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NCT Number: NCT06151821

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

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).

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shifa Hospital

Lahore, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Meditation

Behavioral

Meditation with guidance

Primary outcomes

  1. Diabetes distress scale

    Time frame: Week 1 and Week 13

    Diabetes distress scale questionnaire

Secondary outcomes

  1. HbA1c levels

    Time frame: Week 1 and Week 13

    HbA1c levels

  2. Number of hypoglycemic and hyperglycemic episodes

    Time frame: Week 1, 4, 8 and 12

    Number of hypoglycemic and hyperglycemic episodes

Sponsors and collaborators

Lead sponsor

Shifa International Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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