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

University of Indonesia (UI)

Status: Completed

Conditions: Cancer

Treatments: Drug: Midazolam; Other: Music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03269929

IndonesiaUAnes018

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups

Music therapy

Experimental group

Treatment:

Other: Music therapy

Midazolam

Active Comparator group

Treatment:

Drug: Midazolam