Diabetes Mellitus Type 2 in ObeseNCT05942079
"The Effect of Reiki on Metabolic Parameters in Obese Type 2 Diabetes Patients''
An observational study of Diabetes Mellitus Type 2 in Obese, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
Trial summary
The increase in the prevalence of diabetes and the loss of various organs and functions in the individual as a result of complications caused by diabetes affect the life expectancy and quality of individuals, and cause social and economic losses affecting the whole society. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2 in Obese
- What is being tested?
- REİKİ
- How many people
- 1 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 1 Nov 2023
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Having been diagnosed with Type 2 diabetes at least 6 months ago, Body mass index ≥ 30 kg/m², Being on oral therapy or using insulin
Who may be able to join
- Having been diagnosed with Type 2 diabetes at least 6 months ago,
- Body mass index ≥ 30 kg/m²
- Being on oral therapy or using insulin,
- Ability to communicate and read,
- Volunteering to participate in research
Who cannot join
- Not complying with the principle of voluntarism
- Answering data collection forms incompletely
- Desire to leave the study at any stage of the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Harran unv.
Sanliurfa
Fatmaz Zehra KÜÇÜK
- Recruiting
Harran Unv
Sanliurfa
FATMAZ ZEHRA FZ KÜÇÜK, 1, 05327443029, zehraklc2015@gmail.com
About this study
Official title: The Effect of Reiki on Treatment Compliance, Eating Behaviors and Metabolic Values in Obese Individuals With Type 2 Diabetes": Randomized Controlled Study
The increase in the prevalence of diabetes and the loss of various organs and functions in the individual as a result of complications caused by diabetes affect the life expectancy and quality of individuals, and cause social and economic losses affecting the whole society. For this reason, the individual management of the diabetic patient is important in terms of ensuring effective participation and compliance in treatment and care. Patients must have knowledge, skills and positive attitudes in order to successfully comply with diabetes treatment. Patients are in compliance with diabetes treatment; they encounter some barriers such as medication barriers, barriers to self-monitoring, knowledge and belief barriers, barriers to diagnosis, barriers in relations with health professionals, barriers to lifestyle change, barriers to coping with diabetes, and barriers to getting advice and support. The American Diabetes Association (ADA) states that self-monitoring of blood sugar is important in ensuring glycemic control and preventing hyperglycemia and asymptomatic hypoglycemia. Reiki is applied as an alternative and complementary treatment method. Reiki application, when used together with pharmacological methods, chronic fatigue, diabetic neuropathy, pain caused by surgery, cancer treatment, symptoms of cardiovascular diseases, emotional disorders such as anxiety, depression, acute or chronic pain, infertility-related problems, neurodegenerative disorders, AIDS, autism and developmental disorders, Crohn's disease, irritable bowel syndrome, traumatic brain injury and has been shown to improve health problems such as fatigue.
In the literature, the effects of reiki have been examined in patient groups with different chronic diseases, but no study has been found on obese individuals with Type 2 diabetes. Therefore, reikinin in obese individuals with Type 2 diabetes; This study is planned to determine whether it has an effect on compliance with diabetes treatment, eating behaviors, anxiety levels and changes in metabolic values.
Read the detailed description
The increase in the prevalence of diabetes and the loss of various organs and functions in the individual as a result of complications caused by diabetes affect the life expectancy and quality of individuals, and cause social and economic losses affecting the whole society. Diabetes with poor management causes many acute and chronic complications. Keeping diabetes under control seriously affects the occurrence of microvascular and macrovascular complications, which develop over years and seriously affect life. Compliance with diabetes treatment; nutrition therapy, regular exercise program, patient self-monitoring, medication, access to health facilities and patient education. With regular monitoring and monitoring of these parameters, compliance with a successful diabetes treatment is improved. The basis of compliance with diabetes treatment is determined by the attitudes and behaviors of patients regarding their own health. For this reason, the individual management of the diabetic patient is important in terms of ensuring effective participation and compliance in treatment and care. Patients must have knowledge, skills and positive attitudes in order to successfully comply with diabetes treatment. Patients are in compliance with diabetes treatment; they encounter some barriers such as medication barriers, barriers to self-monitoring, knowledge and belief barriers, barriers to diagnosis, barriers in relations with health professionals, barriers to lifestyle change, barriers to coping with diabetes, and barriers to getting advice and support. The inability of the individual to cope with these obstacles adequately causes problems in compliance with diabetes treatment. One of the most important points in compliance with diabetes management and treatment is self-monitoring of blood glucose. The American Diabetes Association (ADA) states that self-monitoring of blood sugar is important in ensuring glycemic control and preventing hyperglycemia and asymptomatic hypoglycemia. HbA1c levels were found to be lower in patients who measured their blood glucose more frequently. In patients with poor diabetes management and persistent hyperglycemia, there is an increase in HbA1c value. A 1% increase in HbA1c value is accepted as a risk in the formation of complications. Reiki is applied as an alternative and complementary treatment method. Reiki application, when used together with pharmacological methods, chronic fatigue, diabetic neuropathy, pain caused by surgery, cancer treatment, symptoms of cardiovascular diseases, emotional disorders such as anxiety, depression, acute or chronic pain, infertility-related problems, neurodegenerative disorders, AIDS, autism and developmental disorders, Crohn's disease, irritable bowel syndrome, traumatic brain injury and has been shown to improve health problems such as fatigue (43).
In the literature, the effects of reiki have been examined in patient groups with different chronic diseases, but no study has been found on obese individuals with Type 2 diabetes. Therefore, reikinin in obese individuals with Type 2 diabetes; This study is planned to determine whether it has an effect on compliance with diabetes treatment, eating behaviors, anxiety levels and changes in metabolic values.
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Being tested
- REİKİ
- Keywords
- Reiki, Type 2 DM, Obesity, Eating Behavior, TREATMENT COMPLIANCE BEHAVIORS, NURSING CARE
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REİKİOther
Reiki is applied as an alternative and complementary treatment method.
| Study group | Role | What they receive |
|---|---|---|
| group receiving reiki | Individuals who will undergo Reiki for 12 weeks Receives: Other: REİKİ | |
| control group | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Reiki has a positive effect on adherence to treatment, eating behaviors and metabolic values in obese individuals with type 2 diabetes.
Metabolic changes in the patient before and after reiki
Measured: 12 weeks
Blood glucose level
HbA1c change in the patient before and after reiki
Measured: 12 weeks
Blood cholesterol level
Blood cholesterol exchange level
Measured: 12 weeks
Blood pressure
Blood pressure status
Measured: 12 weeks
Body mass index
Body mass index change
Measured: 12 weeks
Belly circumference measurement
waist circumference will be measured with a tape measure
Measured: 12 weeks
Anxiety level change
TO BE EVALUATED BY SCALE
Measured: 12 weeks
Change in eating behavior
The change in eating behavior will be evaluated with a scale
Measured: 12 weeks
Change in adherence to treatment
change in adherence to treatment will be evaluated with a scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start15 Sep 2022
- Primary completion15 Jul 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatmaz zehra KÜÇÜK, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942079
- Sponsor's protocol ID
- 2022/076
- Status last verified
- Jul 2023
- First submitted
- 26 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki on Treatment Compliance, Eating Behaviors and Metabolic Values in Obese Individuals With Type 2 Diabetes": Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05942079
- Acronym / sponsor ID
- 2022/076
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Keywords
- Reiki, Type 2 DM, Obesity, Eating Behavior, TREATMENT COMPLIANCE BEHAVIORS, NURSING CARE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 12 Jul 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.
The increase in the prevalence of diabetes and the loss of various organs and functions in the individual as a result of complications caused by diabetes affect the life expectancy and quality of individuals, and cause social and economic losses affecting the whole society. For this reason, the individual management of the diabetic patient is important in terms of ensuring effective participation and compliance in treatment and care. Patients must have knowledge, skills and positive attitudes in order to successfully comply with diabetes treatment. Patients are in compliance with diabetes treatment; they encounter some barriers such as medication barriers, barriers to self-monitoring, knowledge and belief barriers, barriers to diagnosis, barriers in relations with health professionals, barriers to lifestyle change, barriers to coping with diabetes, and barriers to getting advice and support. The American Diabetes Association (ADA) states that self-monitoring of blood sugar is important in ensuring glycemic control and preventing hyperglycemia and asymptomatic hypoglycemia. Reiki is applied as an alternative and complementary treatment method. Reiki application, when used together with pharmacological methods, chronic fatigue, diabetic neuropathy, pain caused by surgery, cancer treatment, symptoms of cardiovascular diseases, emotional disorders such as anxiety, depression, acute or chronic pain, infertility-related problems, neurodegenerative disorders, AIDS, autism and developmental disorders, Crohn's disease, irritable bowel syndrome, traumatic brain injury and has been shown to improve health problems such as fatigue.
In the literature, the effects of reiki have been examined in patient groups with different chronic diseases, but no study has been found on obese individuals with Type 2 diabetes. Therefore, reikinin in obese individuals with Type 2 diabetes; This study is planned to determine whether it has an effect on compliance with diabetes treatment, eating behaviors, anxiety levels and changes in metabolic values.
Detailed description
The increase in the prevalence of diabetes and the loss of various organs and functions in the individual as a result of complications caused by diabetes affect the life expectancy and quality of individuals, and cause social and economic losses affecting the whole society. Diabetes with poor management causes many acute and chronic complications. Keeping diabetes under control seriously affects the occurrence of microvascular and macrovascular complications, which develop over years and seriously affect life. Compliance with diabetes treatment; nutrition therapy, regular exercise program, patient self-monitoring, medication, access to health facilities and patient education. With regular monitoring and monitoring of these parameters, compliance with a successful diabetes treatment is improved. The basis of compliance with diabetes treatment is determined by the attitudes and behaviors of patients regarding their own health. For this reason, the individual management of the diabetic patient is important in terms of ensuring effective participation and compliance in treatment and care. Patients must have knowledge, skills and positive attitudes in order to successfully comply with diabetes treatment. Patients are in compliance with diabetes treatment; they encounter some barriers such as medication barriers, barriers to self-monitoring, knowledge and belief barriers, barriers to diagnosis, barriers in relations with health professionals, barriers to lifestyle change, barriers to coping with diabetes, and barriers to getting advice and support. The inability of the individual to cope with these obstacles adequately causes problems in compliance with diabetes treatment. One of the most important points in compliance with diabetes management and treatment is self-monitoring of blood glucose. The American Diabetes Association (ADA) states that self-monitoring of blood sugar is important in ensuring glycemic control and preventing hyperglycemia and asymptomatic hypoglycemia. HbA1c levels were found to be lower in patients who measured their blood glucose more frequently. In patients with poor diabetes management and persistent hyperglycemia, there is an increase in HbA1c value. A 1% increase in HbA1c value is accepted as a risk in the formation of complications. Reiki is applied as an alternative and complementary treatment method. Reiki application, when used together with pharmacological methods, chronic fatigue, diabetic neuropathy, pain caused by surgery, cancer treatment, symptoms of cardiovascular diseases, emotional disorders such as anxiety, depression, acute or chronic pain, infertility-related problems, neurodegenerative disorders, AIDS, autism and developmental disorders, Crohn's disease, irritable bowel syndrome, traumatic brain injury and has been shown to improve health problems such as fatigue (43).
In the literature, the effects of reiki have been examined in patient groups with different chronic diseases, but no study has been found on obese individuals with Type 2 diabetes. Therefore, reikinin in obese individuals with Type 2 diabetes; This study is planned to determine whether it has an effect on compliance with diabetes treatment, eating behaviors, anxiety levels and changes in metabolic values.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group receiving reiki | – | Other: REİKİIndividuals who will undergo Reiki for 12 weeks |
| control group | – | –control group |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Having been diagnosed with Type 2 diabetes at least 6 months ago, Body mass index ≥ 30 kg/m², Being on oral therapy or using insulin
Key inclusion criteria (5 listed)
- Having been diagnosed with Type 2 diabetes at least 6 months ago,
- Body mass index ≥ 30 kg/m²
- Being on oral therapy or using insulin,
- Ability to communicate and read,
- Volunteering to participate in research
Key exclusion criteria (3 listed)
- Not complying with the principle of voluntarism
- Answering data collection forms incompletely
- Desire to leave the study at any stage of the study
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 |
|---|---|---|
| REİKİReiki is applied as an alternative and complementary treatment method. | Other | group receiving reiki |
Primary outcome
"Reiki has a positive effect on adherence to treatment, eating behaviors and metabolic values in obese individuals with type 2 diabetes.
Time frame: 12 weeks
Metabolic changes in the patient before and after reiki
Blood glucose level
Time frame: 12 weeks
HbA1c change in the patient before and after reiki
Blood cholesterol level
Time frame: 12 weeks
Blood cholesterol exchange level
Blood pressure
Time frame: 12 weeks
Blood pressure status
Body mass index
Time frame: 12 weeks
Body mass index change
Belly circumference measurement
Time frame: 12 weeks
waist circumference will be measured with a tape measure
Anxiety level change
Time frame: 12 weeks
TO BE EVALUATED BY SCALE
Change in eating behavior
Time frame: 12 weeks
The change in eating behavior will be evaluated with a scale
Change in adherence to treatment
Time frame: 12 weeks
change in adherence to treatment will be evaluated with a scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 in Obese, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
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 5 inclusion and 3 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 Fatmaz Zehra FZ KÜÇÜK (05327443029, zehraklc2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Reiki has a positive effect on adherence to treatment, eating behaviors and metabolic values in obese individuals with type 2 diabetes. (time frame: 12 weeks). The study lists 9 primary outcomes in all. 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 12 Jul 2023.