Multisensory Stimulation in Infants for Eye Examination

Premature Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05830409
• Other study ID #: MAKU23-1
• Status: Completed
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: December 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 30, 2023
• Est. primary completion date: July 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Premature Retinopathy
• Retinopathy of Prematurity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (2)

Lead Sponsor	Collaborator
Akdeniz University	Burdur Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	Premature Infant Pain Profile (PIPP) to be used to assess newborn pain.	first 30 minutes during procedure
Secondary	Heart rate	defines the newborn's heart rates per minutes.	first 30 minutes during procedure
Secondary	Oksigen saturation	defines the newborn's Oksigen saturation	first 30 minutes during procedure