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OpenTrials
Completed

NCT Number: NCT03269929

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital

Central Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

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.

Treatment and study plan

Music Therapy

Other

Subjects listened to music for 30 minutes before undergoing brachytherapy with spinal anesthesia

midazolam

Drug

Subjects received intravenous midazolam 0,02 mg/kgBW injection before undergoing brachytherapy with spinal anesthesia

Primary outcomes

  1. APAIS score

    Time frame: Day 1

  2. Blood pressure

    Time frame: Day 1

  3. Pulse rate

    Time frame: Day 1

  4. Mean Arterial Pressure

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison Between Music Therapy and Intravenous Midazolam 0,02 mg/kgBW in Reducing Preoperative Anxiety: Study on Patient Undergoing Brachytherapy With Spinal Anesthesia

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 1, 2017
Registry last updated
Sep 1, 2017

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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