Effect of Music in Intraoperative Period

The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial

Background and Aims: Music therapy has a wide range of uses in health care practice. The aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status.

Methods: The study was performed in an operating room with a total of 90 patients, of whom 30 were in the music group, 30 were in the control group and 30 were in the sedated group. The ethics committee's approval, institutional permission, and the study participants' written informed consent were obtained. Data were collected using patient information and intraoperative observation form for vital signs as well as through the Visual Analog Scale and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Anxiety; Spinal Anesthesia; Perioperative Care; Total Knee Arthroplasty; Music Therapy; Vital Signs
• Intervention / Treatment: Other: music therapy; Other: sedated group; Other: non-sedated group

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bolu, Turkey
    • Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patients that had an orthopedic operation
• The patients who took spinal anesthesia
• able to understand, read and speak Turkish, so they may complete the informed consent and questionaires
• Aged 18 or older
• Have a Body Mass Index (BMI) <40
• ASA (American Society of Anaesthesiologists) I-II-III statuses.

Exclusion Criteria:

• Patients with vision and hearing problems and inability to complete questionnaires,
• The patients not have psychiatric disease history and psychiatric drug use,
• The patients not have diseases that could be evaluated as severe (such as heart, kidney, liver failure)
• The patients not underwent emergency surgeries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music group; The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. The number of participants:30	Other: music therapy; The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group.
Active Comparator: Sedated group; Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30	Other: sedated group; Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30
Other: Non-sedated group; The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30	Other: non-sedated group; The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups	Measurement of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups	Change from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Distribution of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups	Measurement of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups	Change from Baselinebdiastolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups	Measurement of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups	Change from Baseline pulse rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Distribution of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups	Measurement of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups	Change from Baseline of patients respiratory rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
anxiety assessment 30 minutes before surgery	State- Trait Anxiety Scale was applied to all three groups in preoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)	State- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgery
anxiety assessment 8 hours after surgery	State- Trait Anxiety Scale was applied to all three groups in postoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)	State- Trait Anxiety Scale was applied to all three groups in 8 hours after surgery
pain assessment in the operating room	The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain	The pain was assessed at the end of the operation in 10 minutes with numerical pain scale
Postoperative pain at 1 hours	The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain.	The pain was assessed followed at 1 hours postoperative period with numerical pain scale
Postoperative pain at 8 hours	The pain was assessed with numerical pain. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0)	The pain was assessed followed at 8 hours postoperative period with numerical pain scale

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University
• Investigators: Principal Investigator: ümmühan yiğit, msc, Research Assistant; Principal Investigator: arzu ilçe, proffesor, faculty of health science of dean; Principal Investigator: ibrahim karagöz, phd, anesthesiology and reanimation doctor

Publications and helpful links

General Publications

• 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.
• Chou MH, Lin MF. Exploring the listening experiences during guided imagery and music therapy of outpatients with depression. J Nurs Res. 2006 Jun;14(2):93-102. doi: 10.1097/01.jnr.0000387567.41941.14.
• Bae I, Lim HM, Hur MH, Lee M. Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complement Ther Med. 2014 Apr;22(2):251-7. doi: 10.1016/j.ctim.2014.02.002. Epub 2014 Feb 23.
• Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth. 2002 Oct;49(8):792-8. doi: 10.1007/BF03017410.
• Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.
• Liu Y, Petrini MA. Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. Complement Ther Med. 2015 Oct;23(5):714-8. doi: 10.1016/j.ctim.2015.08.002. Epub 2015 Aug 4.
• Koc H, Erk G, Apaydin Y, Horasanli E, Yigitbasi B, Dikmen B. The Effects of Classical Turkish Music on Patients Undergoing Inguinal Hernia Repair under Epidural Anesthesia. Turk Anaesth Int Care. 2009;37:366-373.
• Sener EB, Koylu N, Ustun FE, Kocamanoglu S, Ozkan F. The effects of music, white noise and operating room noise on perioperative anxiety in patients under spinal anesthesia. European Journal Of Anaesthesiology (EJA). 2010;24:133
• Uyar M, Akin Korhan E. [The effect of music therapy on pain and anxiety in intensive care patients]. Agri. 2011 Oct;23(4):139-46. doi: 10.5505/agri.2011.94695. Turkish.
• Bansal P, Kharrod U, Sanwatsarkar S, Patel H, Kamat H. The Effect Of Music Therapy On Sedative Requirements And Haemodynamic Parameters In Patients Under Spinal Anaesthesia; A Prospective Study. Journal Of Clinical And Diagnostic Research. 2010;4:2782-2789.
• Allen K, Golden LH, Izzo JL Jr, Ching MI, Forrest A, Niles CR, Niswander PR, Barlow JC. Normalization of hypertensive responses during ambulatory surgical stress by perioperative music. Psychosom Med. 2001 May-Jun;63(3):487-92. doi: 10.1097/00006842-200105000-00019.
• Komurcu E, Kiraz HA, Kaymaz B, Golge UH, Nusran G, Goksel F, Sahin H, Omur D, Hanci V. The effect of intraoperative sounds of saw and hammer on psychological condition in patients with total knee arthroplasty: prospective randomized study. ScientificWorldJournal. 2015;2015:690569. doi: 10.1155/2015/690569. Epub 2015 Feb 22.
• Sarkar D, Chakraborty K, Bhadra B, Ghorai TK, Singh R, Mandal U. Effects of music on patients undergoing orthopaedic surgery under spinal anaesthesia. IOSR Journal of Dental and Medical Sciences. 2015;14:2279-2861.
• Bailey L. Strategies for decreasing patient anxiety in the perioperative setting. AORN J. 2010 Oct;92(4):445-57; quiz 458-60. doi: 10.1016/j.aorn.2010.04.017. Erratum In: AORN J. 2010 Dec;92(6):708.
• Carr E, Brockbank K, Allen S, Strike P. Patterns and frequency of anxiety in women undergoing gynaecological surgery. J Clin Nurs. 2006 Mar;15(3):341-52. doi: 10.1111/j.1365-2702.2006.01285.x.
• Gursoy A A. Anxiety Levels of Preoperative Patients and Determining the Factors That May Cause Anxiety. Journal of Nursing Research. 2001;1:23-29.
• Turhan Y, Avci R, Ozcengiz D. The Relationship Between Preoperative And Postoperative Anxiety, And Patient Satisfaction In Preparation For Elective Surgery. Journal of Anesthesia. 2012;20:27-33
• Yilmaz E, Aydin E. The Effect of Pre and Postoperative Anxiety in Quality of Recovery in Patients Undergoing Surgery. Fırat Health Services Journal. 2013;8:79-95.
• Eti Aslan F. The assessment methods of pain. Journal of Cumhuriyet University School of Nursing. 2002;6:9-16.
• Shek DT. The Chinese version of the State-Trait Anxiety Inventory: its relationship to different measures of psychological well-being. J Clin Psychol. 1993 May;49(3):349-58. doi: 10.1002/1097-4679(199305)49:33.0.co;2-j.
• Zhu NN, Xu PP, Lei TT, Sun T, Chan SW. Postoperative Pain Self-Management Behavior in Patients Who Underwent Total Knee or Hip Arthroplasty. AORN J. 2017 Apr;105(4):355-364. doi: 10.1016/j.aorn.2017.02.001.
• Chen HJ, Chen TY, Huang CY, Hsieh YM, Lai HL. Effects of music on psychophysiological responses and opioid dosage in patients undergoing total knee replacement surgery. Jpn J Nurs Sci. 2015 Oct;12(4):309-19. doi: 10.1111/jjns.12070. Epub 2015 Mar 9.
• Sendelbach SE, Halm MA, Doran KA, Miller EH, Gaillard P. Effects of music therapy on physiological and psychological outcomes for patients undergoing cardiac surgery. J Cardiovasc Nurs. 2006 May-Jun;21(3):194-200. doi: 10.1097/00005082-200605000-00007.
• Ozdemir U, Tasci S, Yildizhan E, Aslan S, Eser B. The Effect of Classical Turkish Music on Pain Severity and Anxiety Levels in Patients Undergoing Bone Marrow Aspiration and Biopsy. Pain Manag Nurs. 2019 Feb;20(1):82-87. doi: 10.1016/j.pmn.2018.04.009. Epub 2018 May 18.
• Labrague LJ, McEnroe-Petitte DM. Influence of Music on Preoperative Anxiety and Physiologic Parameters in Women Undergoing Gynecologic Surgery. Clin Nurs Res. 2016 Apr;25(2):157-73. doi: 10.1177/1054773814544168. Epub 2014 Jul 30.
• Jimenez-Jimenez M, Garcia-Escalona A, Martin-Lopez A, De Vera-Vera R, De Haro J. Intraoperative stress and anxiety reduction with music therapy: a controlled randomized clinical trial of efficacy and safety. J Vasc Nurs. 2013 Sep;31(3):101-6. doi: 10.1016/j.jvn.2012.10.002.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Actual): March 15, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: anxiety; music therapy; total knee arthroplasty; postoperative pain; perioperative care; vital signs; spinal aesthesia
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anxiety Disorders
• Other Study ID Numbers: AIBU-AML-UY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: when the planned number of participants was reached, the data were coded in a statistical program and shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No