Effect of Using White Noise, Embracing and Facilitated Tucking in Newborns

NCT04837326 | Completed

• 1 other identifier: 24237859-714
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted to evaluate the effect of using white noise, embracing and facilitated tucking on physiological parameters, crying duration and pain during heel lance blood sampling in healthy newborns. This study was a prospective, randomized controlled trial. The study was conducted with healthy newborns who were born between 38 and 42 weeks of gestation. The newborns were divided into 4 groups by the applied pain relief methods during heel lance blood sampling in newborns; embracing(n=40), white noise(n=40), facilitated tucking(n=40) and control group (n=40). The physiological changes were evaluated before and after the procedure. NIPS (Neonatal Infant Pain Scale) was used for pain scoring.

Conditions

Pain

Outcome Measures

Primary Outcomes (5)

• Neonatal Pain

  Neonatal Infant Pain Scale

  15 minutes

• Crying Duration

  Crying durations of the infants.

  15 minutes

• Physiological Parameters 1

  Pulse rate

  15 minutes

• Physiological Parameters 2

  SpO2

  15 minutes

• Physiological Parameters 3

  Respiration rate

  15 minutes

Study Arms (4)

Heel Lance Blood Sampling in Facilitated Tucking Position

EXPERIMENTAL

The infants were put in facilitated tucking position by an experienced newborn nurse. They were put in facilitated tucking position so that their arms and legs were in a flexed midline position close to their trunk in a side-lying position. They were positioned so that they could move their extremities freely. They were held in facilitated tucking position for 120 seconds before the procedure. They were kept in facilitated tucking position until the blood sample was taken from the right heel using a lancet. They were released 60 seconds after the procedure and monitored for 120 seconds. The blood samples were taken by the researcher after inserting the lancet in the first try.

Other: Heel Lance Blood Sampling in Facilitated Tucking Position

Heel Lance Blood Sampling When the Infant is Embraced by the Mother

EXPERIMENTAL

The mother, whose privacy was protected, embraced the infant for 120 seconds before the procedure. The infant was embraced by the mother during the heel lance blood sampling from the left heel using a lancet. They were released 60 seconds after the procedure and monitored for 120 seconds. The blood samples were taken by the researcher after inserting the lancet in the first try.

Other: Heel Lance Blood Sampling When the Infant is Embraced by the Mother

Heel Lance Blood Sampling Using White Noise

EXPERIMENTAL

The 'Don't Let Your Baby Cry, PT.2' track from the 'Colic' album by Orhan Osman using the 'The Happiest Baby' album by Dr. Harvery Karp which was composed only of intrauterine was made listened to the infants via Xperia Ultra Mp3 Player for 120 seconds before and 120 seconds after the heel lance blood sampling procedure. While white noise was made listened to the infants before, during and after the procedure, Digital Sound LeverMeter brand noise measurement device was put at a distance of 50 cm from the infant and the ambient noise level was adjusted as 55 dB. The blood samples were taken by the researcher after inserting the lancet in the first try.

Other: Heel Lance Blood Sampling Using White Noise

Control Group

NO INTERVENTION

Suitable environmental conditions (ambient temperature, silent environment, etc.) were ensured in the study room for the infant's comfort. A saturation probe was inserted to the right wrist of the infant to monitor him/her. A video record was taken for 120 seconds without any intervention to the infants before and after the heel lance blood sampling procedure. The blood samples were taken by the researcher after inserting the lancet in the first try. Heel lance was performed in clinical routine for preterm infants in the control group.

Interventions

Heel Lance Blood Sampling in Facilitated Tucking Position OTHER

Heel Lance Blood Sampling in Facilitated Tucking Position

Heel Lance Blood Sampling When the Infant is Embraced by the Mother OTHER

Heel Lance Blood Sampling When the Infant is Embraced by the Mother

Heel Lance Blood Sampling Using White Noise OTHER

Heel Lance Blood Sampling Using White Noise

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• gestational age between 38 and 42 weeks,
• birth weight of 2500 - 4000 g,
• Apgar score of 8 and higher at 1st and 5th minute,
• having breastfed at least half an hour before the procedure,
• not showing any disease symptom,

You may not qualify if:

• having congenital anomaly,
• getting a good hearing test result
• having received any invasive intervention other than Vitamin K and Hepatitis B vaccine.

Sponsors & Collaborators

• Ordu University: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Yavuz ÖZORAN, Professor

  Avrasya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof. Dr

Model Details: This randomized-controlled experimental study was performed to evaluate the effect of white noise, embracing and facilitated tucking on pain during heel lance blood sampling in newborns.

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: May 1, 2016
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share