Viewing Study NCT05704465



Ignite Creation Date: 2024-05-06 @ 6:33 PM
Last Modification Date: 2024-10-26 @ 2:50 PM
Study NCT ID: NCT05704465
Status: RECRUITING
Last Update Posted: 2023-01-31
First Post: 2023-01-09

Brief Title: Reiki and Qi-gong Therapy to Improve Negative Emotional States of Anxiety Depression and Stress in Type-2 Diabetics
Sponsor: Beni-Suef University
Organization: Beni-Suef University

Study Overview

Official Title: Reiki and Qi-gong Therapy Techniques in Improving Negative Emotional States of Anxiety Depression and Stress Among Type-2 Diabetic Patients
Status: RECRUITING
Status Verified Date: 2023-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 15 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 Endocrinologys 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
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 15 million deaths per year It showed increasing trends over the last few decades Egypt has high prevalence rates of diabetes reaching 209 among 20-79 years old and it ranks tenth highest country in the global ranking of age-adjusted DM prevalence

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

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 Moreover their risk of death diabetic patients is 15 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

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 Research has demonstrated high prevalence rates of these psychological problems among diabetic patients The association between these negative emotion symptoms and diabetes and its trajectory seem to be complicated and bidirectional 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 Moreover depression among was shown to increase the risk of diabetic retinopathy among diabetic patients

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 Added to these are the advances in pharmacotherapy telehealth and mobile applications

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 Reflexology which is based on application of pressure on hands and feet is one of these approaches Reiki is a biofield therapy technique based on energy healing developed by the Japanese Mikao Usui of Kyoto in the 19s In this technique energy is guided by therapists hands placed near patients body to activate the ability of the body to heal and restore its balance It demonstrated successes in management of fatigue in breast cancer patients on chemotherapy sleep disorders hypertension and alcohol consumption children on palliative care and cerebral palsy

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 It showed effectiveness in the management of patients with knee osteoarthritis atrial fibrillation pulmonary rehabilitation for COPD and hypertension

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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None