Multisensory Stimulation in Infants for Eye Examination

Study Overview
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Brief Summary
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This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns. It was planned as a randomized controlled trial. trying to reach 80 newborns in total. Multisensory stimulation will be applied to the intervention group during the examination. In the control group, routine care will be applied during the examination.

Detailed Description
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Preterm retinopathy may develop due to intubation in preterm newborns. Therefore, this population undergoes eye examinations at regular intervals. This procedure is painful procedure for babies. Nurses can apply interventions to reduce this pain. In this study, it was planned to apply multisensory stimulation to reduce the pain of the newborn. A randomized controlled trial and routine care were planned in the control group. Neonatal pain will be assessed using the PIPP scale.

Official Title
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Effect of Multisensory Stimulation on Pain During the Preterm Infant's Eye Examination

Conditions
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Premature Retinopathy, Pain, Eye

Intervention / Treatment
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* Behavioral: Multisensorial Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: According to the registry, premature neonates with a gestational age of ≤ 32 weeks or newborns with a birth weight of < 1500 g. Newborns undergoing a first-time eye exam to screen for retinopathy of prematurity. Exclusion Criteria: Newborns who need CPR during the examination. Newborns experience apnea during the examination.

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multisensorial Stimulation Group<br>Preterm newborns who will receive multisensory stimulation during the eye examination. | Behavioral: Multisensorial Stimulation<br>* Strategies such as touching, calling, making sense of smell, entering the eye area, and activating the sense of taste will be applied to activate the five senses of the newborn.<br>|
| No Intervention: Control Group<br>Preterm newborns who will receive routine care during the eye examination | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | Premature Infant Pain Profile (PIPP) to be used to assess newborn pain. | first 30 minutes during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | defines the newborn's heart rates per minutes. | first 30 minutes during procedure | 
| Oksigen saturation | defines the newborn's Oksigen saturation | first 30 minutes during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infants, Multisensorial stimulation