Type-2 Diabetic PatientsNCT05704465
Reiki and Qi-gong Therapy to Improve Negative Emotional States of Anxiety, Depression, and Stress in Type-2 Diabetics
A study testing Reiki Therapy and Qi-gong Therapy in people with Type-2 Diabetic Patients, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type-2 Diabetic Patients
- What is being tested?
- Reiki Therapy and Qi-gong Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetes with unchanged antidiabetic therapy Type 2 diabetes with negative emotional state (depression, anxiety, stress)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
The National Institute of Diabetes and Endocrinology's Hospital
Cairo
0225351477 ext. +2, nide@gothi.gov.eg
About this study
Official title: 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.
Read the 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. 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.
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 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.
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 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. 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.
- Conditions
- Type-2 Diabetic Patients
- Being tested
- Reiki Therapy, Qi-gong Therapy
- Keywords
- Reiki therapy, Qi-gong therapy, Type-2 Diabetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki TherapyBehavioural
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.
Qi-gong TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reiki Therapy | Other | Reiki is a biofield therapy technique based on energy healing. Receives: 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. Receives: Behavioral: Qi-gong Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Jun 2022
- Primary completion20 Jan 2023
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-2 Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagwa Souilm, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704465
- Sponsor's protocol ID
- NSBS09012023
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reiki and Qi-gong Therapy Techniques in Improving Negative Emotional States of Anxiety, Depression, and Stress Among Type-2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT05704465
- Acronym / sponsor ID
- NSBS09012023
- Conditions
- Type-2 Diabetic Patients
- Keywords
- Reiki therapy, Qi-gong therapy, Type-2 Diabetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- Aug 2024 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
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 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.
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 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. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reiki Therapy | Other | Behavioral: Reiki TherapyReiki is a biofield therapy technique based on energy healing. |
| Qi-gong Therapy | Other | Behavioral: Qi-gong TherapyQigong technique is a type of mind-body meditative exercise developed in traditional Chinese medicine more than 5000 years ago. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes with unchanged antidiabetic therapy Type 2 diabetes with negative emotional state (depression, anxiety, stress)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiki TherapyReiki 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. | Behavioural | Reiki Therapy |
| Qi-gong TherapyQi-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. | Behavioural | Qi-gong Therapy |
Primary outcome
effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients' negative emotional states.
Time frame: 8 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki Therapy and Qi-gong Therapy in people with Type-2 Diabetic Patients, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nagwa A. Souilm (01275662771 ext. +2, nagwa.ahmed@nursing.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients' negative emotional states. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.