Effects of Music on Pain and Anxiety During Post-operative Period in Closed Shaft Femur Fracture Patients in Serdang Hospital and University Malaya Medical Centre
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Pain score using the Numeric Rating Scale (NRS)
研究概览
简要总结
It has been hypothesized that because music has the ability to motivate, promote relaxation, alleviate pain and anxiety levels, to distract, and facilitate positive emotional states; thus it will enable healing by reducing anxiety levels which are associated with expected pain, hence patients are more unperturbed. In addition, several studies in the past have also identified that music listening can reduce the need for analgesics before surgery and after surgery to alleviate pain, reduce the period of post-operative pain and aid in the recovery period. While most studies which had administered music listening in the post-anaesthesia care unit (PACU), had found significant findings compared to patients that did not listen to music; there are few others which found otherwise.
Over decades, time and again, researchers have tried to understand how non-pharmacological interventions have been utilized in a spectrum of rehabilitation settings in populations to stimulate convalesces. This is because non-pharmacological interventions have been recognised as valuable, simple, safe, and inexpensive adjuvants to pharmacological approaches in pain management and therefore is valuable during post-operative rehabilitation especially.
This research is necessary because it hopes to address the gap of knowledge concerning the effects of music in post-operative pain, anxiety objectively in a specific population, and during an explicit time frame in a public hospital setting in Malaysia and whether by listening to music, the patients will require lesser amount of opioids analgesics.
The purpose of this study is to examine the effects of music on pain and anxiety during post-operative period in patients with closed shaft femur fracture at University of Malaya Medical Centre.
详细描述
The administration of music as an adjuvant to medicine during the recovery after surgery especially should be further explored by examining the physiological parameters of what takes place in the human body when pain and anxiety are present.
Permision to conduct this study have been granted by the National Medical Research Registry of the Ministry of Health of Malaysia, the Medical Research Ethics Committee from Universiti Putra Malaysia as well as University of Malaya.
During the intervention, the standard course of treatment by the attending physician will not be interrupted. The patients have the liberty to drop out from the study at any point of time without any repercussion.
The Standard Operating Procedure for all information obtained in this study will be kept and handled in a confidential manner, and destroyed thereafter analysis in accordance with applicable laws and regulations by the Ethics Committee of Universiti Putra Malaysia. When publishing or presenting the study results, the identity of the patients will not be revealed. Only individuals involved in this study such as the researchers, attending physicians, qualified monitors and auditors, Universiti Putra Malaysia or its affiliates and governmental or regulatory authorities can access the data from this study.
The sample size assessment to specify the number of participants was necessary to demonstrate an effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
To ensure non-bias during the randomization, both the researcher and the patient will be masked and this procedure will be carried out by a trained research assistant.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent to having the surgery and general anaesthesia
- •Free from cognitive impairment
- •Free from non-communicable diseases
- •Mentally stable
- •No appreciable deficits in vision and hearing
- •American Society of Anaesthesiology (ASA) physical status classification of 1, 2, or 3
- •Able to communicate either in English or Bahasa Malaysia
- •Admitted to the Orthopaedic ward post-operatively
- •Alert and cognizant to complete the pain and anxiety scores
排除标准
- •Patient refusal for surgery and anaesthesia
- •Patients anticipated to have difficult airway and planned for higher level airway management such as awake fibreoptic intubation, tracheostomy under local anaesthetic.
- •Patients who are cognitively impaired
- •Women under hormonal treatment
- •Diagnosed with auto immune disease
- •Deaf and vision impaired
- •Current use of anti-psychotic medication
- •Haemodynamically not stable
结局指标
主要结局
Pain score using the Numeric Rating Scale (NRS)
时间窗: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.
Mean score of pain level (1-3 = mild; 4-6 = moderate; 7-10 = severe)
Brief Pain Inventory (BPI)
时间窗: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.
Worst, least and average pain in the last 24 hours
Anxiety score using the Generalized Anxiety Disorder-7 (GAD-7)
时间窗: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.
Mean score of anxiety level (0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 severe anxiety)
次要结局
- Respiratory Rate(The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery)
- Systolic and diastolic Blood pressure(The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery)
- Oxygen saturation(The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery)
- Opioid dosage(48 hours post surgery)
- Pro-inflammatory cytokine Interleukin 6 (IL-6)(The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery)
- Cortisol level(The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery)
- Heart Rate(The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery)
研究者
PRI CHASKAR
Postgraduate student
Universiti Putra Malaysia