Clinical trial NCT06617767: The Effect of Reiki in Patients With Type-II Diabetes
Official title: The Effect of Reiki on Subjective Well-being, Happiness, and Some Metabolic Variables in Patients With Type-II Diabetes: Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Reiki
well-Being
happiness
metabolic control
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: To evaluate the effects of Reiki on subjective well-being, happiness, and some metabolic variables in patients with Type-II diabetes.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Type-II Diabetes Mellitus at least 6 months prior
* Had a BMI ≥ 25kg/m² (overweight or obese)
* HbA1c ≥ 6.5%

Exclusion Criteria:

* Being diagnosed with another disease and needing treatment during the data collection process
* Being a Reiki practitioner or instructor
* Using insulin for treatment

Primary outcomes:
measure: Subjective Well-Being
timeFrame: 3 months
measure: Happiness
timeFrame: 3 months
Secondary outcomes:
measure: HbA1c (%)
timeFrame: 3 months
measure: Fasting blood glucose level (mg/dL)
timeFrame: 3 months
measure: Postprandial blood glucose levels (mg/dl)
timeFrame: 3 months
measure: Body mass index (kg/m2)
timeFrame: 3 months
measure: LDL-kolesterol (mg/dL)
timeFrame: 3 months
measure: HDL-kolesterol (mg/dL)
timeFrame: 3 months
measure: Total kolesterol (mg/dL)
timeFrame: 3 months
measure: Triglyceride levels (mg/dL)
timeFrame: 3 months
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Yüce
Study officials:
References: