The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

July 10, 2021 updated by: SURAJ NAMLEWAR, Tribhuvan University Teaching Hospital, Institute Of Medicine.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Kathmandu, Nepal
        • Maharajgunj medical campus, TUTH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group B (control)
Head phone will be placed and music will not be played, will get normal nursing care
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of music therapy on preoperative anxiety in elective surgery
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of music therapy on preoperative anxiety in elective surgery
Time Frame: 6 months
systolic blood pressure
6 months
The effect of music therapy on preoperative anxiety in elective surgery
Time Frame: 6 months
Diastolic blood pressure
6 months
The effect of music therapy on preoperative anxiety in elective surgery
Time Frame: 6 months
mean arterial pressure
6 months
The effect of music therapy on preoperative anxiety in elective surgery
Time Frame: 6 months
heart rate
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Investigators

  • Study Director: Anil Shrestha, MD, TUTH
  • Study Director: Bibhush Shrestha, MD, MCVTC,IOM
  • Study Director: Ninadini Shrestha, MD, TUTH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2021

Primary Completion (Actual)

May 7, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 21, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 10, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNAMLEWAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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