NCT04944875

Brief Summary

To evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 22, 2021

Last Update Submit

June 22, 2021

Conditions

Pediatric Solid TumorPediatric Brain TumorPediatric Cancer

Keywords

Magnetic Resonancesedationmaternal voicesedative effects

Outcome Measures

Primary Outcomes (1)

  • amount of propofol dose used in sedation

    The total propofol dosage were recorded in during procedure.

    during the MRI procedure

Study Arms (3)

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.

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.

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.

Procedure: Group maternal voice

Interventions

Group headphonePROCEDURE

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 I; group headphone
Group musicPROCEDURE

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 II; group music
Group maternal voicePROCEDURE

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.

Group III; group maternal voice

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA (American Society of Anesthesiologists) I-II

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özlem Öz Gergin

Kayseri, 38090, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 20675522BACKGROUND

  • Ahmad 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.

    PMID: 29292482BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ozlem Oz Gergin

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 30, 2021

Study Start

May 1, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 24 months of study completion
Access Criteria
Data accept requests will be reviewed by an external independent Review Panel.

Locations

TU(1)