Clinical trial NCT03269929: Comparison Between Efficacy of Music Therapy and Intravenous Midazolam 0.02 mg/kgBW in Reducing Preoperative Anxiety
Official title: Comparison Between Music Therapy and Intravenous Midazolam 0,02 mg/kgBW in Reducing Preoperative Anxiety: Study on Patient Undergoing Brachytherapy With Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: APAIS score
timeFrame: Day 1
measure: Blood pressure
timeFrame: Day 1
measure: Pulse rate
timeFrame: Day 1
measure: Mean Arterial Pressure
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Central Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
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