The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

NCT ID: NCT04813978

Last Updated: 2021-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-08

Study Completion Date

2021-07-01

Brief Summary

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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.

Detailed Description

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Pre-operative anxiety is recognised as a potential and preventable risk factor for post-operative complications. It is estimated that between 25% to 80% of patients admitted to hospital for surgery experience pre-operative anxiety, and anxiety can negatively influence patient recovery.Physiologically pre-operative anxiety can lead to autonomic dysfunction and can modify inflammatory responses, platelet activity, and immunologic functioning. The Beck Anxiety Inventory(BAI), created by Aaron T. Beck is a 21 questions multiple choice self report inventory which measures the severity of an anxiety in adults and adolescents. It has been widely used in clinical research in mental health care mainly to measure general anxiety. 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.

This study aims to compare the alleviation of Pre-operative anxiety in patients undergoing surgery with or without music.

Conditions

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Anxiety Music Preoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Researcher provides music to one group and other group will not receive music. medical officer will assess anxiety by using Beck's Anxiety Inventory.

Study Groups

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Group B (control)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group A (music intervention)

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 Type EXPERIMENTAL

Music

Intervention Type 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.

Interventions

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Music

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER

Sponsor Role lead

Responsible Party

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SURAJ NAMLEWAR

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anil Shrestha, MD

Role: STUDY_DIRECTOR

TUTH

Bibhush Shrestha, MD

Role: STUDY_DIRECTOR

MCVTC,IOM

Ninadini Shrestha, MD

Role: STUDY_DIRECTOR

TUTH

Locations

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Maharajgunj medical campus, TUTH

Kathmandu, , Nepal

Site Status

Countries

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Nepal

References

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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.

Reference Type BACKGROUND
PMID: 29624026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29753446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24731896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28434475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3204199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30401475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27992027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23953858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24954343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22207250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21332853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10078693 (View on PubMed)

Other Identifiers

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SNAMLEWAR

Identifier Type: -

Identifier Source: org_study_id

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