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OpenTrials
Completed

NCT Number: NCT04813978

The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maharajgunj medical campus, TUTH

Kathmandu, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Music

Other

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 outcomes

  1. 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

  1. The effect of music therapy on preoperative anxiety in elective surgery

    Time frame: 6 months

    systolic blood pressure

  2. The effect of music therapy on preoperative anxiety in elective surgery

    Time frame: 6 months

    Diastolic blood pressure

  3. The effect of music therapy on preoperative anxiety in elective surgery

    Time frame: 6 months

    mean arterial pressure

  4. The effect of music therapy on preoperative anxiety in elective surgery

    Time frame: 6 months

    heart rate

Sponsors and collaborators

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2021
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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