Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 diabetes mellitus, Guided meditation, Adolescents
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).
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.
Interventions
BEHAVIORALGuided meditation
Meditation with guidance
Sponsors
Shifa International Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor did not know which patients received the intervention and which patients did not
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes distress scale | Week 1 and Week 13 | Diabetes distress scale questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Pakistan
Outcome results
None listed