Intraoperative music therapy in patients undergoing total knee replacement under general anaesthesia -- A randomized controlled trial.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The immediate emergent post-operative pain scoring is expected to be significantly lower in the test population (Experimental-group) in comparison to the control subjects (Control-group).
研究概览
简要总结
Music can beused as a non-pharmacological adjuvantwith lesser adverse effects in anaesthetic and pain management in theintra-operative and immediate post-operative period.
Pain asdefined by International Association forthe Study of Pain is the unpleasant sensory and emotional experience associatedwith actual or potential tissue damage.
Recent studiesemphasise the bi-dimensional nature of pain, comprising of asensory-discriminative dimension and an affective-motivational dimension.
A systematicreview conducted by K. Talbot et al, suggests that the Anterior cingulatecortex(ACC), spino-parabrachio-amygdaloid and spinoparabrachio-hypothalamicareas are to be involved in the affective dimension of the pain.
A trial with theuse of remifentanil and the positive suggestions intervention to evaluate painexperienced by patients reveals that by modulating the affective dimension ofthe pain, the degree of unpleasantness and the pain tolerability can becontrolled or manipulated.
A study byIkonomidou et al. shows that postoperative opioid consumption and perioperativehemodynamic stability are satisfactory in the interventional groupsadministered music.
A study done by Jayaraman et al in patientsundergoing laparoscopic cholecystectomy revealed a significantly lowered VASscore in the interventional group with music.
A systematic review and a meta-analysis byHole J, Hirsch M, Ball E, et al suggest that music acts on the modulation ofpain by multifactorial mechanisms, one such is the stimulation of endogenousopioids and by influencing the afferent conduction of the noxious stimulus.
From the abovefacts, the hypothesis that music influences the affective dimension of pain isto be studied in patients undergoing total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient undergoing total knee replacement surgery.
- •ASA I and ASA II patients(people without any comorbidities or systemic diseases that are under control).
排除标准
- •Patients with hearing impairment.
- •Patients who are non-compliant with the music.
- •Patients with psychiatric disorders.
结局指标
主要结局
The immediate emergent post-operative pain scoring is expected to be significantly lower in the test population (Experimental-group) in comparison to the control subjects (Control-group).
时间窗: Immediate post-extubation pain scores recorded using a numerical intensity scale will be taken for analysis.
次要结局
- The intra-operative requirements of the anaesthetic & analgesic agents are expected to be significantly reduced on adjuvant administration of music therapy during the intra-operative period(The vitals[BLOOD PRESSURE, Heart rate, Saturation], Entropy are noted just prior to administration of anaesthesia & thereater at 5, 10,15,30,60,120minutes & just after extubation.The total dose of the various drugs administered to the patient from the point of induction of anaesthesia till the point when the patient is extubated is to be recorded. These details will be used for analysis.)