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

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ClinicalTrials.gov Identifier: NCT03269929
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Christopher Kapuangan, Indonesia University

Study Description
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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

Condition or disease Intervention/treatment Phase
Cancer Other: Music therapy Drug: Midazolam Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Music therapy Other: Music therapy
Subjects listened to music for 30 minutes before undergoing brachytherapy with spinal anesthesia
Active Comparator: Midazolam Drug: Midazolam
Subjects received intravenous midazolam 0,02 mg/kgBW injection before undergoing brachytherapy with spinal anesthesia


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269929


Locations
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Indonesia
Cipto Mangunkusumo Central National Hospital
Central Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
More Information
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Additional Information:

Publications:

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Responsible Party: Christopher Kapuangan, Anesthesiologist, Indonesia University
ClinicalTrials.gov Identifier: NCT03269929    
Other Study ID Numbers: IndonesiaUAnes018
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action