An Observational study of music therapy on anxiety level in female patients undergoing surgery under spinal anaesthesia
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
ï¶ 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
ï¶ 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
Dr Vaibhavi Hajariwala
PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY
