PainNCT07753486
Effect of Maternal Voice on Pain, Sedation, and Physiological Parameters in Mechanically Ventilated Children
A study testing Recorded Maternal Voice in people with Pain and Sedation, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Children in the pediatric intensive care unit often experience pain and stress from medical procedures, even while sedated. This study will test whether playing a recording of the child's mother's voice helps reduce pain and the need for sedation medication in children aged 1 to 3 years who are on a breathing machine… Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Pain, Sedation, Mechanical Ventilation
- What is being tested?
- Recorded Maternal Voice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 15 Dec 2026
- Phase
- Interventional
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
- Children aged 1-3 years, intubated and mechanically ventilated under sedation
- No change in sedation dose within the last 24 hours
- No hearing impairment in the child
- Parent has no visual, hearing, or speech impairment
- Parent is a Turkish speaker/reader with at least a primary school education
- Parent provides written and verbal informed consent
Who cannot join
- Children receiving care/treatment due to surgical operation or trauma
- Children who experience cardiac arrest during the study
- Children whose parent withdraws consent during the study
- Children who are extubated during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kayseri City Hospital
Kayseri, Kayseri
GAMZE NUR GÜZEL, RN, +905535664246, gmznrgzl446@gmail.com
MERAL BAYAT, PhD, +905336504292, mbayat@erciyes.edu.tr
About this study
Official title: The Effect of Maternal Voice Played to Children on Mechanical Ventilators on Pain, Sedation, and Physiological Parameters: A Randomized Controlled Trial
Children in the pediatric intensive care unit often experience pain and stress from medical procedures, even while sedated. This study will test whether playing a recording of the child's mother's voice helps reduce pain and the need for sedation medication in children aged 1 to 3 years who are on a breathing machine (mechanical ventilator). Children will be randomly placed into one of two groups: one group will listen to a 10-minute recording of their mother's voice through headphones, while the other group will receive usual care with no recording. Researchers will measure pain and comfort levels, heart rate, oxygen levels, blood pressure, and breathing rate before, during, and after the session to see if listening to the mother's voice makes a difference.
Read the detailed description
This randomized controlled trial will be conducted in the Pediatric Intensive Care Unit (PICU) of Kayseri City Hospital. Eligible children (aged 1-3 years, intubated, mechanically ventilated, and sedated, with no change in sedation dose in the prior 24 hours) will be assigned to an intervention or control group using stratified block randomization (stratified by age, sex, diagnosis duration, and COMFORT scale score), with simple randomization within blocks performed by an independent researcher.
In the intervention group, each child's mother will be asked to read a children's storybook aloud in a quiet room, and this reading will be recorded (approximately 10 minutes). The recording will then be played to the child once, through wireless over-ear headphones at a safe volume (50-55 dB), during a single morning session. The COMFORT Scale and physiological parameters (heart rate, oxygen saturation, blood pressure, respiratory rate) will be assessed before, during, and after the recording is played. All sessions will be video recorded so that COMFORT Scale scores can also be scored by independent, blinded observers.
Children in the control group will receive standard unit care with no additional intervention, and will be assessed on the same schedule and with the same tools as the intervention group.
Data will be analyzed using IBM SPSS 27.0. Group comparisons will use Chi-square, Independent/Paired Samples t-tests, or Mann-Whitney U/Wilcoxon tests as appropriate, with statistical significance set at p < 0.05.
- Conditions
- Pain, Sedation, Mechanical Ventilation
- Being tested
- Recorded Maternal Voice
- Keywords
- Maternal Voice, Pediatric Intensive Care Unite, Physiological Parameters, COMFORT Scale, Non-pharmacological Intervention
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recorded Maternal VoiceBehavioural
A single ~10-minute audio recording of the child's own mother reading a children's storybook ("The Invisible String," Turkish edition) will be played once through wireless over-ear headphones at a safe listening level (50-55 dB), during a single morning session (10:00-12:00), with no other procedural interventions during playback. The recording will be made in a quiet room by an independent researcher using a digital audio recorder.
Want to be notified when Claude responds?
| Study group | Role | What they receive |
|---|---|---|
| Maternal Voice Intervention Group | Experimental | Children received a single ~10-minute recording of their mother's voice reading a children's storybook, played once through wireless over-ear headphones at 50-55 dB during a single morning session, with no other interventions during playback. Receives: Behavioral: Recorded Maternal Voice |
| Control Group | No intervention | Children received standard PICU care with no additional intervention. Assessments (COMFORT Scale, physiological parameters, video recording) were performed on the same schedule as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMFORT Scale
The COMFORT Scale (full behavioral and physiological scale for assessing pain and sedation level in critically ill children) assesses eight items - alertness, calmness, respiratory response, physical movement, blood pressure, heart rate, muscle tone, and facial tension - each scored 1 to 5, yielding a total score ranging from 8 (minimum) to 40 (maximum). Higher scores indicate greater distress/pain and inadequate sedation, while lower scores indicate deeper sedation and better comfort. Scores will be compared between the maternal voice intervention group and the control group.
Measured: Assessed before (~5 min), during (~10 min), and immediately after (~5 min) the intervention, within a single ~20-minute session on the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized into two parallel groups: an intervention group receiving recorded maternal voice and a control group receiving standard unit care, assessed concurrently.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Nur Güzel, TC Erciyes University
- Investigators
- MERAL BAYAT, PhD, Study chair, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753486
- Sponsor's protocol ID
- 2025/607
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as this is a single-center thesis study involving a vulnerable pediatric population, and no data sharing infrastructure or consent for external data sharing was established as part of the study protocol.