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The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

Primary Purpose

Anxiety, Music, Preoperative

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Music
Sponsored by
Tribhuvan University Teaching Hospital, Institute Of Medicine.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring anxiety, music, preoperative

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Maharajgunj medical campus, TUTH

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group B (control)

Group A (music intervention)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The effect of music therapy on preoperative anxiety in elective surgery
systolic blood pressure
The effect of music therapy on preoperative anxiety in elective surgery
Diastolic blood pressure
The effect of music therapy on preoperative anxiety in elective surgery
mean arterial pressure
The effect of music therapy on preoperative anxiety in elective surgery
heart rate

Full Information

First Posted
March 19, 2021
Last Updated
July 10, 2021
Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
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1. Study Identification

Unique Protocol Identification Number
NCT04813978
Brief Title
The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery
Official Title
The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Music, Preoperative
Keywords
anxiety, music, preoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Researcher provides music to one group and other group will not receive music. medical officer will assess anxiety by using Beck's Anxiety Inventory.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B (control)
Arm Type
No Intervention
Arm Description
Head phone will be placed and music will not be played, will get normal nursing care
Arm Title
Group A (music intervention)
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Music
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effect of music therapy on preoperative anxiety in elective surgery
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The effect of music therapy on preoperative anxiety in elective surgery
Description
systolic blood pressure
Time Frame
6 months
Title
The effect of music therapy on preoperative anxiety in elective surgery
Description
Diastolic blood pressure
Time Frame
6 months
Title
The effect of music therapy on preoperative anxiety in elective surgery
Description
mean arterial pressure
Time Frame
6 months
Title
The effect of music therapy on preoperative anxiety in elective surgery
Description
heart rate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Shrestha, MD
Organizational Affiliation
TUTH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bibhush Shrestha, MD
Organizational Affiliation
MCVTC,IOM
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ninadini Shrestha, MD
Organizational Affiliation
TUTH
Official's Role
Study Director
Facility Information:
Facility Name
Maharajgunj medical campus, TUTH
City
Kathmandu
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29624026
Citation
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.
Results Reference
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PubMed Identifier
29753446
Citation
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.
Results Reference
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PubMed Identifier
24731896
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.
Results Reference
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PubMed Identifier
28434475
Citation
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.
Results Reference
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PubMed Identifier
3204199
Citation
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.
Results Reference
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PubMed Identifier
30401475
Citation
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Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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Citation
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.
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Citation
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Citation
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Results Reference
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The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

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