Multisensory Stimulation in Infants for Eye Examination

Akdeniz University

Status: Completed

Conditions: Pain, Eye; Premature Retinopathy

Treatments: Behavioral: Multisensorial Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05830409

MAKU23-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 32 weeks to 36 months old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Multisensorial Stimulation Group

Experimental group

Description:

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

Treatment:

Behavioral: Multisensorial Stimulation

Control Group

No Intervention group

Description:

Preterm newborns who will receive routine care during the eye examination