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

NCT06535984 | Completed

• 1 other identifier: Tokat Gaziosmanpaşa University
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

Eye examination; İnfant; Pain; Nonpharmacologic

Outcome Measures

Primary Outcomes (3)

• The Premature Infant Pain Profile total pain score

  The Premature Infant Pain Profile (PIPP); The scale assesses seven items: gestational age, behavioral status, highest heart rate, lowest oxygen saturation value, forehead wrinkling, squinting, and widening of the wings of the nose. Each item is scored from 0 to 3 (from good to bad), with higher scores indicating greater pain. The total PIPP score ranges from 0 to 21, where 0-6 points indicate mild pain, 7-12 points indicate moderate pain, and 13-21 points indicate severe pain

  Eye examination beginning and end (approximately 1-1.5 minutes)

• heart rate value

  Eye examination beginning and end (approximately 1-1.5 minutes)

• oxygen saturation value

  Eye examination beginning and end (approximately 1-1.5 minutes)

Study Arms (4)

white noise

EXPERIMENTAL

In the research, white noise was provided to the experimental group

Other: White Noise

swaddling

EXPERIMENTAL

In the research, swaddling was provided to the experimental group

Other: Swaddling

White Noise + Swaddling group

EXPERIMENTAL

In the research, White Noise + Swaddling group were provided to the experimental group

Other: White Noise+Swaddling

Control group

NO INTERVENTION

The control group received routine care

Interventions

White Noise OTHER

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.

white noise

Swaddling OTHER

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.

swaddling

White Noise+Swaddling OTHER

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.

White Noise + Swaddling group

Eligibility Criteria

• Age: 30 Days - 36 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• infants with a gestational age of \>37 6/7 weeks,
• birth weight ≥2000 g,
• th minute Apgar score ≥7,
• aged 30-36 days postpartum,
• undergoing their first eye examination

You may not qualify if:

• a history of hospitalization in the neonatal intensive care unit,
• postnatal resuscitation,
• presence or suspicion of a congenital and/or genetic disease,
• hearing problems, surgical operation for any reason,
• systemic analgesic administration within the last six hours.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead
• Ankara City Hospital Bilkent: collaborator

Study Sites (1)

Sultan Güner Başara

Tokat Province, Erbaa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sultan Güner Başara, Dr

  Tokat Gaziosmanpaşa University Erbaa Faculty of Health Sciences, Department of Child Health and Diseases, Tokat, Türkiye

  STUDY DIRECTOR

• Hüsniye Çalışır, Prof. Dr.

  Aydın Adnan Menderes University Faculty of Nursing Child Health and Diseases Nursing , Aydın, Turkey

  PRINCIPAL INVESTIGATOR

• Emel Bahadır Arsu, Nurse

  Department of Ophthalmology, Ankara Bilkent City Hospital, University of Health Sciences, Ankara, Turkey

  PRINCIPAL INVESTIGATOR

• Özdemir Özdemir, Prof. Dr.

  Department of Ophthalmology, Ankara Bilkent City Hospital, University of Health Sciences, Ankara, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the data collection process, the person collecting data was not blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Erbaa Faculty of Health Sciences, Department of Nursing

Model Details: Participants were divided into four groups: three intervention groups and one control group. Infants were assigned to these groups using simple random sampling to ensure homogeneity and prevent selection bias. The sample size was calculated using the G-Power 3.0.10 program. With a confidence interval (CI) of 95%, α = 0.05, effect size = 0.159, and power (1 - β) = 0.80, a total sample size of 108 was calculated for the four groups, with at least 27 infants in each group. The study included 120 infants divided into the swaddling group (n=30), white noise group (n=30), white noise + swaddling group (n=30), and control group (n=30)

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: August 2, 2024
• Study Start: October 24, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 15, 2023
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)