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NCT Number: NCT05830409

Multisensory Stimulation in Infants for Eye Examination

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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Key information

Conditions

Premature Retinopathy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Manifestations Eye Pain Infant, Newborn, Diseases Infant, Premature, Diseases Neurologic Manifestations Pain Pain, Eye Pathological Conditions, Signs and Symptoms Retinal Diseases Retinopathy of Prematurity Signs and Symptoms

Age range

32 week–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multisensorial Stimulation

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.

Primary outcomes

  1. Pain level

    Time frame: first 30 minutes during procedure

    Premature Infant Pain Profile (PIPP) to be used to assess newborn pain.

Secondary outcomes

  1. Heart rate

    Time frame: first 30 minutes during procedure

    defines the newborn's heart rates per minutes.

  2. Oksigen saturation

    Time frame: first 30 minutes during procedure

    defines the newborn's Oksigen saturation

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Collaborators

  • Burdur Mehmet Akif Ersoy University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2023
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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