跳至主要内容
临床试验/CTRI/2024/09/074478
CTRI/2024/09/074478尚未招募不适用

Effect of Binaural Beat Music on Perioperative Anxiety and Stress among patients undergoing Femur bone Fracture Surgery under Spinal Anesthesia: A prospective randomized study

AIIMS BHOPAL1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年10月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS BHOPAL
入组人数
70
试验地点
1
主要终点
Comparison between STAI-6(State trait anxiety inventory) in both groups.

研究概览

简要总结

Patients subjected to surgeries are exposed to intense anxiety and stress. Spinal anaesthesia further increases anxiety because patient is either awake or slightly sedated and exposed to multiple anxiety provoking visual and auditory stimuli. Perioperative anxiety and psychological stress lead to activation of HPA  and sympathetic nervous system resulting in neurohormonal responses reflected in cortisol levels and causes hemodynamic instability. It calls for increased pharmacological interventions which might hinder recovery following anaesthesia and induce undesirable dose dependent cardiorespiratory and CNS depression.

Extensive researches on efficacy of binaural beat music in anxiety, pain perception and relaxation has shed light to use it as an intervention to alleviate anxiety and physiological responses to surgery. Various studies have indicated the prevalence of anxiety highest with orthopedics procedures which uses hammers, drills and other louder instruments .Anxiety comparatively higher among patients who had femur bone procedures because of sudden constraints on movement couples with excruciating pain and quick medical process that decided the diagnosis and treatment course.

Thus we decided to conduct a randomized control study on effects of binaural beat music on perioperative anxiety and stress in patients undergoing femur bone fracture surgery under spinal anesthesia. As salivary biomarkers have proven to be better than blood markers in stress related research ,the influence of binaural music on stress analyzed by salivary cortisol  and perioperative anxiety in both groups compared using more objective scale such as State Trait Anxiety Inventory scoring scales.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA (American Society of Anaesthesiologists classification of physical status) grade 1,2 and 3 patients aged more than 18 years with upper limit of age 70 years of either sex with consent and those who understand Bluetooth / headphone noise cancellation gadgets comfortably undergoing femur bone fracture surgery under spinal anaesthesia in our institute.

排除标准

  • Patients refusing informed consent Contradications to spinal anaesthesia Any treatment that affects physiological status or presence of psychiatric disorder Patients with hearing impairment.

结局指标

主要结局

Comparison between STAI-6(State trait anxiety inventory) in both groups.

时间窗: Baseline | By the end of surgery

Salivary cortisol levels in response to neurohormonal response to surgery in both groups

时间窗: Baseline | By the end of surgery

次要结局

  • Total sedation requirements in each group.(Difference in hemodynamic variables (Heart Rate, Mean Arterial Pressure, Diastolic and Systolic blood pressure) in both groups.)

研究者

发起方
AIIMS BHOPAL
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Riya Rose Jojo

All India Institute Of Medical Sciences, Bhopal

研究点 (1)

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