İnfant StressNCT07673133
EFFECT OF VOCAL SOOTHING ON STRESS IN NEONATES DURING NURSING CARE
A study testing vocal soothing in people with İnfant Stress, run by Aydin Adnan Menderes University.
Trial summary
The aim of this study is to determine the effect of verbal soothing applied by the researcher during routine nursing care in the neonatal intensive care unit on neonatal stress and physiological parameters. Newborns will be divided into two groups, an intervention group and a control group, using simple randomization. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- İnfant Stress
- What is being tested?
- vocal soothing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with a gestational age between 32 0/7 and 36 6/7 weeks
- Newborns with an APGAR score above 6 at 5 minutes
- Newborns weighing over 1000 grams
- Newborns not on mechanical ventilation
- Newborns who have been fed at least one hour prior to care
- Newborns cared for in an incubator
- Newborns who have passed the hearing test
Who cannot join
- Presence of a condition that prevents the assessment of stress and physiological parameters (birth trauma, intracranial hemorrhage, congenital anomaly, etc.),
- Undergoing an invasive procedure that causes different stress at least one hour before the care (intravenous access, aspiration procedure, etc.),
- Administration of sedatives, opioids, and anticonvulsant drugs before the care.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: THE EFFECT OF VOCAL SOOTHING DURING NURSING CARE ON INFANT STRESS AND PHYSIOLOGICAL PARAMETERS IN THE NEONATAL INTENSIVE CARE UNIT
The aim of this study is to determine the effect of verbal soothing applied by the researcher during routine nursing care in the neonatal intensive care unit on neonatal stress and physiological parameters.
Newborns will be divided into two groups, an intervention group and a control group, using simple randomization. Verbal soothing will be applied to the intervention group during routine nursing care (eye care, oral care, diaper changing, probe placement, weight measurement, body care), while no intervention will be performed on the infants in the control group; only routine care procedures will be applied.
- Conditions
- İnfant Stress
- Being tested
- vocal soothing
- Keywords
- newborn, stress, care, nurse, soothing voice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vocal soothingBehavioural
Prior to the afternoon routine care in the Neonatal Intensive Care Unit, baseline assessments will be completed by the selected clinical nurse using the Neonatal Stress Scale and Neonatal Follow-up Form. During the approximately 10-minute routine care procedure (eye care, oral care, diaper change, probe repositioning, and weight measurement), the investigator will administer a verbal reassurance intervention. The intervention involves speaking to the newborn calmly, reassuringly, and lovingly from a distance of approximately 20 cm, maintaining eye contact and minimizing environmental stimuli. The volume will be kept between 45-60 dB. Outcome measurements will be repeated by the same nurse 5 minutes after the start of care and 5 minutes after the completion of care.
| Study group | Role | What they receive |
|---|---|---|
| Vocal Shooting Group | Experimental | Newborns in this group receive researcher-delivered vocal shooting during nursing care procedures in the NICU. Receives: Behavioral: vocal soothing |
| Control Group | No intervention | Newborns in this group will not undergo any intervention by the researcher; routine care procedures will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Stress Assessment Scale
The Neonatal Stress Assessment Scale (NISS) was developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants. The scale consists of 24 items on a 3-point Likert scale, comprising 8 subgroups including facial expression, body color, breathing, activity level, soothing ability, muscle tone, extremities, and posture. Each subgroup is scored from 0 to 2 points. The minimum score is 0, and the maximum is 16. A high score indicates increased stress. The scale is evaluated through observation. It is sufficient for the infant to exhibit only one behavior from each cell in their free-standing space. A high value is valid if the infant exhibits behaviors from two different cell types (for example, if the infant shows signs corresponding to both 1 and 2 points). A stable and regular state indicates a high value of 0.
Measured: The Neonatal Stress Scale will be completed by a pre-assigned nurse approximately 1 minute before care begins, 5 minutes after care starts, and 1 minute after care ends. The same nurse will then complete the stress scale and the newborn follow-up form.
Secondary outcomes (1)
PHYSIOLOGICAL PARAMETERS
The newborn care duration, oxygen saturation, and pulse of newborns in the intervention and control groups will be recorded using the newborn follow-up form.
Measured: Routine nursing care will last approximately 10 minutes. The information sheet will be filled out by a nurse selected from the clinic 1 minute before, in the middle of, and 5 minutes after the routine nursing care for newborns.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study startFeb 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for İnfant StressStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Verbal soothing intervention in the neonatal intensive care unit is based on the principle of a nurse speaking to the baby from a distance of approximately 20 cm, without a mask, using a calm and compassionate tone of voice and making eye contact. The intervention is applied during routine care (cleaning, diapering, weighing, etc.) and aims to provide the baby with a sense of security, calmness, and continuity. The nurse uses encouraging and loving expressions, mentioning the baby's name; environmental stimuli (noise, light) are reduced throughout the intervention, and the sound level is kept between 45-60 dB. The standard care process remains unchanged; only verbal soothing communication is added.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Egenaz Gülten Yaman, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673133
- Sponsor's protocol ID
- ADU-NURSINGF-HYILDIZ-EYAMAN-00
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF VOCAL SOOTHING DURING NURSING CARE ON INFANT STRESS AND PHYSIOLOGICAL PARAMETERS IN THE NEONATAL INTENSIVE CARE UNIT
- ClinicalTrials.gov ID
- NCT07673133
- Acronym / sponsor ID
- ADU-NURSINGF-HYILDIZ-EYAMAN-00
- Conditions
- İnfant Stress
- Keywords
- newborn, stress, care, nurse, soothing voice
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Jun 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.
The aim of this study is to determine the effect of verbal soothing applied by the researcher during routine nursing care in the neonatal intensive care unit on neonatal stress and physiological parameters.
Newborns will be divided into two groups, an intervention group and a control group, using simple randomization. Verbal soothing will be applied to the intervention group during routine nursing care (eye care, oral care, diaper changing, probe placement, weight measurement, body care), while no intervention will be performed on the infants in the control group; only routine care procedures will be applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Verbal soothing intervention in the neonatal intensive care unit is based on the principle of a nurse speaking to the baby from a distance of approximately 20 cm, without a mask, using a calm and compassionate tone of voice and making eye contact. The intervention is applied during routine care (cleaning, diapering, weighing, etc.) and aims to provide the baby with a sense of security, calmness, and continuity. The nurse uses encouraging and loving expressions, mentioning the baby's name; environmental stimuli (noise, light) are reduced throughout the intervention, and the sound level is kept between 45-60 dB. The standard care process remains unchanged; only verbal soothing communication is added.
| Arm | Type | Receives |
|---|---|---|
| Vocal Shooting Group | Experimental | Behavioral: vocal soothingNewborns in this group receive researcher-delivered vocal shooting during nursing care procedures in the NICU. |
| Control Group | No intervention | –Newborns in this group will not undergo any intervention by the researcher; routine care procedures will be applied. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Newborns with a gestational age between 32 0/7 and 36 6/7 weeks
- Newborns with an APGAR score above 6 at 5 minutes
- Newborns weighing over 1000 grams
- Newborns not on mechanical ventilation
- Newborns who have been fed at least one hour prior to care
Key exclusion criteria (3 listed)
- Presence of a condition that prevents the assessment of stress and physiological parameters (birth trauma, intracranial hemorrhage, congenital anomaly, etc.),
- Undergoing an invasive procedure that causes different stress at least one hour before the care (intravenous access, aspiration procedure, etc.),
- Administration of sedatives, opioids, and anticonvulsant drugs before the care.
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 |
|---|---|---|
| vocal soothingPrior to the afternoon routine care in the Neonatal Intensive Care Unit, baseline assessments will be completed by the selected clinical nurse using the Neonatal Stress Scale and Neonatal Follow-up Form. During the approximately 10-minute routine care procedure (eye care, oral care, diaper change, probe repositioning, and weight measurement), the investigator will administer a verbal reassurance intervention. The intervention involves speaking to the newborn calmly, reassuringly, and lovingly from a distance of approximately 20 cm, maintaining eye contact and minimizing environmental stimuli. The volume will be kept between 45-60 dB. Outcome measurements will be repeated by the same nurse 5 minutes after the start of care and 5 minutes after the completion of care. | Behavioural | Vocal Shooting Group |
Primary outcome
Neonatal Stress Assessment Scale
Time frame: The Neonatal Stress Scale will be completed by a pre-assigned nurse approximately 1 minute before care begins, 5 minutes after care starts, and 1 minute after care ends. The same nurse will then complete the stress scale and the newborn follow-up form.
The Neonatal Stress Assessment Scale (NISS) was developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants. The scale consists of 24 items on a 3-point Likert scale, comprising 8 subgroups including facial expression, body color, breathing, activity level, soothing ability, muscle tone, extremities, and posture. Each subgroup is scored from 0 to 2 points. The minimum score is 0, and the maximum is 16. A high score indicates increased stress. The scale is evaluated through observation. It is sufficient for the infant to exhibit only one behavior from each cell in their free-standing space. A high value is valid if the infant exhibits behaviors from two different cell types (for example, if the infant shows signs corresponding to both 1 and 2 points). A stable and regular state indicates a high value of 0.
1 secondary outcome
PHYSIOLOGICAL PARAMETERS
Time frame: Routine nursing care will last approximately 10 minutes. The information sheet will be filled out by a nurse selected from the clinic 1 minute before, in the middle of, and 5 minutes after the routine nursing care for newborns.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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.
Questions about this trial
What is this clinical trial studying?
A study testing vocal soothing in people with İnfant Stress, run by Aydin Adnan Menderes University.
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Egenaz G Yaman (+90 533 327 3144, egenaaz12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Stress Assessment Scale (time frame: The Neonatal Stress Scale will be completed by a pre-assigned nurse approximately 1 minute before care begins, 5 minutes after care starts, and 1 minute after care ends. The same nurse will then complete the stress scale and the newborn follow-up form.). 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 29 Jun 2026.