Trials / Completed
CompletedNCT03269929
Comparison Between Efficacy of Music Therapy and Intravenous Midazolam 0.02 mg/kgBW in Reducing Preoperative Anxiety
Comparison Between Music Therapy and Intravenous Midazolam 0,02 mg/kgBW in Reducing Preoperative Anxiety: Study on Patient Undergoing Brachytherapy With Spinal Anesthesia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Indonesia University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Music therapy | Subjects listened to music for 30 minutes before undergoing brachytherapy with spinal anesthesia |
| DRUG | Midazolam | Subjects received intravenous midazolam 0,02 mg/kgBW injection before undergoing brachytherapy with spinal anesthesia |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2017-03-31
- Completion
- 2017-07-01
- First posted
- 2017-09-01
- Last updated
- 2017-09-01
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT03269929. Inclusion in this directory is not an endorsement.