The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures
Primary Purpose
Music, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music listening
Sponsored by

About this trial
This is an interventional supportive care trial for Music focused on measuring music, anxiety, digestive tract endoscopy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
listening music
Control
Arm Description
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
control group rested only by sitting on a comfortable chair
Outcomes
Primary Outcome Measures
Change from Baseline Anxiety after intervention immediately
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 Outcome Measures
Change from Baseline Blood pressure after intervention immediately
Blood Pressure was measured using a calibrated sphygmomanometer with an appropriately sized cuff.
Change from Baseline Heart Rate after intervention immediately
Heart rate was measured through 1-min radial artery pulse counting.
Change from Baseline Respiratory Rate after intervention immediately
Respiratory rate was determined by counting the number of breaths per minute during quiet breathing.
Full Information
NCT ID
NCT03642015
First Posted
August 14, 2018
Last Updated
August 20, 2018
Sponsor
National Defense Medical Center, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03642015
Brief Title
The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures
Official Title
The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2008 (Actual)
Primary Completion Date
September 1, 2008 (Actual)
Study Completion Date
June 30, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music, Anxiety
Keywords
music, anxiety, digestive tract endoscopy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
listening music
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
control group rested only by sitting on a comfortable chair
Intervention Type
Behavioral
Intervention Name(s)
Music listening
Intervention Description
listening the music 15 min
Primary Outcome Measure Information:
Title
Change from Baseline Anxiety after intervention immediately
Description
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.
Time Frame
baseline, 15 minute
Secondary Outcome Measure Information:
Title
Change from Baseline Blood pressure after intervention immediately
Description
Blood Pressure was measured using a calibrated sphygmomanometer with an appropriately sized cuff.
Time Frame
baseline, 15 minute
Title
Change from Baseline Heart Rate after intervention immediately
Description
Heart rate was measured through 1-min radial artery pulse counting.
Time Frame
baseline, 15 minute
Title
Change from Baseline Respiratory Rate after intervention immediately
Description
Respiratory rate was determined by counting the number of breaths per minute during quiet breathing.
Time Frame
baseline, 15 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures
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