To assess effect of Bhaktivedanta mantra and music audio therapy on blood sugar levels and stress levels in patients diagnosed with gestational diabetes and pregnant women having diabetes risk factors.

A two arm, prospective, single centre, interventional, randomized, controlled study to assess effect of Bhaktivedanta mantra and music audio therapy on outcome of blood sugar levels and stress levels, in patients diagnosed with gestational diabetes and pregnant women’s having diabetes risk factors in a tertiary care institute. - NIL

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056720

Enrollment

102

Registered

2023-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O249- Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium

Interventions

Intervention1: Spiritual Care Intervention: The study intervention includes mantras which are pre-recorded in a radio device, which comprises of mantras like Aditya Hriday kavacha,Dhanvantari mantra,

Eligibility

Inclusion criteria

Inclusion criteria: 1. Females, Age = 18 years. 2. Patients diagnosed with GDM during prenatal visit with glucose level of Fasting = 92. 3. Patients whose post prandial blood sugar level ranges from 1 hour = 140, 2 hours = 120 based on Oral glucose tolerance tests (OGTT). 4. Pregnant women visiting prenatal clinic having diabetes risk factors which includes the following: Overweight, Family history of type 2 DM., Prediabetic, Previously given birth to an infant weighing greater than 9 pounds,History of GDM in previous pregnancy.

Exclusion criteria

Exclusion criteria: 1. Patients on steroids. 2. Patients diagnosed with AK strain transforming (AKT). 3. Patients diagnosed with chronic kidney disease (CKD). 4. Patients diagnosed with Chronic Lung Disease (CLD). 5. Patients with pre gestational diabetes.

Design outcomes

Primary

Measure	Time frame
1. To evaluate the effect of Bhaktivedanta mantra & music audio therapy in changes of blood sugar levels in GDM patients. 2. To evaluate the effect of Bhaktivedanta mantra & music audio therapy in changes of blood sugar level in patients with high risk factors for developing GDM.Timepoint: 1. The coping up of GDM capability of patients assigned in both the groups will be evaluated by using a tool named “Glucocopper ? once in a month. 2. The changes in stress level of the patients assigned in both the groups will be evaluated by using Diabetic Distress Scale at timepoints mentioned below: a) 28th week-(±7 days) b) 32nd week- (±7 days) c) 36th week- (±7 days) d) At the timepoint of delivery (±7 days) e) Post partum -6th week -(±7 days)	—

Measure

Time frame

1. To evaluate the effect of Bhaktivedanta mantra & music audio therapy in changes of blood sugar levels in GDM patients. 2. To evaluate the effect of Bhaktivedanta mantra & music audio therapy in changes of blood sugar level in patients with high risk factors for developing GDM.Timepoint: 1. The coping up of GDM capability of patients assigned in both the groups will be evaluated by using a tool named “Glucocopper ? once in a month. 2. The changes in stress level of the patients assigned in both the groups will be evaluated by using Diabetic Distress Scale at timepoints mentioned below: a) 28th week-(±7 days) b) 32nd week- (±7 days) c) 36th week- (±7 days) d) At the timepoint of delivery (±7 days) e) Post partum -6th week -(±7 days)

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Secondary

Measure	Time frame
1. To evaluate if any of these patients develop PIH. 2. To evaluate the changes in blood pressure of the patients. 3. To evaluate the changes in stress level of the patients. 4. To evaluate the duration in which the sugar level comes to a normal range postpartum period. 5. To evaluate the up titration of medicines for diabetes.Timepoint: 1. The coping up of GDM capability of patients assigned in both the groups will be evaluated by using a tool named “Glucocopper ? once in a month. 2. The changes in stress level of the patients assigned in both the groups will be evaluated by using Diabetic Distress Scale at timepoints mentioned below: a) 28th week-(±7 days) b) 32nd week- (±7 days) c) 36th week- (±7 days) d) At the timepoint of delivery (±7 days) e) Post partum -6th week -(±7 days)	—

Measure

Time frame

1. To evaluate if any of these patients develop PIH. 2. To evaluate the changes in blood pressure of the patients. 3. To evaluate the changes in stress level of the patients. 4. To evaluate the duration in which the sugar level comes to a normal range postpartum period. 5. To evaluate the up titration of medicines for diabetes.Timepoint: 1. The coping up of GDM capability of patients assigned in both the groups will be evaluated by using a tool named “Glucocopper ? once in a month. 2. The changes in stress level of the patients assigned in both the groups will be evaluated by using Diabetic Distress Scale at timepoints mentioned below: a) 28th week-(±7 days) b) 32nd week- (±7 days) c) 36th week- (±7 days) d) At the timepoint of delivery (±7 days) e) Post partum -6th week -(±7 days)

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Countries

India

Contacts

Public ContactDr Komal Dalal

Bhaktivedanta Hospital and Research Institute

drkomal@bhaktivedantahospital.com9324611435

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026