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Clinical Trials/NCT04813978
NCT04813978CompletedNot Applicable

The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

Tribhuvan University Teaching Hospital, Institute Of Medicine.1 site in 1 country48 target enrollmentStarted: April 8, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
48
Locations
1
Primary Endpoint
The effect of music therapy on preoperative anxiety in elective surgery

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes 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.

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The effect of music therapy on preoperative anxiety in elective surgery(6 months)

Investigators

Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

SURAJ NAMLEWAR

Principal investigator

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Study Sites (1)

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