Multisensory Stimulation in Infants for Eye Examination

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05830409

Enrollment

Registered

2023-04-26

Start date

2023-06-06

Completion date

2023-07-30

Last updated

2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Eye, Premature Retinopathy

Keywords

preterm infants, Multisensorial stimulation

Brief summary

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

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.

Interventions

BEHAVIORALMultisensorial 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

32 Weeks to 36 Months

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026