Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns
ConditionProcedural Pain in Newborns
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorBaskent University
About this trial
This randomized controlled study will evaluate whether multisensory stimulation can reduce pain in healthy newborns during heel blood sampling. Newborns will be assigned to either a multisensory stimulation group, which includes breastfeeding, gentle stroking, maternal singing, and eye contact, or a control group in which the procedure will be performed while the newborn is held in the mother's arms. Pain scores, crying duration, heart rate, oxygen saturation, and procedure duration will be compared between the groups.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy newborns aged 0-28 days
Newborns receiving routine monitoring and care with their mothers in the hospital's newborn care unit
Written informed consent provided by the newborn's parent or legal representative
Disqualifiers
Presence of any lower-extremity anomaly
Ongoing monitoring or treatment in the neonatal intensive care unit
Presence of a congenital disease
Trial design
Design model
Parallel
Treatments tested in this trial
Multisensory Stimulation
Other interventionThe multisensory stimulation intervention consists of four components: breastfeeding, gentle stroking, maternal singing or lullaby, and eye contact. Breastfeeding will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. During the same 15-minute period, the mother will gently stroke the newborn's leg from which the heel blood sample will be obtained. Throughout the heel blood sampling procedure, the mother will sing a lullaby or song in a soft and calm voice and maintain continuous eye contact with the newborn. No standardized song or lullaby will be prescribed, and the sound level will remain within the range of natural mother-newborn communication.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Multisensory Stimulation GroupExperimental treatment 1 intervention
Group B: Mother's Arms Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
N-PASS Pain Score
Newborn pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS). The scale evaluates crying or irritability, behavioral state, facial expression, extremity tone or body tension, and changes in vital signs. Higher pain scores indicate greater pain or agitation.
Time frame
Immediately before, during, and immediately after heel blood sampling.Secondary outcomes
1
Crying Duration
The total duration of crying associated with heel blood sampling will be measured using a stopwatch and recorded in seconds. A shorter crying duration indicates a more favorable outcome.
Time frame
During the heel blood sampling session.2
Heart Rate
Heart rate will be measured non-invasively using a bedside pulse oximeter and recorded as beats per minute. Heart rate values will be assessed to determine physiological responses to heel blood sampling and the multisensory stimulation intervention.
Time frame
Immediately before, during, and immediately after heel blood sampling.3
Oxygen Saturation
Peripheral oxygen saturation will be measured non-invasively using a bedside pulse oximeter and recorded as a percentage. Higher and more stable oxygen saturation values indicate a more favorable physiological response.
Time frame
Immediately before, during, and immediately after heel blood sampling.Other outcomes
1
Procedure Duration
The total duration of the heel blood sampling procedure will be measured using a stopwatch and recorded in seconds.
Time frame
During a single heel blood sampling procedureSponsors and contacts
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Source ClinicalTrials.gov