Examining the Influence of Guided Meditation on Diabetes-related Distress and Glycemic Control

Study Overview
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Brief Summary
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The study aims to investigate the effects of Guided Meditation on diabetes-related distress and glycemic control in hospitalized Type 1 adolescent diabetic patients. The study will employ a randomized controlled trial design, with participants randomly assigned to either the intervention group (receiving Guided Meditation sessions) or the control group (receiving standard care). The primary outcomes measured will be diabetes-related distress levels and glycemic control (HbA1c levels).

Detailed Description
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The researchers hypothesize that the intervention group will experience a reduction in diabetes-related distress and an improvement in glycemic control compared to the control group. The study's findings could suggest how guided meditation could help manage the emotional distress and enhance diabetes management in hospitalized Type 1 adolescent diabetic patients.

Official Title
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Examining the Influence of Guided Meditation on Diabetes-related Distress and Glycemic Control: A Randomized Controlled Trial Among Hospitalized Type 1 Adolescent Diabetic Patients

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Guided meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescent patients aged between 12 to 18 years. Confirmed diagnosis of Type 1 diabetes mellitus. Hospitalized in the participating medical facility. Capable of providing informed consent (for participants aged 18) or providing assent with parental/legal guardian consent (for participants aged 12 to 17). Exclusion Criteria: Presence of severe psychiatric disorders or cognitive impairments that may hinder participation in the guided meditation sessions. Physical limitations or medical conditions that prevent the safe participation in the intervention or assessment procedures. Previously engaged in regular meditation or mindfulness practices, which may confound the results. Inability to communicate effectively in the language used for assessments and interventions.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group MTG<br>The intervention arm received Guided Meditation sessions | Behavioral: Guided meditation<br>* Meditation with guidance<br>|
| No Intervention: Group STG<br>The control arm received standard care without any Guided meditation sessions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes distress scale | Diabetes distress scale questionnaire | Week 1 and Week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels | HbA1c levels | Week 1 and Week 13 | 
| Number of hypoglycemic and hyperglycemic episodes | Number of hypoglycemic and hyperglycemic episodes | Week 1, 4, 8 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Type 1 diabetes mellitus, Guided meditation