MusicNCT03642015
The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures
A study testing Music listening in people with Music and Anxiety, run by National Defense Medical Center, Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- What is being tested?
- Music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2008to 30 Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 years of age or older
- able to respond to questionnaires in Chinese. were excluded from the study.
Who cannot join
- 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
About this study
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.
Read the 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.
- Being tested
- Music listening
- Keywords
- music, anxiety, digestive tract endoscopy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningBehavioural
listening the music 15 min
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Music listening |
| Control | No intervention | control group rested only by sitting on a comfortable chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 15 minute
Secondary outcomes (3)
Change from Baseline Blood pressure after intervention immediately
Blood Pressure was measured using a calibrated sphygmomanometer with an appropriately sized cuff.
Measured: baseline, 15 minute
Change from Baseline Heart Rate after intervention immediately
Heart rate was measured through 1-min radial artery pulse counting.
Measured: baseline, 15 minute
Change from Baseline Respiratory Rate after intervention immediately
Respiratory rate was determined by counting the number of breaths per minute during quiet breathing.
Measured: baseline, 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Jul 2008
- Primary completion1 Sep 2008
- Study completion30 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MusicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Chia Chen, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642015
- Sponsor's protocol ID
- TSGH-C97-151
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures
- ClinicalTrials.gov ID
- NCT03642015
- Acronym / sponsor ID
- TSGH-C97-151
- Keywords
- music, anxiety, digestive tract endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Jul 2008 (actual)
- Primary completion
- 1 Sep 2008 (actual)
- Study completion
- 30 Jun 2009 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| listening music | Experimental | Behavioral: Music listeningThe 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 | No intervention | –control group rested only by sitting on a comfortable chair |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20 years of age or older
- able to respond to questionnaires in Chinese. were excluded from the study.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music listeninglistening the music 15 min | Behavioural | listening music |
Primary outcome
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.
3 secondary outcomes
Change from Baseline Blood pressure after intervention immediately
Time frame: baseline, 15 minute
Change from Baseline Heart Rate after intervention immediately
Time frame: baseline, 15 minute
Change from Baseline Respiratory Rate after intervention immediately
Time frame: baseline, 15 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with Music and Anxiety, run by National Defense Medical Center, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Anxiety after intervention immediately (time frame: baseline, 15 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.