- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03642015
The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: listening music
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
|
listening the music 15 min
|
No Intervention: Control
control group rested only by sitting on a comfortable chair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline, 15 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Blood pressure after intervention immediately
Time Frame: baseline, 15 minute
|
Blood Pressure was measured using a calibrated sphygmomanometer with an appropriately sized cuff.
|
baseline, 15 minute
|
Change from Baseline Heart Rate after intervention immediately
Time Frame: baseline, 15 minute
|
Heart rate was measured through 1-min radial artery pulse counting.
|
baseline, 15 minute
|
Change from Baseline Respiratory Rate after intervention immediately
Time Frame: baseline, 15 minute
|
Respiratory rate was determined by counting the number of breaths per minute during quiet breathing.
|
baseline, 15 minute
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TSGH-C97-151
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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