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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Guided meditation

• Registration Number: NCT06151821
• Lead Sponsor: Shifa International Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-08-02
• Primary Completion: 2023-10-02
• Study Completion: 2023-10-03
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-21
• Last Update Submitted: 2023-11-21
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group MTG	Guided meditation	The intervention arm received Guided Meditation sessions

Primary Outcome Measures

Name	Time	Method
Diabetes distress scale	Week 1 and Week 13	Diabetes distress scale questionnaire

Secondary Outcome Measures

Name	Time	Method
HbA1c levels	Week 1 and Week 13	HbA1c levels
Number of hypoglycemic and hyperglycemic episodes	Week 1, 4, 8 and 12	Number of hypoglycemic and hyperglycemic episodes

Trial Locations

Locations (1)

Shifa Hospital; 🇵🇰 Lahore, Pakistan