Investigation of the Effects of Music on Anxiety During Operations Under Spinal Anaesthesia at an Hospital in Cambodia
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
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Phnom Penh、柬埔寨
- Children's Surgical Centre
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Music group
Will receive music during the operation conducted under spinal anaesthesia
|
Played through headphones during the operation under spinal anaesthesia
|
|
无干预：Control group
Will not receive music during the operation conducted under spinal anaesthesia
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in intra-operative anxiety scores
大体时间：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
|
Calculated between scores recorded at the start of the operation and 30 minutes into the procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of patient's in the music group who felt that music made the experience better, worse or had no effect.
大体时间：Within 4 hours post operation
|
Questionnaire asked verbally.
What effect do you think music had on your experience during surgery?
a) made it better b)made it worse c)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.
大体时间：Within 4 hours post operation
|
Questionnaire asked verbally.
Would you recommend listening to music during an operation to other people?
a)yes b)no c) don't 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.
大体时间：Within 4 hours post operation
|
What effect do you think music would have had on your experience during surgery?
a) made it better b)made it worse c)no effect.
|
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.
大体时间：Within 4 hours post operation
|
Questionnaire asked verbally.
Would you like to listen to music if you were to have another operation?
a)yes b)no c) don't know
|
Within 4 hours post operation
|
|
Percentage of anaesthetic providers that experience problems due to music.
大体时间：Within 4 hours post operation
|
Questionnaire on data collection form.
Do you think that the music caused any problems during the operation?
a)yes b)no c)maybe
|
Within 4 hours post operation
|
合作者和调查者
调查人员
- 首席研究员：Joseph T Larvin, BMBCH、Children's Surgical Centre, Phnom Penh, Cambodia
- 首席研究员：SOKHALAY L SUOS, MD、Children's Surgical Centre, Phnom Penh, Cambodia
出版物和有用的链接
一般刊物
- Norris W, Baird WL. Pre-operative anxiety: a study of the incidence and aetiology. Br J Anaesth. 1967 Jun;39(6):503-9. doi: 10.1093/bja/39.6.503. No abstract available.
- Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Risk factors for postoperative anxiety in adults. Anaesthesia. 2001 Aug;56(8):720-8. doi: 10.1046/j.1365-2044.2001.01842.x.
- Wilson CJ, Mitchelson AJ, Tzeng TH, El-Othmani MM, Saleh J, Vasdev S, LaMontagne HJ, Saleh KJ. Caring for the surgically anxious patient: a review of the interventions and a guide to optimizing surgical outcomes. Am J Surg. 2016 Jul;212(1):151-9. doi: 10.1016/j.amjsurg.2015.03.023. Epub 2015 Jun 2.
- Jlala HA, Bedforth NM, Hardman JG. Anesthesiologists' perception of patients' anxiety under regional anesthesia. Local Reg Anesth. 2010;3:65-71. doi: 10.2147/lra.s11271. Epub 2010 Aug 12.
- Wu PY, Huang ML, Lee WP, Wang C, Shih WM. Effects of music listening on anxiety and physiological responses in patients undergoing awake craniotomy. Complement Ther Med. 2017 Jun;32:56-60. doi: 10.1016/j.ctim.2017.03.007. Epub 2017 Mar 31.
- Zengin S, Kabul S, Al B, Sarcan E, Dogan M, Yildirim C. Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complement Ther Med. 2013 Dec;21(6):689-96. doi: 10.1016/j.ctim.2013.08.017. Epub 2013 Sep 1.
- Costa A, Montalbano LM, Orlando A, Ingoglia C, Linea C, Giunta M, Mancuso A, Mocciaro F, Bellingardo R, Tine F, D'Amico G. Music for colonoscopy: A single-blind randomized controlled trial. Dig Liver Dis. 2010 Dec;42(12):871-6. doi: 10.1016/j.dld.2010.03.016. Epub 2010 May 7.
- Pittman S, Kridli S. Music intervention and preoperative anxiety: an integrative review. Int Nurs Rev. 2011 Jun;58(2):157-63. doi: 10.1111/j.1466-7657.2011.00888.x. Epub 2011 Feb 15.
- Tan X, Yowler CJ, Super DM, Fratianne RB. The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial. J Burn Care Res. 2010 Jul-Aug;31(4):590-7. doi: 10.1097/BCR.0b013e3181e4d71b.
- Wang SM, Kulkarni L, Dolev J, Kain ZN. Music and preoperative anxiety: a randomized, controlled study. Anesth Analg. 2002 Jun;94(6):1489-94, table of contents. doi: 10.1097/00000539-200206000-00021.
- McClurkin SL, Smith CD. The Duration of Self-Selected Music Needed to Reduce Preoperative Anxiety. J Perianesth Nurs. 2016 Jun;31(3):196-208. doi: 10.1016/j.jopan.2014.05.017. Epub 2016 Feb 24.
- Mingir T, Ervatan Z, Turgut N. Spinal Anaesthesia and Perioperative Anxiety. Turk J Anaesthesiol Reanim. 2014 Aug;42(4):190-5. doi: 10.5152/TJAR.2014.99705. Epub 2014 May 29.
- Lee WP, Wu PY, Lee MY, Ho LH, Shih WM. Music listening alleviates anxiety and physiological responses in patients receiving spinal anesthesia. Complement Ther Med. 2017 Apr;31:8-13. doi: 10.1016/j.ctim.2016.12.006. Epub 2017 Jan 7.
- Lepage C, Drolet P, Girard M, Grenier Y, DeGagne R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6. doi: 10.1097/00000539-200110000-00022.
- Maeyama A, Kodaka M, Miyao H. [Effect of the music-therapy under spinal anesthesia]. Masui. 2009 Jun;58(6):684-91. Japanese.
- Elkins G, Staniunas R, Rajab MH, Marcus J, Snyder T. Use of a numeric visual analog anxiety scale among patients undergoing colorectal surgery. Clin Nurs Res. 2004 Aug;13(3):237-44. doi: 10.1177/1054773803262222.
- Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.
- Seponski DM, Lahar CJ, Khann S, Kao S, Schunert T. Four decades following the Khmer rouge: sociodemographic factors impacting depression, anxiety and PTSD in Cambodia. J Ment Health. 2019 Apr;28(2):175-180. doi: 10.1080/09638237.2018.1466039. Epub 2018 May 7.
- Alfredsson M, San Sebastian M, Jeghannathan B. Attitudes towards mental health and the integration of mental health services into primary health care: a cross-sectional survey among health-care workers in Lvea Em District, Cambodia. Glob Health Action. 2017;10(1):1331579. doi: 10.1080/16549716.2017.1331579.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 知情同意书 (ICF)
- 临床研究报告（CSR）
- 解析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Music的临床试验
-
University of Alabama at BirminghamThe Craig H. Neilsen Foundation; Lakeshore Foundation完全的
-
Fondation Oeuvre de la Croix Saint-Simon撤销
-
Assistance Publique - Hôpitaux de Paris尚未招聘疼痛 | 疼痛，术后 | 焦虑 | 胸外科 | 疼痛，胸部 | 术后焦虑