跳至主要内容
临床试验/CTRI/2024/12/077679
CTRI/2024/12/077679尚未招募4 期

An Observational study of music therapy on anxiety level in female patients undergoing surgery under spinal anaesthesia

SHREE KRISHNA HOSPITAL1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年12月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
88
试验地点
1
主要终点
Assess the effect of music on peri-operative anxiety in female patients

研究概览

简要总结

Material and method:

2.1 Source of data

After obtaining the ethics committee’s approval, samples collected for a duration of 1 year, from April

2024 to April 2025, atleast 88 patients undergoing elective surgeries requiring spinal anaesthesia in

Shree Krishna hospital, Karamsad, Anand will be included in the study.

2.2 Methodology

 Inclusion criteria

• Females

• Age more than 20 years and less than 60 years

• American Society of Anesthesiologists – ASA grade 1-3

• Patients undergoing elective surgeries under spinal anesthesia

 Exclusion criteria

• Patients undergoing

• Patients with contra-indication to spinal anaesthesia

• Patients undergoing emergency surgeries

• Patients with psychological disorders

• Patients with hearing deficits

• Patients with cognitive dysfunction

Patients posted for surgeries under spinal anaesthesia will be included in this study.

Upon informed consent, patients will be assessed in the recovery room before shifting to the

operation theatre. In the recovery room pre operative vitals of the patient – temperature, pulse,

blood pressure, oxygen saturation, respiratory rate will be marked.

Patients will be asked to rate their anxiety using Visual Analogue Scale for Anxiety (VAS-A)

scale. This was considered as baseline-VAS-A.

For this study, we will provide our own headphones to all patients. The choice of music will

be based on patient’s own choice of music that she prefers. This will be started atleast 10

minutes before shifting to the operating table.

On the operative table, patient will be given sitting position, under all aseptic precaution local

anaesthesia will be given. After giving spinal anaesthesia, patient will be made to give supine

position. After assessment and confirmation of desired spinal anaesthesia effect, patient will be

again started on music via the given headphones till completion of surgery.

During Operation, patients will be assessed if there was any need for intra-operative sedation

requirement.

During operation patient’s VAS-A score will be monitored. If VAS-A score exceeds 4 AND

if the pulse rate exceeds more than 100/min, intra-operative sedation will be started.

The level of Sedation will be decided based on Ramsay Sedation score (21)

After completion of the surgery, patient will be shifted to post-operative care unit. Here, patient

will be asked to rate their anxiety again using VAS-A scale. This will be considered Post-Op

VAS-A.

Patient will be asked her satisfaction level based on Likert scale.

Surgeons will be asked their satisfaction of conducting surgery and will be asked to scale it

according to Likers scale

Baseline and Post-OP VAS-A scale will be compared and assessed if music relieves the anxiety

levels in these patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

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

入选标准

  • American Society of Anesthesiologists – ASA grade 1-3 Patients undergoing elective surgeries under spinal anesthesia.

排除标准

  • Patients with contra-indication to sinal anaesthesia Patients undergoing emergency surgeries Patients with psychological disorders Patients with hearing deficits Patients with cognitive dysfunction.

结局指标

主要结局

Assess the effect of music on peri-operative anxiety in female patients

时间窗: 15 minutes before and 15 minutes after procedure

次要结局

  • Assess the requirement of sedation in these patients(Every 5 minutes during surgery)
  • Compare pre-operative & post-operative vitals(Atleast 15 minutes Before & 15 minutes after operation)
  • Assess patient’s satisfaction score(Assess surgeon’s satisfaction score)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vaibhavi Hajariwala

PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY

研究点 (1)

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