Children, Comfort, Physiological Parameters, Postoperative Pain
Conditions
Keywords
Pediatric surgery, Maternal voice, White noise, Pain management, Comfort
Brief 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.
Detailed description
For the maternal voice intervention, the mother will select a lullaby, and its lyrics will be provided to her by the researcher. The lullaby will be recorded in the mother's voice with the assistance of the researcher. The sound level of the recording will be adjusted to approximately 50 decibels. Children assigned to the maternal voice group will listen to the recorded lullaby during the early postoperative period. A copy of the recording will be provided to the mother after completion of the study. Children assigned to the white noise group will listen to the white noise recording "Don't Let Your Baby Cry 2" from the album "Colic." The recording includes intrauterine-like and white-noise sounds combined with music. The recording will be used after obtaining the necessary permissions from the relevant copyright holders.
Interventions
OTHERMaternal Voice Recording
Before surgery, each mother selected and recorded a lullaby in a quiet room with guidance from the researcher. Following postoperative admission to the pediatric surgery ward, the recording was played continuously to the child for 60 minutes through a portable speaker. Sound intensity was monitored using a calibrated sound-level meter and maintained at 50-55 decibels.
OTHERWhite Noise Recording
Children listened to the standardized recording "Don't Let Your Baby Cry 2" from the album "Colic." The recording included intrauterine-like sounds, white-noise frequency components, and accompanying music. It was played continuously for 60 minutes through a portable speaker. Sound intensity was monitored using a calibrated sound-level meter and maintained at 50-55 decibels.
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale | 30 and 60 minutes after admission to the pediatric surgery ward | Postoperative pain was assessed using the Face, Legs, Activity, Cry, and Consolability Scale. The scale evaluates five behavioral domains: facial expression, leg movement, activity, crying, and consolability. Each domain is scored from 0 to 2, producing a total score ranging from 0 to 10. Higher scores indicate greater postoperative pain and therefore a worse outcome. The scale was administered at 30 and 60 minutes. The prespecified primary endpoint was the total score at 60 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score | 30 and 60 minutes after admission to the pediatric surgery ward | Postoperative recovery was assessed using the Modified Aldrete Recovery Score. The scale evaluates five domains: motor activity, respiration, circulation, consciousness, and peripheral oxygen saturation. Each domain is scored from 0 to 2, producing a total score ranging from 0 to 10. Higher scores indicate a better level of postoperative recovery. A score of 9 or higher generally indicates readiness for discharge from postanesthesia care. The scale was administered at 30 and 60 minutes. The prespecified secondary endpoint was the total score at 60 minutes. |
| Heart Rate | Immediately after admission and before the intervention, and at 30 and 60 minutes | Heart rate was measured using a pulse oximeter and recorded as beats per minute. Lower values within the age-appropriate physiological range indicate reduced physiological arousal; however, the measure does not have a predefined better or worse direction independently of the clinical context. |
| Respiratory Rate | Immediately after admission and before the intervention, and at 30 and 60 minutes | Respiratory rate was recorded as breaths per minute. Lower values within the age-appropriate physiological range may indicate reduced physiological arousal; however, the measure does not have a predefined better or worse direction independently of the clinical context. |
| Peripheral Oxygen Saturation | Immediately after admission and before the intervention, and at 30 and 60 minutes | Peripheral oxygen saturation was measured using a pulse oximeter and recorded as a percentage. Higher values within the clinically expected range indicate better oxygenation. |
Countries
Turkey (Türkiye)
Outcome results
None listed