EFFECT OF VOCAL SOOTHING ON STRESS IN NEONATES DURING NURSING CARE

NCT07673133 | Not Yet Recruiting

• 1 other identifier: ADU-NURSINGF-HYILDIZ-EYAMAN-00
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

newborn; stress; care; nurse; soothing voice

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

Vocal Shooting Group

EXPERIMENTAL

Newborns in this group receive researcher-delivered vocal shooting during nursing care procedures in the NICU.

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.

Interventions

vocal soothing BEHAVIORAL

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.

Vocal Shooting Group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Central Study Contacts

Egenaz G Yaman

CONTACT

+90 533 327 3144; egenaaz12@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share