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

NCT ID: NCT06151821

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-10-03

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus

Keywords

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Type 1 diabetes mellitus Guided meditation Adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

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

Study Groups

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Group MTG

The intervention arm received Guided Meditation sessions

Group Type EXPERIMENTAL

Guided meditation

Intervention Type BEHAVIORAL

Meditation with guidance

Group STG

The control arm received standard care without any Guided meditation sessions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Guided meditation

Meditation with guidance

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shifa International Hospital

OTHER

Sponsor Role lead

Responsible Party

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Saima Abass Tahammal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saima Abbass, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Shifa hospital

Locations

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Shifa Hospital

Lahore, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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SH-34988383

Identifier Type: -

Identifier Source: org_study_id