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NCT06151821 Clinical Trial

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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06151821
Other study ID # SH-34988383
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date October 3, 2023

Study information
Verified date November 2023
Source Shifa International Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date October 3, 2023
Est. primary completion date October 2, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Guided meditation
Meditation with guidance

Locations
Country Name City State
Pakistan Shifa Hospital Lahore

Sponsors (1)
Lead Sponsor Collaborator
Shifa International Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diabetes distress scale Diabetes distress scale questionnaire Week 1 and Week 13
Secondary HbA1c levels HbA1c levels Week 1 and Week 13
Secondary Number of hypoglycemic and hyperglycemic episodes Number of hypoglycemic and hyperglycemic episodes Week 1, 4, 8 and 12
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