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NCT Number: NCT07673133

EFFECT OF VOCAL SOOTHING ON STRESS IN NEONATES DURING NURSING CARE

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.

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Key information

Conditions

İnfant Stress

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Egenaz G Yaman

CONTACT

[email protected]

+90 533 327 3144

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

THE EFFECT OF VOCAL SOOTHING DURING NURSING CARE ON INFANT STRESS AND PHYSIOLOGICAL PARAMETERS IN THE NEONATAL INTENSIVE CARE UNIT

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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