EFFECT OF VOCAL SOOTHING ON STRESS IN NEONATES DURING NURSING CARE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vocal soothing.
- Who it may be relevant to
- Registry conditions: İnfant Stress. Basic parameters: 0 Days — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
THE EFFECT OF VOCAL SOOTHING DURING NURSING CARE ON INFANT STRESS AND PHYSIOLOGICAL PARAMETERS IN THE NEONATAL INTENSIVE CARE UNIT
Overview
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.
Interventions
- 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 fr
Primary outcome measures
- 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.]
Secondary outcome measures (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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07673133 · ADU-NURSINGF-HYILDIZ-EYAMAN-00