EFFECT OF VOCAL SOOTHING ON STRESS IN NEONATES DURING NURSING CARE

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.

Study Overview

• Status: Not yet recruiting
• Conditions: İnfant Stress
• Intervention / Treatment: Behavioral: vocal soothing

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Egenaz G Yaman; Phone Number: +90 533 327 3144; Email: egenaaz12@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vocal Shooting Group; Newborns in this group receive researcher-delivered vocal shooting during nursing care procedures in the NICU.	Behavioral: vocal soothing; 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.
No Intervention: Control Group; Newborns in this group will not undergo any intervention by the researcher; routine care procedures will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: stress; nurse; newborn; care; soothing voice
• Other Study ID Numbers: ADU-NURSINGF-HYILDIZ-EYAMAN-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No