The Effect of White Noise and Swaddling on Pain, Heart Rate, and Oxygen Saturation in Term İnfants Undergoing Eye Examinations

NCT06535984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-08-02

No results posted yet for this study

Summary

Eye examinations for vision screening in infants cause pain and stress. Aim: To evaluate the effect of white noise and swaddling on pain, heart rate, and oxygen saturation in term infants undergoing post-discharge eye examinations. This study was conducted with term infants born 30-36 days postpartum who visited the ophthalmologic outpatient clinic for eye screening. A total of 120 term infants were included in the sample, divided into three intervention groups: the white noise group (n=30), the swaddling group (n=30), and the white noise + swaddling group (n=30), along with a control group (n=30). Data were collected by the clinic nurse before the eye examination, 30 seconds into the examination, and at the end of the examination. The Premature Infant Pain Profile (PIPP) scale and pulse oximetry were used for data collection.There was no statistically significant difference in pain scores, heart rates, or oxygen saturation (SpO2) between the intervention and control groups (p\>0.05). In all groups, pain scores and heart rates were higher, and SpO2 values were lower after the ophthalmologic examination than before the examination (p\<0.001).Swaddling + white noise, white noise, and swaddling during the eye examination procedure did not affect reducing infants' pain or improving heart rate and oxygen saturation values.

Conditions

Interventions

OTHER

White Noise

White Noise Group (n=30) The third researcher turned on white noise (rain sound; link: https://www.youtube.com/watch?v=rZeM-HZeneo) before the start of the eye examination and played it to the infants until the end of the examination.

OTHER

Swaddling

Swaddling group (n=30) The third researcher swaddled each infant with its thin blanket. The swaddling involved bringing the infant's left hand close to the left buttock and wrapping it with the upper right end of the blanket. Similarly, she wrapped the baby's right hand with the upper left end of the blanket by bringing it closer to the right hip. She wrapped the baby's legs with the lower part of the blanket, ensuring that the baby's head could move freely.

OTHER

White Noise+Swaddling

White Noise + Swaddling Group (n=30) The third researcher swaddled the infants in this group as described in the swaddling group and turned on the white noise (rain sound; link: https://www.youtube.com/watch?v=rZeM-HZeneo) before the examination started and played it to the infants until the examination was over.

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    collaborator OTHER
  • Tokat Gaziosmanpasa University

    lead OTHER

Principal Investigators

  • Sultan Güner Başara, Dr · Tokat Gaziosmanpaşa University Erbaa Faculty of Health Sciences, Department of Child Health and Diseases, Tokat, Türkiye

  • Hüsniye Çalışır, Prof. Dr. · Aydın Adnan Menderes University Faculty of Nursing Child Health and Diseases Nursing , Aydın, Turkey

  • Emel Bahadır Arsu, Nurse · Department of Ophthalmology, Ankara Bilkent City Hospital, University of Health Sciences, Ankara, Turkey

  • Özdemir Özdemir, Prof. Dr. · Department of Ophthalmology, Ankara Bilkent City Hospital, University of Health Sciences, Ankara, Turkey

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
36 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-24
Primary Completion
2023-04-30
Completion
2023-05-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535984 on ClinicalTrials.gov