Reiki and Qi-gong Therapy to Improve Negative Emotional States of Anxiety, Depression, and Stress in Type-2 Diabetics

Reiki and Qi-gong Therapy Techniques in Improving Negative Emotional States of Anxiety, Depression, and Stress Among Type-2 Diabetic Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Type-2 Diabetic Patients
• Intervention / Treatment: Behavioral: Reiki and Qi-gong Therapy

Detailed Description

Rationale & background information:

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 (WHO, 2020). Egypt has high prevalence rates of diabetes reaching 20.9% among 20-79 years old, and it ranks tenth highest country in the global ranking of age-adjusted DM prevalence (Sayed Ahmed et al., 2022).

Type-1 diabetes mellitus (T1DM) is attributed autoimmune destruction of the β-cells of the pancreas which are responsible for insulin secretion. Meanwhile, in Type-2 diabetes mellitus (T2DM), which is the more prevalent, patients suffer from insulin resistance. These two types are widely different in their etiology, epidemiology, complications, and prognosis although some cases may pose some ambiguity in diagnosis (Laspe et al., 2022).

Diabetic patients may on the long-term suffer low quality of life due to its physical and psychological complications attributed to macro- and micro-vascular changes leading to renal, retinal, peripheral vascular, cardiovascular, and neurological diseases (Ali et al., 2022). Moreover, their risk of death diabetic patients is 1.5 times higher than the general population. Yet, the advances in the treatment modalities of diabetes with the new technologies led to improvements in the life expectancy and prevention of complications among these patients (Kulzer, 2022).

In addition to the physical complications associated with Type-2 DM, these patients are at high risk of suffering a wide spectrum of psychological disorders. Thus, diabetic patients are more likely to have negative emotions such as anxiety, depression, and stress (Khashayar et al., 2022). Research has demonstrated high prevalence rates of these psychological problems among diabetic patients (Al-Mohaimeed, 2017; Alajmani et al., 2019; Alzahrani et al., 2019). The association between these negative emotion symptoms and diabetes and its trajectory seem to be complicated and bidirectional (Cárdenas et al., 2022). For instance, stress and anxiety can increase the risk of developing Type-2 DM through its deregulatory effect on the hypothalamic-pituitary-adrenal axis, thus initiating resistance to insulin (Merswolken et al., 2012). Moreover, depression among was shown to increase the risk of diabetic retinopathy among diabetic patients (Sun et al., 2022).

The management of Type-2 DM has greatly evolved during the last few decades, with technological advances reflected on its treatment modalities including self-monitoring, precise insulin titration, and insulin pump, and smart insulin pens (Simmons and Riddley, 2022). Added to these are the advances in pharmacotherapy (Kobayati et al., 2022), telehealth (Kasturiratne et al., 2022), and mobile applications (Lee et al., 2022).

Complementary and alternative medicine have also added to the effectiveness of treatments of Type-2 DM, and research demonstrated better patient outcomes in multi-approaches compared to mono-approaches in its management (Alanazi et al., 2022). Reflexology, which is based on application of pressure on hands and feet is one of these approaches (Whatley et al., 2022). Reiki is a biofield therapy technique based on energy healing, developed by the Japanese Mikao Usui of Kyoto in the 19's. 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 (Zadro and Stapleton, 2022). It demonstrated successes in management of fatigue in breast cancer patients on chemotherapy (Karaman and Tan, 2021), sleep disorders (Costa et al., 2022), hypertension and alcohol consumption (Pérez Briones et a., 2022), children on palliative care (Thrane et al., 2022), and cerebral palsy (Love et al., 2022).

Meanwhile, Qigong technique is a type of mind-body meditative exercise developed in traditional Chinese medicine more than 5000 years ago. It involves coordination of breathing and physical movement with mental energy to promote cognitive performance (Chan et al., 2019; Zheng et al., 2020). It showed effectiveness in the management of patients with knee osteoarthritis (Chao et al., 2021), atrial fibrillation (Oesterle et al., 2022), pulmonary rehabilitation for COPD (Gauthier et al., 2022), and hypertension (Kohl-Heckl et al., 2022).

Significance of the study:

Diabetes mellitus represents a major public health problem in Egypt, with increasing trends. Although recognizing and addressing its related psychological symptoms is of great importance in its management, this still remains suboptimal. Inexpensive complementary medicine approaches like Reiki and Qi-gong therapies could be of help.

Study goals and objectives:

To evaluate and compare the effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients' negative emotional states.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nagwa A. Souilm; Phone Number: +2 01275662771; Email: nagwa.ahmed@nursing.bsu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • The National Institute of Diabetes and Endocrinology's Hospital
    • Contact: Phone Number: +2 0225351477; Email: nide@gothi.gov.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients will recruit in the study sample with the inclusion criteria of having Type 2 diabetes diagnosed based to ADA criteria, with unchanged antidiabetic therapy, and having a diagnosed negative emotional state (depression, anxiety, stress).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Reiki Therapy; Reiki is a biofield therapy technique based on energy healing, developed by the Japanese Mikao Usui of Kyoto in the 19's. 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 (Zadro and Stapleton, 2022). It demonstrated successes in management of fatigue in breast cancer patients on chemotherapy (Karaman and Tan, 2021), sleep disorders (Costa et al., 2022), hypertension and alcohol consumption (Pérez Briones et a., 2022), children on palliative care (Thrane et al., 2022), and cerebral palsy (Love et al., 2022).	Behavioral: Reiki and Qi-gong Therapy; The intervention program for each type of the two therapies involved three theoretical sessions for knowledge background about diabetes and negative emotional state, four practical sessions, and one final session for recapitulation and evaluation
Other: Qi-gong Therapy; Qigong technique is a type of mind-body meditative exercise developed in traditional Chinese medicine more than 5000 years ago. It involves coordination of breathing and physical movement with mental energy to promote cognitive performance (Chan et al., 2019; Zheng et al., 2020). It showed effectiveness in the management of patients with knee osteoarthritis (Chao et al., 2021), atrial fibrillation (Oesterle et al., 2022), pulmonary rehabilitation for COPD (Gauthier et al., 2022), and hypertension (Kohl-Heckl et al., 2022).	Behavioral: Reiki and Qi-gong Therapy; The intervention program for each type of the two therapies involved three theoretical sessions for knowledge background about diabetes and negative emotional state, four practical sessions, and one final session for recapitulation and evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 months

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): January 20, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Reiki therapy, Qi-gong therapy, Type-2 Diabetic
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: NSBS09012023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No