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临床试验/CTRI/2025/12/098625
CTRI/2025/12/098625尚未招募不适用

A comparative evaluation of efficacy of smartphone based intervention v/s standard premedication using oral midazolam for preoperative anxiety in paediatric patients.

Pt. B.D Sharma, PGIMS, Rohtak1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This thesis aims to evaluate and compare the effectiveness of smartphone-based interventions versus oral midazolam in managing preoperative anxiety among pediatric patients undergoing elective surgery under general anesthesia. Preoperative anxiety affects up to 60% of children and is associated with difficult anesthetic induction, prolonged recovery, and negative postoperative behaviors. While oral midazolam remains a standard pharmacological premedication, it carries risks such as paradoxical reactions, respiratory depression, and delayed recovery. Non-pharmacological strategies, particularly digital tools like smartphone-based distraction and relaxation applications, have shown promising results internationally but remain underexplored in India.

The proposed study will be a prospective, randomized controlled trial conducted at Pt. B.D. Sharma PGIMS, Rohtak, involving 60 children aged 3–7 years (ASA I and II), divided equally into two groups: smartphone intervention and oral midazolam. Outcomes will be assessed using validated scales—the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF) for child anxiety, the Induction Compliance Checklist (ICC) for cooperation during induction, perioperative hemodynamic monitoring, and the State-Trait Anxiety Inventory (STAI) for parental anxiety.

The findings are expected to determine whether smartphone-based methods can provide a safe, effective, and economical alternative to sedative premedication, potentially transforming pediatric perioperative care in resource-limited settings.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
2.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Children between age 2-6 years which fall under American society of Anaesthesiology(ASA) physical status 1 and 2 posted for elective surgery under general anaesthesia.

排除标准

  • Patient/guardian who refuses to give consent, child with history of any psychiatric illness, child with ongoing psychiatric medications, child with known intellectual disability, child with known severe visual and hearing impairment, child with previous anaesthetic exposure, child requiring emergency surgery.

研究者

发起方
Pt. B.D Sharma, PGIMS, Rohtak
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Vasudha Govil

Pt. B.D Sharma PGIMS Rohtak

研究点 (1)

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