Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TC Erciyes University
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- amount of propofol dose used in sedation
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- 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.
Arms & Interventions
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.
Intervention: Group headphone (Procedure)
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.
Intervention: Group music (Procedure)
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.
Intervention: Group maternal voice (Procedure)
Outcomes
Primary Outcomes
amount of propofol dose used in sedation
Time Frame: during the MRI procedure
The total propofol dosage were recorded in during procedure.
Secondary Outcomes
No secondary outcomes reported
Investigators
Özlem ÖZ GERGİN
Principal Investigator
TC Erciyes University