NCT05704465

Brief Summary

Diabetes is a worldwide chronic disease due to a disorder in the metabolism of blood glucose. It has high prevalence rates especially in developing countries and is associated with 1.5 million deaths per year. It showed increasing trends over the last few decades. This study aims to To evaluate and compare the effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients' negative emotional states. This open-label randomized controlled trial. The study was conducted at the National Institute of Diabetes and Endocrinology's Hospital. The study sampling population consisted of all patients suffering from Type 2 diabetes attending the setting during the time of the study. randomized into two equal groups: one group will receive reiki intervention, and a second group will receive the qi-gong intervention. The researcher will use a self-administered questionnaire with a standardized tool (Depression Anxiety Stress Scales \[DASS\]) for assessment of depression, anxiety, and stress, along with a section for patients' demographic and health characteristics such as age, gender, marital status, duration of diabetes, treatment modalities, body mass index, and glycemic control.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 9, 2023

Last Update Submit

January 28, 2023

Conditions

Keywords

Reiki therapyQi-gong therapyType-2 Diabetic

Outcome Measures

Primary Outcomes (1)

  • effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients' negative emotional states.

    The response to each statement is on a 4-point scale ranging from "Do not apply to me at all" to "Applies to me very much, or most of the time." These are scored from zero to three, respectively. The total score for each of the three dimensions is computed by simple summation of the scores of its fourteen statements. A higher score of the anxiety dimension denotes that the respondent is apprehensive, shaky, may experience sweating of palms, breathing difficulties, and tachycardia, with possible loss of control

    8 months

Study Arms (2)

Reiki Therapy

OTHER

Reiki is a biofield therapy technique based on energy healing.

Behavioral: Reiki Therapy

Qi-gong Therapy

OTHER

Qigong technique is a type of mind-body meditative exercise developed in traditional Chinese medicine more than 5000 years ago.

Behavioral: Qi-gong Therapy

Interventions

Reiki TherapyBEHAVIORAL

Reiki therapy involved 3 theoretical sessions, 4 practical sessions, and one final one for recapitulation and evaluation. In this technique, energy is guided by therapist's hands placed near patient's body to activate the ability of the body to heal and restore its balance. 1st session for explanation of aim and objectives of program. 2nd one focused on knowledge about negative emotional state. 3rd one discussed Reiki technique and its concept, mode of action, and process. The 4th through 7th sessions were practical. During these sessions, a Reiki practitioner moves his/her hands close to the patient's body in a set of positions. Each hand position focuses on a different part of the body. The hands are held in position for 3 to 10 min., depending on patient's needs. By the end of the session, the patient and therapist reflect on their experience and the emotions with the technique. The eighth session was a recapitulation of the program and ended with evaluation or post-testing.

Reiki Therapy
Qi-gong TherapyBEHAVIORAL

Qi-gong involved 3 theoretical sessions, 4 practical sessions, and one final one for recapitulation and evaluation. It involves coordination of breathing and physical movement with mental energy to promote cognitive performance. Both 1st and 2nd sessions were similar to Reiki technique group. The 3rd one addressed the concept of Qi-gong therapy. The 4th through 7th sessions involved patients' doing simple movements and breathing techniques. The practitioner is at about a one-foot distance from the patient's body, to guide and manipulate movements. Breathing patterns are like yoga, with Qigong movements in a mindful link to inspiration and expiration, with incorporation of deep diaphragmatic breathing. The 8th session was similarly for program recapitulation and post-testing.

Qi-gong Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes with unchanged antidiabetic therapy Type 2 diabetes with negative emotional state (depression, anxiety, stress)

You may not qualify if:

  • Patients with severe psychiatric Patients with neurological disability or addiction, Patients who unable to perform the intervention techniques Patients who enrolled in other clinical trials were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Institute of Diabetes and Endocrinology's Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Therapeutic Touch

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatric and Mental Health Nursing

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 30, 2023

Study Start

June 1, 2022

Primary Completion

January 20, 2023

Study Completion

August 1, 2024

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations