Comparison Between Efficacy of Music Therapy and Intravenous Midazolam 0.02 mg/kgBW in Reducing Preoperative Anxiety

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Music therapy; Drug: Midazolam

• Registration Number: NCT03269929
• Lead Sponsor: Indonesia University

Brief Summary

This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia

Detailed Description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Intravenous (IV) cannula had been set and The Amsterdam Preoperative Anxiety and Information (APAIS) score questionnaire was filled by the subject. Blood pressure, pulse rate, and mean arterial pressure were recorded. Subjects were then randomized into two groups (music therapy and midazolam). In music therapy group, subjects listened to music using headphone attached to music player for 30 minutes. Music player has been filled with variety of slow beat songs (60 - 80 BPM), including instrumental, pop, jazz, classical, and so forth. In midazolam group, subjects was given intravenous midazolam 0,02 mg/kgBW injection without listening to music. After injection, subjects are allowed to rest or sleep for 30 minutes. After intervention, APAIS score was filled by subjects with blood pressure, pulse rate, and mean arterial pressure recorded again. Subjects then were moved to brachytherapy room.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-07-01
• Study First Submitted: 2017-07-19
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Woman aged 18-65 years old
• Undergoing one day care brachtherapy with spinal anesthesia
• American Society of Anesthesiologist (ASA) physical status of I-III
• Agreed to participate in this study and signed informed consent
• Able to read, write, and speak in Indonesian language.

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Exclusion Criteria

• Subjects with severe hearing impairment
• Subjects with cognitive/mental impairment based on medical record
• Subjects with previous routine use of antipsychotic and benzodiazepine drug
• Subjects with prior heart disease or uncontrolled hypertension.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music therapy	Music therapy	-
Midazolam	Midazolam	-

Primary Outcome Measures

Name	Time	Method
APAIS score	Day 1
Pulse rate	Day 1
Blood pressure	Day 1
Mean Arterial Pressure	Day 1

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Central Jakarta, DKI Jakarta, Indonesia