NCT06617767

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 26, 2024

Last Update Submit

September 26, 2024

Conditions

Keywords

Diabetes MellitusReikiwell-Beinghappinessmetabolic control

Outcome Measures

Primary Outcomes (2)

  • Subjective Well-Being

    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.

    3 months

  • Happiness

    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.

    3 months

Secondary Outcomes (8)

  • HbA1c (%)

    3 months

  • Fasting blood glucose level (mg/dL)

    3 months

  • Postprandial blood glucose levels (mg/dl)

    3 months

  • Body mass index (kg/m2)

    3 months

  • LDL-kolesterol (mg/dL)

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Reiki

EXPERIMENTAL

The Reiki group received 20 minutes of remote Reiki once a day for 4 consecutive days

Other: Reiki

Control

NO INTERVENTION

No intervention was applied to the control group

Interventions

ReikiOTHER

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.

Reiki

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yüce

Osmaniye, 80000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were told that there were intervention and control groups in the study, but it was not explained which group they were in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Single-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 26, 2024

First Posted

September 27, 2024

Study Start

August 3, 2022

Primary Completion

February 3, 2023

Study Completion

July 31, 2024

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations