severe endometriosis and chronic pain that have been identified during a gynecological consultation (individual or during a multidisciplinary team meetings) or during a pain consultation on the same site of the Croix-Rousse Hospital and having signed a consent form Receives: Behavioral: Psychological and corporal group management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale
The Physical Composite Score (PCS) is based on four physical dimensions of quality of life and involves 8 components (Physical Functioning, Role Physical, Bodily Pain,General Health, Vitality, Social Functioning,Mental Health and Emotional Role). The evolution of the PCS is measured between T0, start of care, and the end of care (at T0 + 3 months).
The PCS score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Secondary outcomes (18)
Evolution of pain: Visual Analogue Scale (VAS)
Evolution of pain assessed by the Visual Analogue Scale (VAS) between the beginning (T0) and the end of patient care (T0 + 3 months), in different body areas (back - abdomen - pelvic area - others) The VAS allows patients to rate their pain in an objective and comparable measure. This allows a quantitative evaluation of intensity of pain and trace evolution of the symptomatology in the same subject.
The VAS ranges from 0 to 10, 0 for no pain, 10 for maximum pain.
Measured: at 3 months
Evolution of overall pain: Visual Analogue Scale (VAS)
Evolution of overall pain assessed by the Visual Analogue Scale (VAS) between the beginning (T0) and the end of patient care (T0 + 3 months) The VAS allows patients to rate their pain in an objective and comparable measure. This allows a quantitative evaluation of intensity of pain and trace evolution of the symptomatology in the same subject.
The VAS ranges from 0 to 10, 0 for no pain, 10 for maximum pain.
Measured: at 3 months
Comparison of painful location on the body pain schema, before/after patient care
Comparison of painful location (circle by the patient on the body schema) before (T0)/after patient care (T0 + 3 months).
Since endometriosis is synonymous with chronic and specific chronic pain (dyspareunia, dyschesia, cystalgia, for example), the body pain schema is a complementary tool in measurements, where the patient precisely surrounds the painful location (localizations of pain) and their extensions on a body schema,
Measured: at 3 months
Comparison of area of pain on the body pain schema, before/after patient care
Comparison of area of pain (circle by the patient on the body schema), before (T0)/after patient care (T0 + 3 months).
Area of each pain location will be calculated using the Geocalcul.Plus software and will be compared between the beginning (T0) and the end of patient care (T0 + 3 months).
Measured: at 3 months
Comparison of results of the interview schedule
Comparison of results of the interview schedule before (T0) and after patient care (T0 + 3 months). Interview schedule examines two dimensions :
- Inter-individual: couple quality of life, sex life
- Intra-individual: self-image/body image, infertility, emotional life, pre or postoperative felt
Measured: at 3 months
Evolution of analgesics consumption
Consumption of analgesics at the end of the treatment (T0 + 3 months) is self-evaluated by the patient: decreased / stable / increased.
Measured: at 3 months
number of painful crises
Number of painful crises is the comparison of seizures number in the month preceding treatment with seizures number in the last month of care
Measured: at 3 months
Evolution of the Vitality (VT) score of the MOS SF36 score, before/after treatment
The evolution of the Vitality (VT) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The VT score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evolution of the Social Function (SF) score of the MOS SF36 score, before/after treatment
The evolution of the Social Function (SF) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The SF score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evolution of the Mental Health (MH) score of the MOS SF36 score, before/after treatment
The evolution of the Mental Health (MH) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The MH score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evolution of the Role Emotional (RE) score of the MOS SF36 score, before/after treatment
The evolution of the Role Emotional (RE) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The RE score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evolution of the Physical Function (PF) score of the MOS SF36 score, before/after treatment
The evolution of the Physical Function (PF) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The PF score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evolution of the Role Physical (RP) score of the MOS SF36 score, before/after treatment
The evolution of the Role Physical (RP) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The RP score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evolution of the Bodily Pain (BP) score of the MOS SF36 score, before/after treatment
The evolution of the Bodily Pain (BP) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The BP score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evolution of the General Health (GH) score of the MOS SF36 score, before/after treatment
The evolution of the General Health (GH) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The GH score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evolution of the Health Thinking (HT) score of the MOS SF36 score, before/after treatment
The evolution of the Health Thinking (HT) score is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The HT score ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evolution of the Mental Component Score (MCS) of the MOS SF36 score, before/after treatment
The evolution of the Mental Component Score (MCS) is determined by the MOS SF36 and measured between T0, start of care, and the end of care (at T0 + 3 months).
The MCS ranges from 0 to 100, a higher score being associated with a better quality of life.
Measured: at 3 months
Evaluation of the patient compliance with group management sessions
The collection of the number of group sessions performed by the patient allows assessment of patient compliance with group management sessions. This evaluation allows to assess potential biases due to poor compliance in the final analysis.
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start11 Dec 2019
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Branche, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993197
- Sponsor's protocol ID
- 69HCL18_0474
- Other IDs
- 2018-A02599-46
- Acronym
- EndoDOL
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2019
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Perioperative and Non-pharmacological Practices in Endometriosis at the Crossroad of Gynecology and Chronic Pain
- ClinicalTrials.gov ID
- NCT03993197
- Acronym / sponsor ID
- EndoDOL / 69HCL18_0474
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Pain, group management, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endometriosis is a condition affecting about 10% of childbearing age women. It can begin a few months to a few years after puberty. It causes abdominal and pelvic pain that can be extremely debilitating, affecting the quality of patients life by affecting sexuality and fertility. Psychological repercussions are very important and underestimated. Patient care focuses most often on the "organ pathology treatment ".
This study proposes to evaluate a multidisciplinary patient care by insisting on anatomo-physiological pain management, psychological and bodily, in the perioperative phase.
The main objective is to evaluate benefit of psychological and corporal group management on the overall quality of life of patients with severe endometriosis in terms of endometriotic damage and/or functional and painful repercussions, requiring surgery, before or after this study
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from severe endometriosis and chronic pain | Experimental | Behavioral: Psychological and corporal group managementPatients suffering from severe endometriosis and chronic pain that have been identified during a gynecological consultation (individual or during a multidisciplinary team meetings) or during a pain consultation on the same site of the Croix-Rousse Hospital and having signed a consent form |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients >=18 years
- Patients with deep endometriosis according to the CNGOF (collège national des Gynécologues et Obstétriciens Français) and/or chronic pain related to endometriosis according to doctor's evaluation and to the definitions of IASP (International Association for the Study of Pain) and HAS (French National Authority for Health) in treatment failure despite appropriate medical or surgical management of endometriosis
- Patients with social security
- Patients willing to come to all study visits
- Patients who signed their informed consent
Key exclusion criteria (12 listed)
- Patients unable to participate in group care:
- Pregnant women
- Patients planning a change (stop, start) during the study of their psychological management in their current care path.
- Patients planning a change (stop, start) during the study of their treatment by non-medicinal techniques (auriculo-acupuncture, relaxation and self-hypnosis, transcutaneous neurostimulation by TENS)
- Patients suffering from other severe or chronic somatic diseases associated with endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological and corporal group managementAfter inclusion, patient will be divided into groups of 6 or 8 patients either in pre-operative or post-operative phase. Patient care will take place entirely in pre-operative or post-operative phase. Each group will benefit of six one hour and a half sessions. The frequency is established as follows: * First week a session of Body Strategy © * Second week a psychological session with group of speech (Photolanguage ©). * Third week is a break Then the cycle currently described is repeated, for a total of 6 alternate sessions | Behavioural | Patients suffering from severe endometriosis and chronic pain |
Primary outcome
Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale
Time frame: at 3 months
The Physical Composite Score (PCS) is based on four physical dimensions of quality of life and involves 8 components (Physical Functioning, Role Physical, Bodily Pain,General Health, Vitality, Social Functioning,Mental Health and Emotional Role). The evolution of the PCS is measured between T0, start of care, and the end of care (at T0 + 3 months). The PCS score ranges from 0 to 100, a higher score being associated with a better quality of life.
18 secondary outcomes
Evolution of pain: Visual Analogue Scale (VAS)
Time frame: at 3 months
Evolution of overall pain: Visual Analogue Scale (VAS)
Time frame: at 3 months
Comparison of painful location on the body pain schema, before/after patient care
Time frame: at 3 months
Comparison of area of pain on the body pain schema, before/after patient care
Time frame: at 3 months
Comparison of results of the interview schedule
Time frame: at 3 months
Evolution of analgesics consumption
Time frame: at 3 months
number of painful crises
Time frame: at 3 months
Evolution of the Vitality (VT) score of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evolution of the Social Function (SF) score of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evolution of the Mental Health (MH) score of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evolution of the Role Emotional (RE) score of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evolution of the Physical Function (PF) score of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evolution of the Role Physical (RP) score of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evolution of the Bodily Pain (BP) score of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evolution of the General Health (GH) score of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evolution of the Health Thinking (HT) score of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evolution of the Mental Component Score (MCS) of the MOS SF36 score, before/after treatment
Time frame: at 3 months
Evaluation of the patient compliance with group management sessions
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Branche, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological and corporal group management in people with Endometriosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.