A Prospective Randomised Controlled Trial to Investigate the Effects of Intra-operative Music on Anxiety Levels During Procedures Under Spinal Anaesthesia at a Surgical Centre in Cambodia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in intra-operative anxiety scores
研究概览
简要总结
This study investigates he effects of intra-operative music on anxiety levels during procedures under spinal anaesthesia at a surgical centre in Cambodia. Participants will be randomly allocated to either the music (M) group or the 'control' (C) group. The M group will receive music played through headphones for the duration of the operation. The C group will receive no music or headphones. Anxiety will be measured in both groups, through a visual analogue scale (VAS), at the beginning of the operation and after 30 minutes of the procedure. Scores will be compared.
详细描述
Background: During operations conducted under spinal anaesthesia patients are aware of their environment, including sounds related to operative instruments and the voices of staff. This has the potential to cause anxiety and amplify existing anxiety which can negatively impact patient experience and outcomes. Research has shown peri-operative music can reduce anxiety but there is no robust evidence for the effect of intraoperative music on intraoperative anxiety.
Objectives: The primary objective is to determine the effects of intraoperative music on intraoperative anxiety levels for patients undergoing procedures conducted under spinal anaesthesia. The secondary objectives are to investigate whether participants feel that music improved/would improve their experience and whether they would choose it in future or recommend it for others.
Methods: This prospective randomised controlled trial will be conducted at the Children's Surgical Centre in Phnom Penh. Participants will be 18 years or over, due to undergo a procedure that requires spinal anaesthesia and not have a medical history that fulfils any of the exclusion criteria. The trial will aim to recruit between 16 and 28 patients consecutively once it commences, and participants will be randomised to either the music (M) group or the 'control' (C) group. The M group will receive music (pre-selected from 5 categories) played through headphones for the duration of the operation. The C group will receive no music or headphones. Anxiety will be measured in both groups, through a visual analogue scale (VAS), at the beginning of the operation and after 30 minutes of the procedure. In the recovery room the participants will be asked two questions relating to experience and future recommendations.
Results: The VAS scores and change in VAS scores will be displayed as mean ± Standard Error and the results from the two groups will be compared using a student's paired t-test or a Mann-Whitney U test depending on the distribution of the data. The results from the post-operation questions will be displayed as frequencies and the answers will be compared using a χ2 test. All tests will be 2-tailed and P<0.05 will be considered significant
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Undergoing a procedure at CSC that requires spinal anaesthesia and spinal anaesthesia is not contra-indicated
- •Gives informed consent to participate in the trial
排除标准
- •Has an existing psychological diagnosis
- •Has auditory impairment
- •Deemed not to have capacity to give consent
- •Sedatives are administered during the procedure
- •General anaesthesia is required during the procedure
结局指标
主要结局
Change in intra-operative anxiety scores
时间窗: Calculated between scores recorded at the start of the operation and 30 minutes into the procedure
Score on 'Anxiety visual analogue scale.' Minimum score 0 representing calm and maximum score 10 representing extreme anxiety
次要结局
- Percentage of anaesthetic providers that experience problems due to music.(Within 4 hours post operation)
- Percentage of patient's in the music group who felt that music made the experience better, worse or had no effect.(Within 4 hours post operation)
- Percentage of patient's in the music group who felt that they would recommend to others, wouldn't recommend to others or did not know.(Within 4 hours post operation)
- Percentage of patient's in the music group who, if they had another operation, would like to listen to music, would not like to listen to music, or did not know.(Within 4 hours post operation)
- Percentage of patient's in the control group who felt that music would have made their experience better, worse or the same.(Within 4 hours post operation)