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Completed
NCT07785297
Maternal Voice Versus White Noise in Pediatric Surgery
Conditions: Children, Postoperative Pain, Physiological Parameters, Comfort
Sex: All
Ages: 1 Year – 3 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Kocaeli University
Location: Kocaeli University Kocaeli İ̇zmi̇t
Summary
This randomized controlled study will evaluate the effects of maternal voice and white noise on postoperative pain, comfort, and physiological parameters in children aged 1 month to 3 years during the early postoperative period. The study will also compare the effectiveness of maternal voice and white noise in improving these outcomes.
Eligibility Criteria
Inclusion Criteria:
* Aged 1 to 3 years
* Scheduled to undergo an elective minor surgical procedure, such as orchiopexy, hypospadias repair, or hernia repair
* Undergoing surgery under general anesthesia with an anesthesia duration not exceeding 60 minutes
* No known hearing impairment
* No anatomical abnormality of the ear
* No chronic condition that could affect auditory perception or pain response, such as cerebral palsy, Down syndrome, or another neurodevelopmental disorder
* Scheduled for direct transfer to the pediatric surgery ward after surgery without an extended stay in the postanesthesia care unit
* Written informed consent provided by a parent or legal guardian
Exclusion Criteria:
* Surgery performed under emergency conditions
* A surgical procedure different from the planned procedure
* Anesthesia duration exceeding 60 minutes
* Development of a postoperative complication requiring admission to the postanesthesia care unit or intensive care unit
* Administration of additional analgesic medication beyond the institutional analgesia protocol
* Interruption or inability to complete the 60-minute auditory intervention or observation period
* Withdrawal of consent by the parent or legal guardian
Source: ClinicalTrials.gov (NCT07785297). StuddyBuddy aggregates publicly available trial information.