NCT04112979View on ClinicalTrials.gov

Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW)

NACompletedINTERVENTIONAL

Enrollment

115

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

August 23, 2019

Study Completion Date

August 24, 2019

Conditions

Procedural AnxietyProcedural PainAdenotonsillitis

Interventions

BEHAVIORAL

Music

45 dB SL, normalized, high-frequency sampled W.A. Mozart Symphony n°4 in D K19 and n°5 in B-flat K22 (from Mozart Symphonies Vol. I - Adam Fisher, Dacapo Records, Frederiksberg C., Denmark, 2013)

BEHAVIORAL

Mother's lap

45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped

BEHAVIORAL

Soundproof earplugs

Disposable foam earplugs with a noise attenuation of at least 30 dB

Trial Locations (1)

34137

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-, Trieste

All Listed Sponsors

lead

IRCCS Burlo Garofolo

OTHER

NCT04112979 - Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW) | Biotech Hunter | Biotech Hunter