Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 28, 2023
Date Accepted: Jul 15, 2024
Study to Evaluate the Comparative Efficacy of Medhya Rasayana (Pharmacological) Versus Non-Pharmacological Interventions in Management of Gadget Addiction in Children: Protocol for a Randomized Parallel Triple Arm Clinical Trial
ABSTRACT
Background:
Gadget addiction is a common behavioral problem among children. It is known to hamper social and academic life as well as adversely affect the lives of children. Ayurveda offers many therapeutic modalities and Ayurvedic medicines that can be used in the management of gadget addiction in children. The purpose of this study is to evaluate and compare the effectiveness of non-pharmacological therapies and the pharmaceutical intervention Medhya Rasayana in treating childhood gadget addiction.
Objective:
This article intends to provide a detailed description of the study methodology that will be used to compare the efficacy of non-pharmacological versus pharmaceutical interventions in the treatment of children's gadget addiction.
Methods:
A randomized, parallel, triple-arm interventional study will be conducted on diagnosed participants of gadget addiction with an age group of 6–16 year old children, which will be selected and equally distributed in two groups. Group P will be given Medhya Rasayana (pharmacological intervention), Group N will be non-pharmacological Ayurveda intervention, and Group C (cognitive behavioral therapy) will be an external group. The Study duration is 180 days with assessment at baseline, midpoint and at endpoint Appropriate statistical techniques, such as ANOVA and regression analysis, will be employed to examine the data and evaluate the efficacy of the three groups' interventions. We will perform subgroup analysis according to initial addiction severity, gender, and age.Primary outcome measures include reduction in gadget addiction and changes in psychosocial well being of participants. standardized Questionnaires and instruments will be used to collect data.
Results:
In December 2023, the randomized controlled study got underway. Since participants may begin at any time, our goal is for everyone to be finished by December 2024.
Conclusions:
This research will provide crucial new information about the relative effectiveness of Ayurveda non-pharmacological therapies and Medhya Rasayana in treating children's gadget addiction. The results will guide evidence-based treatments aimed at reducing the negative impact of excessive gadget use on this susceptible population's psychosocial development. In the end, the findings are meant to help policymakers and medical professionals create sensible plans to deal with the rising issue of childhood gadget addiction. Clinical Trial: Clinical Trial Registry of India, registration number: CTRI/2021/10/037211
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