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

Sponsor

Shifa International Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06151821

Collaborator

(none)

Enrollment

Location

Arms

2.1

Actual Duration (Months)

32.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Behavioral: Guided meditation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes assessor did not know which patients received the intervention and which patients did not

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Aug 1, 2023

Actual Primary Completion Date :

Oct 2, 2023

Actual Study Completion Date :

Oct 3, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Diabetes distress scale [Week 1 and Week 13]
Diabetes distress scale questionnaire

Secondary Outcome Measures

HbA1c levels [Week 1 and Week 13]
HbA1c levels
Number of hypoglycemic and hyperglycemic episodes [Week 1, 4, 8 and 12]
Number of hypoglycemic and hyperglycemic episodes

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shifa Hospital	Lahore		Pakistan

Sponsors and Collaborators

Shifa International Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Saima Abass Tahammal, Principal Investigator, Shifa International Hospital

ClinicalTrials.gov Identifier:

NCT06151821

Other Study ID Numbers:

SH-34988383

First Posted:

Nov 30, 2023

Last Update Posted:

Nov 30, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Saima Abass Tahammal, Principal Investigator, Shifa International Hospital

Type 1 diabetes mellitus

Guided meditation

Adolescents

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 30, 2023