ChildrenNCT07785297
Maternal Voice Versus White Noise in Pediatric Surgery
A study testing Maternal Voice Recording and White Noise Recording in people with Children and Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Children, Postoperative Pain, Physiological Parameters
- What is being tested?
- Maternal Voice Recording and White Noise Recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Voice Versus White Noise: Effects on Pain, Comfort, and Physiological Responses in Pediatric Surgery
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.
Read the 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.
- Conditions
- Children, Postoperative Pain, Physiological Parameters, Comfort
- Being tested
- Maternal Voice Recording, White Noise Recording
- Keywords
- Pediatric surgery, Maternal voice, White noise, Pain management, Comfort
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Voice RecordingOther
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.
White Noise RecordingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Maternal voice | Experimental | Children received routine postoperative nursing care and listened continuously for 60 minutes to a preoperatively recorded lullaby sung by their mother. Playback began after baseline physiological measurements following admission to the pediatric surgery ward. The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels. Receives: Other: Maternal Voice Recording |
| White noise | Experimental | Children received routine postoperative nursing care and listened continuously to a standardized white noise recording for 60 minutes. Playback began after baseline physiological measurements following admission to the pediatric surgery ward. The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels. Receives: Other: White Noise Recording |
| Control Arm | No intervention | Children received routine postoperative nursing care without a structured auditory intervention. No planned silence or sound restriction was imposed, and the children remained in the usual auditory environment of the pediatric surgery ward. Outcome assessments were conducted at the same time points as in the intervention groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale
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.
Measured: 30 and 60 minutes after admission to the pediatric surgery ward
Secondary outcomes (4)
Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score
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.
Measured: 30 and 60 minutes after admission to the pediatric surgery ward
Heart Rate
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.
Measured: Immediately after admission and before the intervention, and at 30 and 60 minutes
Respiratory Rate
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.
Measured: Immediately after admission and before the intervention, and at 30 and 60 minutes
Peripheral Oxygen Saturation
Peripheral oxygen saturation was measured using a pulse oximeter and recorded as a percentage. Higher values within the clinically expected range indicate better oxygenation.
Measured: Immediately after admission and before the intervention, and at 30 and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Öztürkler, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785297
- Sponsor's protocol ID
- 2023/361
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Voice Versus White Noise: Effects on Pain, Comfort, and Physiological Responses in Pediatric Surgery
- ClinicalTrials.gov ID
- NCT07785297
- Acronym / sponsor ID
- 2023/361
- Conditions
- Children, Postoperative Pain, Physiological Parameters, Comfort
- Keywords
- Pediatric surgery, Maternal voice, White noise, Pain management, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maternal voice | Experimental | Other: Maternal Voice RecordingChildren received routine postoperative nursing care and listened continuously for 60 minutes to a preoperatively recorded lullaby sung by their mother. Playback began after baseline physiological measurements following admission to the pediatric surgery ward. The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels. |
| White noise | Experimental | Other: White Noise RecordingChildren received routine postoperative nursing care and listened continuously to a standardized white noise recording for 60 minutes. Playback began after baseline physiological measurements following admission to the pediatric surgery ward. The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels. |
| Control Arm | No intervention | –Children received routine postoperative nursing care without a structured auditory intervention. No planned silence or sound restriction was imposed, and the children remained in the usual auditory environment of the pediatric surgery ward. Outcome assessments were conducted at the same time points as in the intervention groups. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal Voice RecordingBefore 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. | Other | Maternal voice |
| White Noise RecordingChildren 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. | Other | White noise |
Primary outcome
Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale
Time frame: 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.
4 secondary outcomes
Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score
Time frame: 30 and 60 minutes after admission to the pediatric surgery ward
Heart Rate
Time frame: Immediately after admission and before the intervention, and at 30 and 60 minutes
Respiratory Rate
Time frame: Immediately after admission and before the intervention, and at 30 and 60 minutes
Peripheral Oxygen Saturation
Time frame: Immediately after admission and before the intervention, and at 30 and 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Voice Recording and White Noise Recording in people with Children and Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale (time frame: 30 and 60 minutes after admission to the pediatric surgery ward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.