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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
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Music focused on measuring music, anxiety, digestive tract endoscopy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 14, 2018
    Last Updated
    August 20, 2018
    Sponsor
    National Defense Medical Center, Taiwan
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    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

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

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