The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

Not Applicable

Completed

• Conditions: Preoperative; Anxiety; Music
• Interventions: Other: Music

• Registration Number: NCT04813978
• Lead Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

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 Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-21
• Study First Posted: 2021-03-24
• Study Start: 2021-04-08
• Primary Completion: 2021-05-07
• Status Verified: 2021-07
• Study Completion: 2021-07-01
• Last Update Submitted: 2021-07-10
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (music intervention)	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.

Primary Outcome Measures

Name	Time	Method
The effect of music therapy on preoperative anxiety in elective surgery	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 Outcome Measures

Name	Time	Method
The effect of music therapy on preoperative anxiety in elective surgery	6 months	heart rate

Trial Locations

Locations (1)

Maharajgunj medical campus, TUTH; 🇳🇵 Kathmandu, Nepal