Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging.

Sponsor

TC Erciyes University (Other)

Overall Status

Completed

CT.gov ID

NCT04944875

Collaborator

(none)

210

Enrollment

Location

Arms

Actual Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric Solid Tumor Pediatric Brain Tumor Pediatric Cancer	Procedure: Group headphone Procedure: Group music Procedure: Group maternal voice	N/A

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

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

May 1, 2021

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I; group headphone 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 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.
Active Comparator: Group II; group music 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 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.
Active Comparator: Group III; group maternal voice 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 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.

Arm

Intervention/Treatment

Active Comparator: Group I; group headphone

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

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.

Active Comparator: Group II; group music

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

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.

Active Comparator: Group III; group maternal voice

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

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.

Outcome Measures

Primary Outcome Measures

amount of propofol dose used in sedation [during the MRI procedure]
The total propofol dosage were recorded in during procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

ASA (American Society of Anesthesiologists) I-II

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Özlem Öz Gergin	Kayseri		Turkey	38090

Sponsors and Collaborators

TC Erciyes University

Investigators

Principal Investigator: Ozlem Oz Gergin, TC Erciyes University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Özlem ÖZ GERGİN, Principal Investigator, TC Erciyes University

ClinicalTrials.gov Identifier:

NCT04944875

Other Study ID Numbers:

2019/266

First Posted:

Jun 30, 2021

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Özlem ÖZ GERGİN, Principal Investigator, TC Erciyes University

Study Results

No Results Posted as of Jun 30, 2021