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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269929
• Other study ID #: IndonesiaUAnes018
• Status: Completed
• Phase: N/A
• First received: July 19, 2017
• Last updated: August 30, 2017
• Start date: January 1, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: August 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Central Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	APAIS score		Day 1
Primary	Blood pressure		Day 1
Primary	Pulse rate		Day 1
Primary	Mean Arterial Pressure		Day 1

External Links

•   15. Armon R, Fisher A, Goldfarb B, Milton C. Effects of music tempos on blood pressure, heart rate, and skin conductance after.