Investigation of the Effects of Music on Anxiety During Operations Under Spinal Anaesthesia at an Hospital in Cambodia

NCT04169971 | Completed

• 1 other identifier: musicduringspinal1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Anxiety

Keywords

trial; Anxiety; music; intraoperative period; spinal anaesthesia

Outcome Measures

Primary Outcomes (1)

• Change in intra-operative anxiety scores

  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

Secondary Outcomes (5)

• 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 control group who felt that music would have made their experience better, worse or the same.

  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 anaesthetic providers that experience problems due to music.

  Within 4 hours post operation

Study Arms (2)

Music group

EXPERIMENTAL

Will receive music during the operation conducted under spinal anaesthesia

Other: Music

Control group

NO INTERVENTION

Will not receive music during the operation conducted under spinal anaesthesia

Interventions

Music OTHER

Played through headphones during the operation under spinal anaesthesia

Music group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Surgical Center, Cambodia: lead

Study Sites (1)

Children's Surgical Centre

Phnom Penh, Cambodia

Location

Related Publications (19)

• 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.

  PMID: 6027959 BACKGROUND

• 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.

  PMID: 11493233 BACKGROUND

• 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.

  PMID: 26138522 BACKGROUND

• 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.

  PMID: 22915871 BACKGROUND

• 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.

  PMID: 28619305 BACKGROUND

• 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.

  PMID: 24280479 BACKGROUND

• 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.

  PMID: 20452299 BACKGROUND

• 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.

  PMID: 21554287 BACKGROUND

• 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.

  PMID: 20498613 BACKGROUND

• 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.

  PMID: 12032013 BACKGROUND

• 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.

  PMID: 27235956 BACKGROUND

• 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.

  PMID: 27366419 BACKGROUND

• 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.

  PMID: 28434475 BACKGROUND

• 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.

  PMID: 11574356 BACKGROUND

• Maeyama A, Kodaka M, Miyao H. [Effect of the music-therapy under spinal anesthesia]. Masui. 2009 Jun;58(6):684-91. Japanese.

  PMID: 19522258 BACKGROUND

• 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.

  PMID: 15245638 BACKGROUND

• 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.

  PMID: 10702461 BACKGROUND

• 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.

  PMID: 29733242 BACKGROUND

• 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.

  PMID: 29261452 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joseph T Larvin, BMBCH

  Children's Surgical Centre, Phnom Penh, Cambodia

  PRINCIPAL INVESTIGATOR

• SOKHALAY L SUOS, MD

  Children's Surgical Centre, Phnom Penh, Cambodia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-centre, prospective, randomised controlled trial. Patients will be invited to participate if they are due to undergo a procedure for which they will require spinal anaesthesia and if they meet the inclusion criteria and none of the exclusion criteria. They will not be required to make any additional hospital visits and will be asked to give their informed consent prior to the procedure. Half of the participants will receive music from the start of surgery until completion of the operation and the other half will serve as the 'control group' and will receive no headphones or music. The anxiety of participant's during the operation will be assessed through a VAS and they will be asked questions about their experience afterwards. The anxiety scores from the two groups will be compared, as will their responses to the questions about their experience, in order to elucidate whether the music produced any differences in anxiety or experience.

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 20, 2019
• Study Start: October 28, 2019
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after recruitment of last participant.
• Access Criteria: Requests will be reviewed by an independent review panel and all requestors will be required to sign a data access agreement.

Locations

CA (1)