Multisensory Stimulation in Infants for Eye Examination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2023-07-30

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.

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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.

Conditions

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Premature Retinopathy Pain, Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Multisensorial Stimulation Group

Preterm newborns who will receive multisensory stimulation during the eye examination.

Group Type EXPERIMENTAL

Multisensorial Stimulation

Intervention Type BEHAVIORAL

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.

Control Group

Preterm newborns who will receive routine care during the eye examination

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multisensorial Stimulation

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.

Intervention Type BEHAVIORAL

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.