Nctid:
NCT06227130
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000073397", "term"=>"Occupational Stress"}], "ancestors"=>[{"id"=>"D000009784", "term"=>"Occupational Diseases"}, {"id"=>"D000013315", "term"=>"Stress, Psychological"}, {"id"=>"D000001526", "term"=>"Behavioral Symptoms"}], "browseLeaves"=>[{"id"=>"M1167", "name"=>"Occupational Stress", "asFound"=>"Stress, Job", "relevance"=>"HIGH"}, {"id"=>"M12719", "name"=>"Occupational Diseases", "relevance"=>"LOW"}, {"id"=>"M16105", "name"=>"Stress, Psychological", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Occupational Diseases", "abbrev"=>"BC24"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"HEALTH_SERVICES_RESEARCH", "interventionModel"=>"CROSSOVER", "interventionModelDescription"=>"Intervention group (IG) and waiting group (WG). IG will start with intervention program. After 6 weeks WG does the intervention program. PSS-questionnaire will be performed at baseline and after 6 weeks for both groups, and after 12 weeks for WG."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2024-04-02", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-07-04", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-08", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"PSS14", "timeFrame"=>"12 weeks", "description"=>"Self perceived stress According till PSS 14"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["yoga", "mindfulness", "meditation"], "conditions"=>["Stress, Job"]}, "descriptionModule"=>{"briefSummary"=>"General practitioners perceive their work as meaningful. However, according to a report from the Swedish Medical Association in 2022, about a quarter had considered leaving the profession altogether and nearly half had considered changing workplaces or reducing their working hours during the past 12 months. Several studies on mindfulness, yoga and meditation have shown effect on stress and burn out symptoms. The aim of the study is to investigate whether a specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work, can reduce perceived stress levels compared to a control group.", "detailedDescription"=>"The study is designed as a randomized controlled trial with a crossover design. The outcome measure is the level of stress assessed using the Perceived Stress Scale (PPS), Swedish version (PSS 14). Inclusion criteria are resident general practitioners in Skåne, within the preliminary catchment area of Malmö Trelleborg, who have experienced any form of stress symptoms they believe are related to their work. Participants will be recruited through an oral presentation during an educational seminar in spring 2024. Those who are interested will get a link to a webb-based questionnaire where they can fill in their informed consent and contact information. Participants will be randomised to intervention (I) or waiting list (C). The interventions lasts for 6 weeks and consists of a 6 different mindfulness/ meditation/yoga-sessions (lasting for 20 minutes each). The sessions will be sent to the participant on USB-stick or via webb-link. Each of the 6 sessions are tailored to address a specific challenge that resident doctors may face in their daily work. The preliminary themes that will be addressed are 'Handling Mistakes,' 'Letting Go of Work,' 'Setting Boundaries,' 'Taking Breaks,' 'Being Good Enough,' and 'Managing Work Stress. The participants are encouraged to perform the program at least 3 times/week. Both groups will fill in the PSS-questionnaire at study start and after 6 weeks.\n\nThe control group will start the intervention after the second questionnaire (week 7-12) and will fill out the PSS-questionnaire a third time after intervention completion. The results will be analysed according to intention to treat. The Mann-Whitney U-test will be used to compare whether there is a significant difference in the change of median values on PSS 14 between the intervention and control groups."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Resident doctor in primary care having felt work related stress at any time\n\nExclusion Criteria:\n\n* none"}, "identificationModule"=>{"nctId"=>"NCT06227130", "acronym"=>"MindYou", "briefTitle"=>"Meditation, Mindfulness, and Yoga to Reduce Perceived Stress in Resident Doctors - A Randomized Controlled Trial With Crossover Design", "organization"=>{"class"=>"OTHER", "fullName"=>"Region Skane"}, "officialTitle"=>"Does a 6-week Specially Designed Meditation, Mindfulness, and Yoga Program Reduce Perceived Stress in Resident General Practitioners? - A Randomized Controlled Trial With Crossover Design.", "orgStudyIdInfo"=>{"id"=>"Dnr 2023-05678-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Intervention", "description"=>"Experimental: Intervention A specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work. Each session lasts for about 20 minutes and the participant is encouraged to perform the session at least 3 times/week.", "interventionNames"=>["Behavioral: MindYou"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Waiting list", "description"=>"The first 6 weeks of the study, the participants will be controls. During week 6-12 they will then perform the intervention according to the description above.", "interventionNames"=>["Behavioral: MindYou"]}], "interventions"=>[{"name"=>"MindYou", "type"=>"BEHAVIORAL", "description"=>"A specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work.", "armGroupLabels"=>["Intervention", "Waiting list"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Lund", "country"=>"Sweden", "facility"=>"Educational Meeting for Resident Physicians in Lund", "geoPoint"=>{"lat"=>55.70584, "lon"=>13.19321}}, {"city"=>"Malmö", "country"=>"Sweden", "facility"=>"Educational Meeting for Resident Physicians in Malmö", "geoPoint"=>{"lat"=>55.60587, "lon"=>13.00073}}], "overallOfficials"=>[{"name"=>"Moa Wolff", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Lund University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Region Skane", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
