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Clinical Trials/NCT03642015
NCT03642015CompletedNot Applicable

The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures

National Defense Medical Center, Taiwan0 sites200 target enrollmentStarted: July 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
200
Primary Endpoint
Change from Baseline Anxiety after intervention immediately

Study Overview

Brief Summary

This study investigated the effect of listening to self-selected music on anxiety and physiological responses in patients prior to gastroscopy. A randomized controlled trial was conducted, in which patients scheduled for gastroscopy in a medical center located in Taipei, Taiwan, were enrolled. The experimental group listened to self-selected music with earphones for 15 min before the procedure, whereas the control group rested for 15 min. Blood pressure (BP), heart rate, respiratory rate, and anxiety level were measured immediately before and after the intervention.

Detailed Description

Potential study patients were referred from physicians. The research assistant described the study's purpose and procedure to the patients and explained their right to refuse or withdraw from the study without jeopardizing their procedure. In addition, the privacy of each patient's data was ensured by storing the data in a file that required a password to access. Personal identification was by no means included in the data file. In addition, the participants were assured that their data would not be used for purposes other than this research.

After obtaining their consent, the participants were randomly assigned into the music group or the control group by drawing lots. We brought the participants to a separate and quiet room in the waiting area to prevent environmental interference. First, the participants completed the study questionnaire; then, the research investigator measured their physiological parameters. The participants in the music group selected the music they preferred from different genres, namely Chinese pop, Taiwanese songs, western classical , light music, western pop, and nostalgic music. If a participant had no particular preference, music with a low tone, regular rhythm (approximately 60-80 beats per minute), and soft melody (light music, 5%) was used, as recommended by a previous study. During the 15-min intervention period before the gastroscopy procedure, the experimental group rested by listening to music and sitting on a comfortable chair, whereas the control group rested only by sitting on a comfortable chair. After the 15-min intervention, the patients' anxiety and physiological parameters were reassessed.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 20 years of age or older
  • able to respond to questionnaires in Chinese. were excluded from the study.

Exclusion Criteria

  • with hearing loss who did not wear hearing aids
  • patients who were unable to communicate verbally
  • patients diagnosed with dementia, mental illness defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, or cognitive impairment

Arms & Interventions

listening music

Experimental

The participants in the music group selected the music they preferred from different genres. During the 15-min intervention period before the gastroscopy procedure, the experimental group rested by listening to music and sitting on a comfortable chair

Intervention: Music listening (Behavioral)

Control

No Intervention

control group rested only by sitting on a comfortable chair

Outcomes

Primary Outcomes

Change from Baseline Anxiety after intervention immediately

Time Frame: baseline, 15 minute

Anxiety was measured using the Chinese version of the 20-item State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), which demonstrated high reliability (Cronbach's alpha of 0.91) in patients with anxiety disorders.32 Total scores for state anxiety ranged from 20 to 80; higher scores indicated higher levels of anxiety.

Secondary Outcomes

  • Change from Baseline Respiratory Rate after intervention immediately(baseline, 15 minute)
  • Change from Baseline Heart Rate after intervention immediately(baseline, 15 minute)
  • Change from Baseline Blood pressure after intervention immediately(baseline, 15 minute)

Investigators

Sponsor
National Defense Medical Center, Taiwan
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yang Chia Chen

Principal Investigator

National Defense Medical Center, Taiwan

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