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临床试验/CTRI/2024/03/064560
CTRI/2024/03/064560尚未招募4 期

Randomized comparative study of Virtual reality vs music therapy with Midazolam in decreasing anxiety in patients undergoing upper limb nerve blocks

Teerthanker Mahaveer Medical College and Research Centre1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年5月22日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare State Trait Anxiety Inventory-6 (STAI-6) between two groups

研究概览

简要总结

This study is planned in context that Non pharmacological interventions are becoming popular as compared to pharmacological treatments in reducing preoperative anxiety due to their less adverse effects to decrease anxiety and pain experienced by the patients.

After getting approval from Institutional Ethical Committee ( IEC) , those patients who are fit in inclusion criteria will be included in our study.

Anxiety scores will be calculated by the Speilberger’s validated tool, the State trait anxiety invetory score (STAI-6)  range from 6 to 24.

Randomization using computer generated random number which are sealed in opaque envelop will be done.

GROUP 1- MUSIC THERAPY GROUP 2- VIRTUAL REALITY

USG guided Regional anesthesia will be delivered as per the institution protocol.

Before and after adminstration of upper limb nerve block , Anxiety scores based on STAI-6 tool will be calculated.

The patient and provider satisfaction scores will be recorded using a 10-point visual analogue scale

Evaluation of communication difficulties between provider and patient will be done by the response based on a 5-point Likert scale

Hemodynamics parameters (HR, RR, SBP, DBP, MAP, SpO2) will be monitored pre operatively,during the procedure every 5 mins and after procedure.

Data will be analyzed using the appropriate statistical method.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient Posted for Upper limb surgeries
  • Written and informed consent
  • Age 18-60 years 4.

排除标准

  • Patients with any underlying coagulopathy Patients with significant psychiatric disorders K/C/O hypersensitivity to local anesthesia Patients who are extremely anxious (scores ≥50 on the STAI-6 tool) Possible complications (Headache, Nausea, Vomiting and Claustrophobia).

结局指标

主要结局

To compare State Trait Anxiety Inventory-6 (STAI-6) between two groups

时间窗: Before (0mins) and after adminstration (30mins post procedure) of upper limb nerve block , Anxiety scores based on STAI-6 tool will be calculated.

次要结局

  • 1. To compare patient & physician satisfaction scores between two groups

研究者

发起方
Teerthanker Mahaveer Medical College and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shashank Jain

Teerthanker Mahaveer Medical College and Research Centre

研究点 (1)

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