ColonoscopyColoRelaxToneNCT04258800
Impact of Music in Colonoscopy
A study testing Music during colonoscopy in people with Colonoscopy and Music, run by University of Ulm at 1 site in Germany.
Trial summary
The study examines the impact of music during colonoscopy on sympathetic - autonomic nervous system, whose activity is operationalized by biopotentials signals. The music is chosen by the patients themselves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Music, Pain
- What is being tested?
- Music during colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 12 Nov 2019to 26 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for colonoscopy
- conscious sedation with propofol
- ASA state 1 or 2
Who cannot join
- lack of written informed consent
- pregnancy
- General anaesthetics
- ASA state >2
- deafness, Hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Music During Colonoscopy on Sympathetic - Autonomic Nervous System
The study examines the impact of music during colonoscopy on sympathetic - autonomic nervous system, whose activity is operationalized by biopotentials signals. The music is chosen by the patients themselves.
The Null hypothesis: The comparison of the sympathetic - autonomic nervous system (operationalized by biopotentials) intensity between colonoscopy "with" vs. "without" music is not significant.
Alternative hypothesis: The comparison of the sympathetic - autonomic nervous system intensity is significantly higher in colonoscopy "without" music vs. "with" music.
Read the detailed description
In the field of endoscopy, stress and pain play a relevant role before and during the examination. A variety of methods have been evaluated to date to provide the patient with relaxation/distraction during the examination. Especially the use of relaxation music. However, the previous studies refer to a subjective assessment of the participants after the examination. Here at least one potential bias is to be assumed from the post-procedural euphoria through the use of propofol and/or midazolam. Pain reactions express themselves explicitly in autonomous function. In contrast to our previous work, the present study uses biopotential signals for the objective operationalization of stress reduction.
The activity of the sympathetic - autonomic nervous system is operationalized by biopotentials fixed to the body surface:
- in the face area (corrugator, zygomaticus)
- on the hand (skin conductance, temperature)
- on the torso (electrocardiogram) The satisfaction of the patient and endoscopist with endoscopical procedure were asked using questionnaires.
- Conditions
- Colonoscopy, Music, Pain
- Being tested
- Music during colonoscopy
- Keywords
- colonoscopy, music, relaxation, satisfaction
- Medical subject headings
- Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music during colonoscopyDevice
Music during colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| With music | Experimental | Colonoscopy performed with music Receives: Device: Music during colonoscopy |
| Without music | No intervention | Colonoscopy performed without music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Music on EMG (M. Zygomaticus, M. Corrugator)
Evaluation of biopotential signals for the objective operationalization of stress reduction
Measured: During colonoscopy procedure
Impact of Music on EKG (heart rate, heart rate variability)
Evaluation of biopotential signals for the objective operationalization of stress reduction
Measured: During colonoscopy procedure
Impact of Music on skin conductance in micro Siemens
Evaluation of biopotential signals for the objective operationalization of stress reduction
Measured: During colonoscopy procedure
Impact of Music on skin temperature in degrees Celsius
Evaluation of biopotential signals for the objective operationalization of stress reduction
Measured: During colonoscopy procedure
Impact of Music on Propofol Dosis in millilitres
Evaluation of sedation requirements for the objective operationalization of stress reduction
Measured: During colonoscopy procedure
Impact of Music on procedure time in minutes
Evaluation of examination time for the objective operationalization of stress reduction
Measured: During colonoscopy procedure
Patient satisfaction with endoscopical procedure by means of questionnaire
Satisfaction of the patient with endoscopical procedure rated on a scale from 1 to 4 (1 means best rating, 7 means worst rating)
Measured: Approximately 45 minutes after colonoscopy was finished
Patient satisfaction with sedation by means of questionnaire
Satisfaction of the patient with sedation rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Measured: Approximately 45 minutes after colonoscopy was finished
Endoscopist satisfaction by means of questionnaire
Satisfaction of the endoscopist with endoscopical procedure rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Measured: immediately after colonoscopy was finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start12 Nov 2019
- Primary completion15 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Ulm
- Responsible party
- Principal investigator, Thomas Seufferlein, University of Ulm
- Investigators
- Benjamin Walter, MD, Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258800
- Sponsor's protocol ID
- MUSIC123
- Acronym
- ColoRelaxTone
- Status last verified
- Mar 2020
- First submitted
- 17 Dec 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Music During Colonoscopy on Sympathetic - Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT04258800
- Acronym / sponsor ID
- ColoRelaxTone / MUSIC123
- Conditions
- Colonoscopy, Music, Pain
- Keywords
- colonoscopy, music, relaxation, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- University Hospital Ulm
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 6 Feb 2020 (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.
The study examines the impact of music during colonoscopy on sympathetic - autonomic nervous system, whose activity is operationalized by biopotentials signals. The music is chosen by the patients themselves.
The Null hypothesis: The comparison of the sympathetic - autonomic nervous system (operationalized by biopotentials) intensity between colonoscopy "with" vs. "without" music is not significant.
Alternative hypothesis: The comparison of the sympathetic - autonomic nervous system intensity is significantly higher in colonoscopy "without" music vs. "with" music.
Detailed description
In the field of endoscopy, stress and pain play a relevant role before and during the examination. A variety of methods have been evaluated to date to provide the patient with relaxation/distraction during the examination. Especially the use of relaxation music. However, the previous studies refer to a subjective assessment of the participants after the examination. Here at least one potential bias is to be assumed from the post-procedural euphoria through the use of propofol and/or midazolam. Pain reactions express themselves explicitly in autonomous function. In contrast to our previous work, the present study uses biopotential signals for the objective operationalization of stress reduction.
The activity of the sympathetic - autonomic nervous system is operationalized by biopotentials fixed to the body surface:
- in the face area (corrugator, zygomaticus)
- on the hand (skin conductance, temperature)
- on the torso (electrocardiogram) The satisfaction of the patient and endoscopist with endoscopical procedure were asked using questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With music | Experimental | Device: Music during colonoscopyColonoscopy performed with music |
| Without music | No intervention | –Colonoscopy performed without music |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for colonoscopy
- conscious sedation with propofol
- ASA state 1 or 2
Key exclusion criteria (5 listed)
- lack of written informed consent
- pregnancy
- General anaesthetics
- ASA state >2
- deafness, Hearing 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 during colonoscopyMusic during colonoscopy | Device | With music |
Primary outcome
Impact of Music on EMG (M. Zygomaticus, M. Corrugator)
Time frame: During colonoscopy procedure
Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on EKG (heart rate, heart rate variability)
Time frame: During colonoscopy procedure
Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on skin conductance in micro Siemens
Time frame: During colonoscopy procedure
Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on skin temperature in degrees Celsius
Time frame: During colonoscopy procedure
Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on Propofol Dosis in millilitres
Time frame: During colonoscopy procedure
Evaluation of sedation requirements for the objective operationalization of stress reduction
Impact of Music on procedure time in minutes
Time frame: During colonoscopy procedure
Evaluation of examination time for the objective operationalization of stress reduction
Patient satisfaction with endoscopical procedure by means of questionnaire
Time frame: Approximately 45 minutes after colonoscopy was finished
Satisfaction of the patient with endoscopical procedure rated on a scale from 1 to 4 (1 means best rating, 7 means worst rating)
Patient satisfaction with sedation by means of questionnaire
Time frame: Approximately 45 minutes after colonoscopy was finished
Satisfaction of the patient with sedation rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Endoscopist satisfaction by means of questionnaire
Time frame: immediately after colonoscopy was finished
Satisfaction of the endoscopist with endoscopical procedure rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
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 27 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Benjamin Walter, MD principal investigator
University Hospital Ulm
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 during colonoscopy in people with Colonoscopy and Music, run by University of Ulm at 1 site in Germany.
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 5 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 27 Mar 2020. 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 Germany. 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?
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?
Impact of Music on EMG (M. Zygomaticus, M. Corrugator) (time frame: During colonoscopy procedure). The study lists 9 primary outcomes in all. 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 27 Mar 2020.