Nctid:
NCT06617767
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000003924", "term"=>"Diabetes Mellitus, Type 2"}], "ancestors"=>[{"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "asFound"=>"Diabetes Mellitus, Type 2", "relevance"=>"HIGH"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "asFound"=>"Diabetes Mellitus", "relevance"=>"HIGH"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"], "maskingDescription"=>"Participants were told that there were intervention and control groups in the study, but it was not explained which group they were in."}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Single-blind randomized controlled trial"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>61}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-08-03", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-07-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-26", "studyFirstSubmitDate"=>"2024-09-26", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-02-03", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Subjective Well-Being", "timeFrame"=>"3 months", "description"=>"The Subjective Well-Being Scale is a measurement tool developed to determine the subjective experiences and vitality levels of individuals in terms of feeling lively, energetic and alert, and is based on individuals providing information about themselves. The seven-item, 7-point Likert-type scale is ranked from 1 (Does not apply to me at all) to 7 (Completely applies to me), and participants are asked to determine the extent to which they agree with the statement in each item. The scores of all items in the scale can be added to obtain the individual's total subjective vitality score. The range of scores on the scale varies between 7 and 49. High scores on the scale indicate that the individual has a high level of subjective vitality.It is expected that the scores that the participants receive from this scale will increase in the final measurement."}, {"measure"=>"Happiness", "timeFrame"=>"3 months", "description"=>"OXFORD Happiness scale is a 29-item, 6-point Likert-type scale (1-I completely disagree, 6-I completely agree) developed to measure happiness. A high score obtained from the scale indicates an increase in the level of happiness. The scale score range varies between 29-174. It is expected that the scores that the participants receive from this scale will increase in the final measurement."}], "secondaryOutcomes"=>[{"measure"=>"HbA1c (%)", "timeFrame"=>"3 months", "description"=>"HbA1c, is the main biomarker used to assess long-term glycaemic control in individuals with diabetes.In the final test, this value was targeted to be below the level recorded in the pre test in Reiki gruop."}, {"measure"=>"Fasting blood glucose level (mg/dL)", "timeFrame"=>"3 months", "description"=>"Fasting blood glucose level is the level of glucose in the blood measured after at least 8 hours of overnight fasting.In the final test, this value was targeted to be below the level recorded in the pre test."}, {"measure"=>"Postprandial blood glucose levels (mg/dl)", "timeFrame"=>"3 months", "description"=>"Postprandial blood sugar is the blood sugar level measured 2 hours after food intake (first bite). It should not be over 140 mg/dl.In the final test, this value was targeted to be below the level recorded in the first test."}, {"measure"=>"Body mass index (kg/m2)", "timeFrame"=>"3 months", "description"=>"The study initially included individuals who were overweight or obese (BMI ≥ 25kg/m²). The aim was to reduce the body mass index of the participants in the Reiki group, measured in the post-test."}, {"measure"=>"LDL-kolesterol (mg/dL)", "timeFrame"=>"3 months", "description"=>"The highest LDL (low density lipoprotein) level in the post-test measurements of individuals in the Reiki group was targeted to be 130 mg/dL."}, {"measure"=>"HDL-kolesterol (mg/dL)", "timeFrame"=>"3 months", "description"=>"The lowest HDL (high density lipoprotein) level in the post-test measurements of individuals in the Reiki group was targeted to be 40 mg/dL for women and 50 mg/dL for men."}, {"measure"=>"Total kolesterol (mg/dL)", "timeFrame"=>"3 months", "description"=>"The highest total kolesterol level in the post-test measurements of individuals in the Reiki group was targeted to be 200 mg/dL."}, {"measure"=>"Triglyceride levels (mg/dL)", "timeFrame"=>"3 months", "description"=>"The highest triglyceride level in the post-test measurements of individuals in the Reiki group was targeted to be 150 mg/dL."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Diabetes Mellitus", "Reiki", "well-Being", "happiness", "metabolic control"], "conditions"=>["Diabetes Mellitus, Type 2"]}, "descriptionModule"=>{"briefSummary"=>"Aim: To evaluate the effects of Reiki on subjective well-being, happiness, and some metabolic variables in patients with Type-II diabetes.", "detailedDescription"=>"This study, designed as a randomized controlled trial with a pretest-posttest design, was conducted between September 2022 and August 2023 at the Internal Medicine clinic of Kanuni Sultan Süleyman Training and Research Hospital, Istanbul Provincial Health Directorate. The participants were voluntary individuals who had been diagnosed with Type-II Diabetes Mellitus at least 6 months prior, had a BMI ≥ 25kg/m² (overweight or obese), HbA1c ≥ 6.5%, were following a diabetes-specific diet or using oral antidiabetics, and were neither Reiki practitioners nor instructors. Randomization was used to assign participants to either the Reiki group or the control group. During the pretest, participants were asked to complete the Personal Information Form, the Subjective Well-Being Scale (SWS), and the OXFORD Happiness Scale (OHS). Pre-intervention fasting and postprandial blood glucose levels, HbA1c percentage, body mass index, LDL-HDL/total cholesterol, triglyceride levels, and blood pressure measurements were obtained from the patients' records and documented.The Reiki group received 20 minutes of remote Reiki once a day for 4 consecutive days, while no intervention was applied to the control group. The Subjective Well-Being Scale and OXFORD Happiness Scale were reapplied to both groups at the first and second months following the intervention, and the metabolic values, along with these scales, were measured again in the third month."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Diagnosed with Type-II Diabetes Mellitus at least 6 months prior\n* Had a BMI ≥ 25kg/m² (overweight or obese)\n* HbA1c ≥ 6.5%\n\nExclusion Criteria:\n\n* Being diagnosed with another disease and needing treatment during the data collection process\n* Being a Reiki practitioner or instructor\n* Using insulin for treatment"}, "identificationModule"=>{"nctId"=>"NCT06617767", "briefTitle"=>"The Effect of Reiki in Patients With Type-II Diabetes", "organization"=>{"class"=>"OTHER", "fullName"=>"Osmaniye Korkut Ata University"}, "officialTitle"=>"The Effect of Reiki on Subjective Well-being, Happiness, and Some Metabolic Variables in Patients With Type-II Diabetes: Single-blind Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"2022/5/2"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Reiki", "description"=>"The Reiki group received 20 minutes of remote Reiki once a day for 4 consecutive days", "interventionNames"=>["Other: Reiki"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control", "description"=>"No intervention was applied to the control group"}], "interventions"=>[{"name"=>"Reiki", "type"=>"OTHER", "description"=>"The Reiki group received distant Reiki application to their energy centers for 20 minutes, once a day, for 4 consecutive days, by researchers with Reiki Stage II training under the guidance of a researcher with the Usui Reiki Master \\& Teacher degree.", "armGroupLabels"=>["Reiki"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"80000", "city"=>"Osmaniye", "country"=>"Turkey", "facility"=>"Yüce", "geoPoint"=>{"lat"=>37.07417, "lon"=>36.24778}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Osmaniye Korkut Ata University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor", "investigatorFullName"=>"Ulviye Özcan Yüce", "investigatorAffiliation"=>"Osmaniye Korkut Ata University"}}}}
