Pediatric Solid TumorNCT04944875
Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging.
A study testing Group headphone, Group music and Group maternal voice in people with Pediatric Solid Tumor and Pediatric Brain Tumor, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Solid Tumor, Pediatric Brain Tumor, Pediatric Cancer
- What is being tested?
- Group headphone, Group music and Group maternal voice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 May 2021
- 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA (American Society of Anesthesiologists) I-II
Who cannot join
- Patients with hearing impairment, distorted ear anatomy, recent organ or system deficiency, severe pulmonary and/or cardiovascular problems, intolerance to propofol, airway ab-normalities, or known psychiatric or mental problems were ex-cluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric
To evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging.
Read the detailed description
When the patients and their parents arrived in the magnetic resonance unıt about 30 minutes before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment.
Patients were categorized into 3 groups: music, maternal voice and isolation. During the procedures,the patients in the music group listened to Vivaldi's The Four Seasons violin concertos by sound isolating headphones, whereas the patients in the isolation group wore the headphones but did not listen to music.
All patients were sedated by midazolam and propofol. During the procedure, an additional propofol was administered as required
- Being tested
- Group headphone, Group music, Group maternal voice
- Keywords
- Magnetic Resonance, sedation, maternal voice, sedative effects
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group headphoneProcedure or surgery
The patients in the first group wore the headphones but did not listen the music or maternal voice. The standard sedation method was applied to all patients.
Group musicProcedure or surgery
The patients in the second group listened to classical music (Vivaldi's The Four Seasons violin concertos) by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.
Group maternal voiceProcedure or surgery
The patients in the third group listened to maternal voice by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.
| Study group | Role | What they receive |
|---|---|---|
| Group I; group headphone | Active comparator | In the first group of the patients in the isolation group wear the headphones but do not listen to music during the procedure. Then patients were sedated by midazolam and propofol. Receives: Procedure: Group headphone |
| Group II; group music | Active comparator | In the second group of the patients wear the headphones and listen to Vivaldi's The Four Seasons violin concertos by sound isolating headphones during the procedure.
Then patients were sedated by midazolam and propofol. Receives: Procedure: Group music |
| Group III; group maternal voice | Active comparator | In the third group of the patients wear the headphones and listen the maternal voice during the procedure.Then patients were sedated by midazolam and propofol. Receives: Procedure: Group maternal voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of propofol dose used in sedation
The total propofol dosage were recorded in during procedure.
Measured: during the MRI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 May 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric Solid TumorStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem ÖZ GERGİN, TC Erciyes University
- Investigators
- Ozlem Oz Gergin, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944875
- Sponsor's protocol ID
- 2019/266
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Starkey E, Sammons HM. Sedation for radiological imaging. Arch Dis Child Educ Pract Ed. 2011 Jun;96(3):101-6. doi: 10.1136/adc.2008.153072. Epub 2010 Jul 30. No abstract available.
PubMed 20675522Ahmad R, Hu HH, Krishnamurthy R, Krishnamurthy R. Reducing sedation for pediatric body MRI using accelerated and abbreviated imaging protocols. Pediatr Radiol. 2018 Jan;48(1):37-49. doi: 10.1007/s00247-017-3987-6. Epub 2018 Jan 1.
PubMed 29292482
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric
- ClinicalTrials.gov ID
- NCT04944875
- Acronym / sponsor ID
- 2019/266
- Keywords
- Magnetic Resonance, sedation, maternal voice, sedative effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 30 Jun 2021 (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.
To evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging.
Detailed description
When the patients and their parents arrived in the magnetic resonance unıt about 30 minutes before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment.
Patients were categorized into 3 groups: music, maternal voice and isolation. During the procedures,the patients in the music group listened to Vivaldi's The Four Seasons violin concertos by sound isolating headphones, whereas the patients in the isolation group wore the headphones but did not listen to music.
All patients were sedated by midazolam and propofol. During the procedure, an additional propofol was administered as required
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I; group headphone | Active comparator | Procedure: Group headphoneIn the first group of the patients in the isolation group wear the headphones but do not listen to music during the procedure. Then patients were sedated by midazolam and propofol. |
| Group II; group music | Active comparator | Procedure: Group musicIn the second group of the patients wear the headphones and listen to Vivaldi's The Four Seasons violin concertos by sound isolating headphones during the procedure. Then patients were sedated by midazolam and propofol. |
| Group III; group maternal voice | Active comparator | Procedure: Group maternal voiceIn the third group of the patients wear the headphones and listen the maternal voice during the procedure.Then patients were sedated by midazolam and propofol. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA (American Society of Anesthesiologists) I-II
Key exclusion criteria (1 listed)
- Patients with hearing impairment, distorted ear anatomy, recent organ or system deficiency, severe pulmonary and/or cardiovascular problems, intolerance to propofol, airway ab-normalities, or known psychiatric or mental problems were ex-cluded from the study.
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 |
|---|---|---|
| Group headphoneThe patients in the first group wore the headphones but did not listen the music or maternal voice. The standard sedation method was applied to all patients. | Procedure or surgery | Group I; group headphone |
| Group musicThe patients in the second group listened to classical music (Vivaldi's The Four Seasons violin concertos) by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients. | Procedure or surgery | Group II; group music |
| Group maternal voiceThe patients in the third group listened to maternal voice by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients. | Procedure or surgery | Group III; group maternal voice |
Primary outcome
amount of propofol dose used in sedation
Time frame: during the MRI procedure
The total propofol dosage were recorded in during procedure.
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 30 Jun 2021.
- Background: PubMed 20675522Starkey E, Sammons HM. Sedation for radiological imaging. Arch Dis Child Educ Pract Ed. 2011 Jun;96(3):101-6. doi: 10.1136/adc.2008.153072. Epub 2010 Jul 30. No abstract available.
- Background: PubMed 29292482Ahmad R, Hu HH, Krishnamurthy R, Krishnamurthy R. Reducing sedation for pediatric body MRI using accelerated and abbreviated imaging protocols. Pediatr Radiol. 2018 Jan;48(1):37-49. doi: 10.1007/s00247-017-3987-6. Epub 2018 Jan 1.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Ozlem Oz Gergin principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group headphone, Group music and Group maternal voice in people with Pediatric Solid Tumor and Pediatric Brain Tumor, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 30 Jun 2021. 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 Turkey (Türkiye). 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?
amount of propofol dose used in sedation (time frame: during the MRI procedure). 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 NCT04944875, which also lists 2 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 30 Jun 2021.