Procedural Pain in Newborns
Conditions
Keywords
Multisensory Stimulation, Heel Lance, Neonatal Pain, Procedural Pain
Brief summary
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.
Detailed description
Heel blood sampling is a routine procedure used in newborn screening; however, it can produce pain, crying, and short-term changes in physiological parameters such as heart rate and oxygen saturation. Non-pharmacological approaches are commonly used to reduce procedural pain in newborns, but the effects of individual methods may be inconsistent. Multisensory stimulation combines several familiar and comforting sensory inputs and may reduce pain by directing attention away from the procedure, supporting autonomic regulation, and decreasing the stress response. In this study, multisensory stimulation will consist of breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn. Breastfeeding and gentle stroking will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout the procedure. The control condition will reflect supportive routine care, with the newborn held in the mother's arms during heel blood sampling. The study will examine whether this structured multisensory approach reduces procedural pain and crying and supports physiological stability in healthy newborns. Pain, heart rate, and oxygen saturation will be assessed before, during, and after heel blood sampling. Crying duration and total procedure duration will also be recorded. The findings may contribute to the development of a safe, practical, and standardized non-pharmacological approach to pain management during routine newborn procedures.
Interventions
The 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.
Sponsors
Baskent University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Presence of any lower-extremity anomaly * Ongoing monitoring or treatment in the neonatal intensive care unit * Presence of a congenital disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| N-PASS Pain Score | Immediately before, during, and immediately after heel blood sampling. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crying Duration | During the heel blood sampling session. | 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. |
| Heart Rate | Immediately before, during, and immediately after heel blood sampling. | 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. |
| Oxygen Saturation | Immediately before, during, and immediately after heel blood sampling. | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTİlçim Ercan-Koyuncu, PhD
Outcome results
None listed