The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

NCT04813978 | Completed DMC

• 1 other identifier: SNAMLEWAR
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Anxiety is a common phenomenon among patients who are undergoing surgery. It is a condition characterized by stress, nervousness, fear, unpleasant feeling, and higher activity of Autonomic Nervous System. The current studies demonstrated that listening to music, reduces anxiety levels.

Conditions

Anxiety; Music; Preoperative

Keywords

anxiety; music; preoperative

Outcome Measures

Primary Outcomes (1)

• The effect of music therapy on preoperative anxiety in elective surgery

  preoperative anxiety will be assessed by using Beck's Anxiety Inventory in one group and the other group will only get routine nursing care.The total score for all 21 symptoms can range between 0 and 63 points. A total score of 0 - 7 is interpreted as "Minimal" level of anxiety, 8 - 15 as "Mild"; 16 - 25 as "Moderate" and 26 - 63 as "Severe" level of anxiety. More the score greater the anxiety.

  6 months

Secondary Outcomes (4)

• The effect of music therapy on preoperative anxiety in elective surgery

  6 months

• The effect of music therapy on preoperative anxiety in elective surgery

  6 months

• The effect of music therapy on preoperative anxiety in elective surgery

  6 months

• The effect of music therapy on preoperative anxiety in elective surgery

  6 months

Study Arms (2)

Group B (control)

NO INTERVENTION

Head phone will be placed and music will not be played, will get normal nursing care

Group A (music intervention)

EXPERIMENTAL

For the interventional group, in addition to normal nursing care, patients will listen to instrumental relaxing music genre consist of pitch, rhythm and tone color for 30 minutes pre-operatively, using mp3 player and over-ear headphones to reduce outside interference, at a volume of the patient's preference.

Other: Music

Interventions

Music OTHER

For the interventional group, in addition to normal nursing care, patients will listen to instrumental relaxing music genre consist of pitch, rhythm and tone color for 30 minutes pre-operatively, using mp3 player and over-ear headphones to reduce outside interference, at a volume of the patient's preference.

Group A (music intervention)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years scheduled for elective surgery
• American Society of Anaesthesiologists Physical Status I, II

You may not qualify if:

• Patient's refusal
• Patient's with known auditory disability
• Psychiatric disorder
• Altered mental status
• Patients routinely taking CNS depressant drugs (eg : Diazepam, Clonazepam)

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Maharajgunj medical campus, TUTH

Kathmandu, Nepal

Location

Related Publications (12)

• Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.

  PMID: 29624026 BACKGROUND

• Tulloch I, Rubin JS. Assessment and Management of Preoperative Anxiety. J Voice. 2019 Sep;33(5):691-696. doi: 10.1016/j.jvoice.2018.02.008. Epub 2018 May 9.

  PMID: 29753446 BACKGROUND

• 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.

  PMID: 24731896 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

• Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

  PMID: 3204199 BACKGROUND

• Lemos MF, Lemos-Neto SV, Barrucand L, Vercosa N, Tibirica E. [Preoperative education reduces preoperative anxiety in cancer patients undergoing surgery: Usefulness of the self-reported Beck anxiety inventory]. Braz J Anesthesiol. 2019 Jan-Feb;69(1):1-6. doi: 10.1016/j.bjan.2018.07.003. Epub 2018 Nov 3.

  PMID: 30401475 BACKGROUND

• Franzoi MA, Goulart CB, Lara EO, Martins G. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial. Rev Lat Am Enfermagem. 2016 Dec 19;24:e2841. doi: 10.1590/1518-8345.1121.2841.

  PMID: 27992027 BACKGROUND

• 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.

  PMID: 23953858 BACKGROUND

• Wang Y, Dong Y, Li Y. Perioperative psychological and music interventions in elderly patients undergoing spinal anesthesia: effect on anxiety, heart rate variability, and postoperative pain. Yonsei Med J. 2014 Jul;55(4):1101-5. doi: 10.3349/ymj.2014.55.4.1101.

  PMID: 24954343 BACKGROUND

• Ottaviani S, Bernard JL, Bardin T, Richette P. Effect of music on anxiety and pain during joint lavage for knee osteoarthritis. Clin Rheumatol. 2012 Mar;31(3):531-4. doi: 10.1007/s10067-011-1925-9. Epub 2011 Dec 30.

  PMID: 22207250 BACKGROUND

• Ni CH, Tsai WH, Lee LM, Kao CC, Chen YC. Minimising preoperative anxiety with music for day surgery patients - a randomised clinical trial. J Clin Nurs. 2012 Mar;21(5-6):620-5. doi: 10.1111/j.1365-2702.2010.03466.x. Epub 2011 Feb 20.

  PMID: 21332853 BACKGROUND

• Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: a report by the American Society of Anesthesiologist Task Force on Preoperative Fasting. Anesthesiology. 1999 Mar;90(3):896-905. doi: 10.1097/00000542-199903000-00034. No abstract available.

  PMID: 10078693 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

• Anil Shrestha, MD

  TUTH

  STUDY DIRECTOR

• Bibhush Shrestha, MD

  MCVTC,IOM

  STUDY DIRECTOR

• Ninadini Shrestha, MD

  TUTH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Researcher provides music to one group and other group will not receive music. medical officer will assess anxiety by using Beck's Anxiety Inventory.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 24, 2021
• Study Start: April 8, 2021
• Primary Completion: May 7, 2021
• Study Completion: July 1, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)