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Clinical Trials/NCT06151821
NCT06151821
Completed
Not Applicable

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

Shifa International Hospital1 site in 1 country68 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Shifa International Hospital
Enrollment
68
Locations
1
Primary Endpoint
Diabetes distress scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
October 3, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shifa International Hospital
Responsible Party
Principal Investigator
Principal Investigator

Saima Abass Tahammal

Principal Investigator

Shifa International Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Diabetes distress scale

Time Frame: Week 1 and Week 13

Diabetes distress scale questionnaire

Secondary Outcomes

  • HbA1c levels(Week 1 and Week 13)
  • Number of hypoglycemic and hyperglycemic episodes(Week 1, 4, 8 and 12)

Study Sites (1)

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