The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

Study Overview
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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.

Official Title
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The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

Conditions
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Anxiety, Preoperative, Music

Intervention / Treatment
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* Other: Music


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group B (control)<br>Head phone will be placed and music will not be played, will get normal nursing care | |
| Experimental: Group A (music intervention)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, music, preoperative