Effect of Music in Intraoperative Period

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485650
• Other study ID #: AIBU-AML-UY-01
• Status: Completed
• Phase: N/A
• Start date: February 24, 2017
• Est. completion date: May 30, 2017

Study information

• Verified date: July 2020
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 30, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Music Therapy
• Pain, Postoperative
• Perioperative Care
• Postoperative Pain
• Spinal Anesthesia
• Total Knee Arthroplasty
• Vital Signs

Intervention

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.
• 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
• non-sedated group
The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30

Locations

Country	Name	City	State
Turkey	Faculty of health sciences	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (26)

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. — View Citation

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. — View Citation

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. Review. Erratum in: AORN J. 2010 Dec;92(6):708. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Eti Aslan F. The assessment methods of pain. Journal of Cumhuriyet University School of Nursing. 2002;6:9-16.

Gursoy A A. Anxiety Levels of Preoperative Patients and Determining the Factors That May Cause Anxiety. Journal of Nursing Research. 2001;1:23-29.

Ilkkaya NK, Ustun FE, Sener EB, Kaya C, Ustun YB, Koksal E, Kocamanoglu IS, Ozkan F. The effects of music, white noise, and ambient noise on sedation and anxiety in patients under spinal anesthesia during surgery. J Perianesth Nurs. 2014 Oct;29(5):418-26. doi: 10.1016/j.jopan.2014.05.008. — View Citation

Jiménez-Jiménez M, García-Escalona A, Martín-López 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. — View Citation

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.

Kömürcü E, Kiraz HA, Kaymaz B, Gölge UH, Nusran G, Göksel F, Sahin H, Ömür 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. — View Citation

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. — View Citation

Lepage C, Drolet P, Girard M, Grenier Y, DeGagné R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6. — View Citation

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. — View Citation

Özdemir Ü, 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. — View Citation

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.

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. — View Citation

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. — View Citation

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

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. Review. Turkish. — View Citation

Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. Review. — View Citation

Yilmaz E, Aydin E. The Effect of Pre and Postoperative Anxiety in Quality of Recovery in Patients Undergoing Surgery. Firat Health Services Journal. 2013;8:79-95.

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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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