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临床试验/CTRI/2023/10/059099
CTRI/2023/10/059099已完成不适用

To evaluate the effect of video education on preoperative anxiety in female patients ungergoing surgery under spinal anaesthesia.

Pt BD Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年10月31日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
To asses the effect of viewing video information on preoperative anxiety using APAIS score in female patients undergoing surgery under spinal anaesthesia.

研究概览

简要总结

Title : To evaluate the effect of viewing video information in reducing preoperative anxiety in female patients undergoing surgery under spinal anaesthesia.

Aim : To evaluate the effect of viewing video information in reducing preoperative anxiety in female patient undergoing surgery under spinal anaesthesia.

Primary Objective :

  1. To asses the effect of viewing video information on preoperative anxiety using APAIS score in female patients undergoing surgery under spinal anaesthesia.

Secondary Objective :

1 To observe the effect of anxiety on hemodynamic parameters.

2 To identify associated causes for the development of anxiety.

Inclusion criteria : All female patients of age 18 years to 60yrs, belonging to American Society of Anesthesiologists (ASA) physical status I - II scheduled to undergoing elective surgery under spinal anaesthesia.

Exclusion criteria : Patient refusal, contraindications to spinal anaesthesia, mental disorders, patients on antidepressants, beta blockers, previously received spinal anaesthesia, hearing and visual impairment.

Sample Size : 110

Group allocation : Video group (n = 55) = video viewed Control group (n=55) =verbal information given

Assessment :

Effect on APAIS anxiety score.

Effect of anxiety on hemodynamic parameters

Causes for developing anxiety

Analysis:

Data will be compiled, compared and appropriate statistical test will be applied to analyse the results

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • All female patients of age 18 years to 60yrs, belonging to American Society of Anaesthesiologists (ASA) physical status I or II scheduled to undergoing elective surgery under spinal anaesthesia.

排除标准

  • Contraindications to spinal anaesthesia, Mental disorders and patients on treatment for any psychiatric illness, Patients with major cardiac, renal and hepatic impairment, Previously received spinal anaesthesia, Pregnancy, Hearing and visual impairment, Patients with poor GCS, Patient refusal.

结局指标

主要结局

To asses the effect of viewing video information on preoperative anxiety using APAIS score in female patients undergoing surgery under spinal anaesthesia.

时间窗: A(0) - Base line evening before surgery. | A(1) - Post intervention. | A(2) - 30 mins before surgery.

次要结局

  • To observe the effect of anxiety on hemodynamic parameters.(Heart Rate (HR),Systolic Blood Pressure (SBP),Diastolic Blood Pressure (DBP))

研究者

发起方
Pt BD Sharma PGIMS Rohtak
申办方类型
Government medical college

研究点 (1)

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