Gastrointestinal Endoscopic ProceduresNCT04096508
Role of Music Listening in Gastrointestinal Endoscopy
A study testing Music listening in people with Gastrointestinal Endoscopic Procedures, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
Gastrointestinal endoscopy is widely acknowledged as the most useful tool for diagnosing and treating gastrointestinal mucosal lesions. It can not only observe the mucosa directly, but also obtain tissue biopsy for pathological diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Endoscopic Procedures
- 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
- 1 siteChina
- Study dates
- 1 Oct 2019to 31 Jan 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years old patients
- Who agree to participate in the study
- Patients with the indications for gastrointestinal endoscopy
Who cannot join
- Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
- Severe uncontrolled coagulopathy
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
About this study
Official title: Application of Music Listening in Gastrointestinal Endoscopic Procedures
Gastrointestinal endoscopy is widely acknowledged as the most useful tool for diagnosing and treating gastrointestinal mucosal lesions. It can not only observe the mucosa directly, but also obtain tissue biopsy for pathological diagnosis. Although the importance of gastrointestinal endoscopy has been well understood, there are still a certain proportion of people who are unwilling to undergo it due to the discomfort and anxiety during the procedures. Music is multifunctional, which can alleviate people's depression, anxiety and other negative emotions as well as help to maintain good mental health. Thus, in this study we aim to investigate the role of music listening in gastrointestinal endoscopy in a randomized controlled clinical trial, especially for those patients who plan to undergo therapeutic endoscopic procedures and try to improve the patients' experience.
Read the detailed description
This is a randomized controlled trial to examine the function of music listening in the procedures of gastrointestinal endoscopy. It was previously reported that music listening may exert beneficial effects for patients who undergo gastrointestinal endoscopy. However, most of the studies did not analyze the effects of the specific music type and listening time in diagnostic and therapeutic gastrointestinal endoscopic procedures, respectively. This study will test whether the specific music type and listening time before gastrointestinal endoscopy could improve patients' experience of the procedure in a randomized controlled trial. The results may help to optimize the routine clinical practice at present.
- Conditions
- Gastrointestinal Endoscopic Procedures
- Being tested
- Music listening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningBehavioural
Patients sit comfortably in a chair for 20 min listening music before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients sit comfortably in a chair for 20 min listening classic music before the procedure. Receives: Behavioral: Music listening |
| Group B | Experimental | Patients sit comfortably in a chair for 20 min listening popular music before the procedure. Receives: Behavioral: Music listening |
| Control group | No intervention | Patients sit comfortably in a chair for 20 min without music listening before the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
A 10-point scale was used to evaluate the patients' pain (0 least, 10 most). All the discomforts such as abdominal pain, distension and the like were all recorded.
Measured: 4 months
Secondary outcomes (1)
Patients' satisfaction and willingness to undergo gastrointestinal endoscopy again
A 10-point scale was used to evaluate the patients' satisfaction (0 worst, 10 best).
It is anticipated that the use of music listening will significantly improve patients' satisfaction.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Endoscopic ProceduresStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096508
- Sponsor's protocol ID
- 307-GIE-m
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee D, Henderson A, Shum D. The effect of music on preprocedure anxiety in Hong Kong Chinese day patients. J Clin Nurs. 2004 Mar;13(3):297-303. doi: 10.1046/j.1365-2702.2003.00888.x.
PubMed 15009332Hayes A, Buffum M, Lanier E, Rodahl E, Sasso C. A music intervention to reduce anxiety prior to gastrointestinal procedures. Gastroenterol Nurs. 2003 Jul-Aug;26(4):145-9. doi: 10.1097/00001610-200307000-00002.
PubMed 12920428Bechtold ML, Puli SR, Othman MO, Bartalos CR, Marshall JB, Roy PK. Effect of music on patients undergoing colonoscopy: a meta-analysis of randomized controlled trials. Dig Dis Sci. 2009 Jan;54(1):19-24. doi: 10.1007/s10620-008-0312-0. Epub 2008 May 16.
PubMed 18483858
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Music Listening in Gastrointestinal Endoscopic Procedures
- ClinicalTrials.gov ID
- NCT04096508
- Acronym / sponsor ID
- 307-GIE-m
- Conditions
- Gastrointestinal Endoscopic Procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 20 Sep 2019 (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.
Gastrointestinal endoscopy is widely acknowledged as the most useful tool for diagnosing and treating gastrointestinal mucosal lesions. It can not only observe the mucosa directly, but also obtain tissue biopsy for pathological diagnosis. Although the importance of gastrointestinal endoscopy has been well understood, there are still a certain proportion of people who are unwilling to undergo it due to the discomfort and anxiety during the procedures. Music is multifunctional, which can alleviate people's depression, anxiety and other negative emotions as well as help to maintain good mental health. Thus, in this study we aim to investigate the role of music listening in gastrointestinal endoscopy in a randomized controlled clinical trial, especially for those patients who plan to undergo therapeutic endoscopic procedures and try to improve the patients' experience.
Detailed description
This is a randomized controlled trial to examine the function of music listening in the procedures of gastrointestinal endoscopy. It was previously reported that music listening may exert beneficial effects for patients who undergo gastrointestinal endoscopy. However, most of the studies did not analyze the effects of the specific music type and listening time in diagnostic and therapeutic gastrointestinal endoscopic procedures, respectively. This study will test whether the specific music type and listening time before gastrointestinal endoscopy could improve patients' experience of the procedure in a randomized controlled trial. The results may help to optimize the routine clinical practice at present.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Music listeningPatients sit comfortably in a chair for 20 min listening classic music before the procedure. |
| Group B | Experimental | Behavioral: Music listeningPatients sit comfortably in a chair for 20 min listening popular music before the procedure. |
| Control group | No intervention | –Patients sit comfortably in a chair for 20 min without music listening before the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 18 years old patients
- Who agree to participate in the study
- Patients with the indications for gastrointestinal endoscopy
Key exclusion criteria (3 listed)
- Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
- Severe uncontrolled coagulopathy
- Pregnancy and lactation
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 listeningPatients sit comfortably in a chair for 20 min listening music before the procedure. | Behavioural | Group A, Group B |
Primary outcome
Pain score
Time frame: 4 months
A 10-point scale was used to evaluate the patients' pain (0 least, 10 most). All the discomforts such as abdominal pain, distension and the like were all recorded.
1 secondary outcome
Patients' satisfaction and willingness to undergo gastrointestinal endoscopy again
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Background: PubMed 15009332Lee D, Henderson A, Shum D. The effect of music on preprocedure anxiety in Hong Kong Chinese day patients. J Clin Nurs. 2004 Mar;13(3):297-303. doi: 10.1046/j.1365-2702.2003.00888.x.
- Background: PubMed 12920428Hayes A, Buffum M, Lanier E, Rodahl E, Sasso C. A music intervention to reduce anxiety prior to gastrointestinal procedures. Gastroenterol Nurs. 2003 Jul-Aug;26(4):145-9. doi: 10.1097/00001610-200307000-00002.
- Background: PubMed 18483858Bechtold ML, Puli SR, Othman MO, Bartalos CR, Marshall JB, Roy PK. Effect of music on patients undergoing colonoscopy: a meta-analysis of randomized controlled trials. Dig Dis Sci. 2009 Jan;54(1):19-24. doi: 10.1007/s10620-008-0312-0. Epub 2008 May 16.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with Gastrointestinal Endoscopic Procedures, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaotian Sun, M.D. (86-010-66823480, xiaotian-sun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04096508, which also lists 3 linked publications.
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 20 Sep 2019.