- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382492
Clinical Effect of Swedish Massage Versus Adjuvant Yoga on Blood Glucose Level in Children With Type 1 Diabetes Mellitus
Study Overview
Status
Conditions
Detailed Description
Swedish massage (SM) and yoga are complementary non-pharmacological techniques that have recently been used in managing chronic disorders such as type 1 diabetes mellitus (T1DM). Both techniques play an important role in reducing stress, which contributes to lowering blood glucose levels in children with T1DM. Objective: To investigate the effect of Swedish massage versus children's yoga exercises on blood glucose levels of children with T1DM
Progressive muscle relaxation (PMR) is one of the best effective non-pharmacological techniques, which decreases stress in children because it influences mental and physical conditions. It can be applied by making the muscles maximally strain, and then loosening it until the muscle is relaxed. It is repeated until children acquire complete relaxation (Casman & Nurhaeni, 2018).
Progressive muscle relaxation leads to regulation of autonomic nervous system activity that potentially contributes to medical management of T1DM through improving in glycosylated hemoglobin level (HbA1c) (Paschali et al., 2020). Swedish massage and Progressive muscle relaxation had an effective role in decreasing blood glucose level in children with T1DM, so that the pediatric nurse should apply and educate care giver about Swedish massage and PMR techniques (Ismaili et al., 2018)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Cairo Governorate
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Cairo, Cairo Governorate, Egypt, 11571
- Outpatient Clinics of Universities and Private Medical Centers in Cairo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diabetic children's age: 6 - 12 years.
- Children who live in Cairo only.
- Free from other medical disorders as cardiac, renal, or any other metabolic disorder
Exclusion Criteria:
- Diabetic children who can't understand the order
- Diabetic patient's who have medical disorders as cardiac,renal and other metabolic disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diabetic children who received Swedish massage
Twenty-five diabetic children who received Swedish massage in addition to routine nursing care of the unit for diabetes.
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Swedish massage in addition to routine nursing care of the unit for diabetes.
|
|
Experimental: Diabetic children who received children's yoga exercises
Twenty-five diabetic children who received children's yoga exercises in addition to routine nursing care of the unit for diabetes.
|
yoga exercises in addition to routine nursing care of the unit for diabetes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting blood glucose
Time Frame: 6 weeks
|
measures sugar in your blood after an 8-12 hour fast (only water allowed), primarily to check for diabetes or prediabetes by showing your baseline sugar levels, with normal being under 100 mg/dL, prediabetes 100-125 mg/dL, and diabetes 126 mg/dL or higher on two separate tests,
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Random Blood sugar
Time Frame: 6 weeks
|
measures blood sugar levels at any time, without fasting, to screen for diabetes, with normal for healthy adults generally under 140 mg/dL (7.8 mmol/L).
Levels between 140-199 mg/dL suggest prediabetes, while 200 mg/dL or higher often indicates diabetes,
|
6 weeks
|
|
Glycosylated Hemoglobin (HbA1c).
Time Frame: 6 weeks
|
a blood test measuring average blood sugar levels over the past 2-3 months by showing the percentage of sugar-coated hemoglobin in red blood cells,
|
6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Swedish massage yoga type 1 DM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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