EFFECT OF VOCAL SOOTHING ON STRESS IN NEONATES DURING NURSING CARE
Conditionİnfant Stress
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorAydin Adnan Menderes University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
vocal soothing
BehavioralPrior 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Vocal Shooting GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
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 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.
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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