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

November 21, 2023 updated by: Saima Abass Tahammal, Shifa International Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan
        • Shifa hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shifa International Hospital

Investigators

  • Principal Investigator: Saima Abbass, MD, MSc, Shifa hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

October 3, 2023

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-34988383

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe