Chronic PainattachpainNCT03845816
Evaluation of Attachment, Self-compassion and Coping Strategies in Chronic Pain Patients
An observational study of Chronic Pain, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Compare the self-compassionate score by type of attachment, "safe" or "insecure", in chronic pain patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Self-Compassion Scale (SCS) questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2018to 14 Jul 2021
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient newly treated at the pain center (i.e. any patient seen for the first time in a pain centre, and included in the research during one of the three medical consultations preliminary to overall management at the patient center)
Who may be able to join
- Chronic pain
Who cannot join
- Legal protection measure
- Patients followed for cancer
- Patients followed for multiple sclerosis
- Patients followed for Parkinson's disease
- Patients already followed in another CETD
- Decompensated psychiatric pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L'évaluation de l'Attachement, de l'Auto-compassion et Des stratégies de Coping Chez Les Patients Douloureux Chroniques
Compare the self-compassionate score by type of attachment, "safe" or "insecure", in chronic pain patients.
Read the detailed description
Attachment theory proposes a theoretical model that helps us explain how the process of developing interpersonal relationships can affect the search for care and the response of individuals to an illness.
Self-compassion is a concept developed by Kristin Neff. It refers to the disposition of each individual to contain their feelings of suffering by a feeling of warmth, connection and care.
The coping corresponds to the answers, the reactions, that the individual will develop to control, reduce or simply tolerate the aversive situation. Coping can take the form of cognitions, affects and behaviors that an individual will put in place to deal with a situation.
The three concepts (attachment, self-compassion, coping) seem to be interrelated, and they contribute to the explanation and management of chronic pain, in the spectrum of the bio-psycho-social model of pain. Yet no study has measured these three variables together in chronic pain patients
Chronic and Newly Assisted Patients at CETD (Neurosurgery Department, Pain Assessment and Treatment Center) (ie any patient seen for the first time in pain center, and included in the research during one of the three medical consultations preliminary to overall care at the CETD).
- Conditions
- Chronic Pain
- Being tested
- Self-Compassion Scale (SCS) questionnaire
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Compassion Scale (SCS) questionnaireBehavioural
all included patients with chronic pain will answer the Self-Compassion Scale (SCS) questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Compassion Quetionnaire
The self-compassion score level according to the Self-Compassion Scale Questionnaire (SCS).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start14 Dec 2018
- Primary completion14 Dec 2020
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845816
- Sponsor's protocol ID
- 2018-A01167-48
- Acronym
- attachpain
- Status last verified
- Jul 2021
- First submitted
- 18 Feb 2019
- Last updated
- 19 Jul 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'évaluation de l'Attachement, de l'Auto-compassion et Des stratégies de Coping Chez Les Patients Douloureux Chroniques
- ClinicalTrials.gov ID
- NCT03845816
- Acronym / sponsor ID
- attachpain / 2018-A01167-48
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 19 Feb 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.
Compare the self-compassionate score by type of attachment, "safe" or "insecure", in chronic pain patients.
Detailed description
Attachment theory proposes a theoretical model that helps us explain how the process of developing interpersonal relationships can affect the search for care and the response of individuals to an illness.
Self-compassion is a concept developed by Kristin Neff. It refers to the disposition of each individual to contain their feelings of suffering by a feeling of warmth, connection and care.
The coping corresponds to the answers, the reactions, that the individual will develop to control, reduce or simply tolerate the aversive situation. Coping can take the form of cognitions, affects and behaviors that an individual will put in place to deal with a situation.
The three concepts (attachment, self-compassion, coping) seem to be interrelated, and they contribute to the explanation and management of chronic pain, in the spectrum of the bio-psycho-social model of pain. Yet no study has measured these three variables together in chronic pain patients
Chronic and Newly Assisted Patients at CETD (Neurosurgery Department, Pain Assessment and Treatment Center) (ie any patient seen for the first time in pain center, and included in the research during one of the three medical consultations preliminary to overall care at the CETD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient newly treated at the pain center (i.e. any patient seen for the first time in a pain centre, and included in the research during one of the three medical consultations preliminary to overall management at the patient center)
Key inclusion criteria (1 listed)
- Chronic pain
Key exclusion criteria (6 listed)
- Legal protection measure
- Patients followed for cancer
- Patients followed for multiple sclerosis
- Patients followed for Parkinson's disease
- Patients already followed in another CETD
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 |
|---|---|---|
| Self-Compassion Scale (SCS) questionnaireall included patients with chronic pain will answer the Self-Compassion Scale (SCS) questionnaire | Behavioural | – |
Primary outcome
Self-Compassion Quetionnaire
Time frame: 1 month
The self-compassion score level according to the Self-Compassion Scale Questionnaire (SCS).
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 19 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Fondation Ophtalmologique Adolphe de Rothschild 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 1 inclusion and 6 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 19 Jul 2021. 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?
Self-Compassion Quetionnaire (time frame: 1 month). 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 19 Jul 2021.