protocolSection identificationModule nctId: NCT06279650, orgStudyIdInfo id: 2022-2741, briefTitle: Self-hypnosis Training for Chronic Pain Management, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ciusss de L'Est de l'Île de Montréal, class: OTHER, descriptionModule briefSummary: Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada.Adverse events: none expected., conditionsModule conditions: Hypnosis, Chronic Pain Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Self-hypnosis, interventions name: Psycho-education and cognitive Bahavioral therapy (CBT), outcomesModule primaryOutcomes measure: Time 1 : Numerical Rating Scale (NRS) from 0 to 10, primaryOutcomes measure: Time 1 : Questionnaire Brief Pain Inventory (BPI), primaryOutcomes measure: Time 1 : Hospital anxiety and depression scale (HADS), primaryOutcomes measure: Time 1 : SF-36 (36-Item Short Form Survey), primaryOutcomes measure: Time 1 : Questionnaire socio-demographic and clinical, secondaryOutcomes measure: Time 2 : Numerical Rating Scale (NRS) from 0 to 10, secondaryOutcomes measure: Time 2 : Questionnaire Brief Pain Inventory (BPI), secondaryOutcomes measure: Time 2 : Hospital anxiety and depression scale (HADS), secondaryOutcomes measure: Time 2 : SF-36 (36-Item Short Form Survey), otherOutcomes measure: Time 3 : Numerical Rating Scale (NRS) from 0 to 10, otherOutcomes measure: Time 3 : Questionnaire Brief Pain Inventory (BPI), otherOutcomes measure: Time 3 : Hospital anxiety and depression scale (HADS), otherOutcomes measure: Time 3 : SF-36 (36-Item Short Form Survey), otherOutcomes measure: Time 4 : Numerical Rating Scale (NRS) from 0 to 10, otherOutcomes measure: Time 4 : Questionnaire Brief Pain Inventory (BPI), otherOutcomes measure: Time 4 : Hospital anxiety and depression scale (HADS), otherOutcomes measure: Time 4 : SF-36 (36-Item Short Form Survey), otherOutcomes measure: Time 5 : Numerical Rating Scale (NRS) from 0 to 10, otherOutcomes measure: Time 5 : Questionnaire Brief Pain Inventory (BPI), otherOutcomes measure: Time 5 : Hospital anxiety and depression scale (HADS), otherOutcomes measure: Time 5 : SF-36 (36-Item Short Form Survey), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 5415 Bd de l'Assomption, status: RECRUITING, city: Montréal, state: Quebec, zip: H1T 2M4, country: Canada, contacts name: David Ogez, role: CONTACT, email: david.ogez@umontreal.ca, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False