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

NCT06151821 | Completed

• 1 other identifier: SH-34988383
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitus; Guided meditation; Adolescents

Outcome Measures

Primary Outcomes (1)

• Diabetes distress scale

  Diabetes distress scale questionnaire

  Week 1 and Week 13

Secondary Outcomes (2)

• HbA1c levels

  Week 1 and Week 13

• Number of hypoglycemic and hyperglycemic episodes

  Week 1, 4, 8 and 12

Study Arms (2)

Group MTG

EXPERIMENTAL

The intervention arm received Guided Meditation sessions

Behavioral: Guided meditation

Group STG

NO INTERVENTION

The control arm received standard care without any Guided meditation sessions

Interventions

Guided meditation BEHAVIORAL

Meditation with guidance

Group MTG

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shifa International Hospital: lead

Study Sites (1)

Shifa Hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Saima Abbass, MD, MSc

  Shifa hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor did not know which patients received the intervention and which patients did not
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: November 30, 2023
• Study Start: August 1, 2023
• Primary Completion: October 2, 2023
• Study Completion: October 3, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)