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PainNCT04837326

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

A study testing Heel Lance Blood Sampling in Facilitated Tucking Position, Heel Lance Blood Sampling When the Infant is Embraced by the Mother and Heel Lance Blood Sampling Using White Noise in people with Pain, run by Ordu University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 28 daysHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Heel Lance Blood Sampling in Facilitated Tucking Position, Heel Lance Blood Sampling When the Infant is Embraced by the Mother and Heel Lance Blood Sampling Using White Noise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
No sites listed yet
Study dates
1 May 2016to 30 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 28 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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,

Who cannot join

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

About this study

Official title: Effect of Using White Noise, Embracing and Facilitated Tucking on Physiological Parameters, Crying Duration and Pain During Heel Lance Blood Sampling in Newborns: Randomized Controlled Trial

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.

Read the detailed description

This study aimed to investigate the effect of white noise, embracing and facilitated tucking on pain during heel lance blood sampling in newborns.

METHODS 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.

Setting and sample:

The study sample consisted of healthy newborns who were born and monitored in the Neonatology Unit of a university hospital. The sample inclusion criteria were 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, not having congenital anomaly, getting a good hearing test result and not having received any invasive intervention other than Vitamin K and Hepatitis B vaccine.

Sample size:

Following previous studies, G*Power (v3.1.9.2) was deployed to determine the sample number. According to Jacob Cohen's effect size coefficients, assuming that evaluations carried out among four independent groups would have a large effect size (d=0.40), it was determined that the groups should comprise least 40 people, with a total of 160, for levels of α=0.05 and 1-β=0.95 (80% power). Children were assigned to 4 subgroups through randomization performed using a computer program (www.randomizer.org): group 1 was the control group children who received no intervention for pain relief (n = 40); group 2 received facilitated tucking (n = 40); group 3 received embracing (n = 40); and group 4 received white noise (n = 40).

Intervention:

The mothers were informed by the researcher about the purpose of the study before collecting data. The infants were held by their mothers so that their faces, arms, legs and respirations could be easily viewed by the camera to evaluate the NIPS. All heel lance procedures were performed by the same nurse working on the day shift (who had 6-year NICU experience). The heel lance blood sampling point (outer side of the left heel), the lancet used in the procedure, the sampling technique, and the antiseptic solution (70% alcohol) used in for the procedure were the same for all the groups. The heel lance blood sampling procedure was performed by the researcher in the blood sampling room in the Neonatology ward. 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. The behavioral responses to pain and crying durations of all the responses were recorded by camera before, during and after the procedure. Then, these records were played and the NIPS scores and crying durations of the infants were evaluated. The physiological changes were recorded before, during and after the procedure, respectively. In the data collection stage, 3 persons (nurse putting the infant in facilitated tucking position, nurse taking blood sample, researcher shooting video) were required for facilitated tucking position; 2 persons (nurse taking blood sample and researcher shooting video) for maternal embracing since the infant was held by the mother and 2 persons (nurse taking blood sample and researcher shooting video) for white noise.

Heel Lance Blood Sampling in Facilitated Tucking Position:

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.

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

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.

Heel Lance Blood Sampling Using White Noise:

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.

Control Group:

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.

Conditions
Pain
Being tested
Heel Lance Blood Sampling in Facilitated Tucking Position, Heel Lance Blood Sampling When the Infant is Embraced by the Mother, Heel Lance Blood Sampling Using White Noise
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heel Lance Blood Sampling in Facilitated Tucking PositionOther

  • Heel Lance Blood Sampling When the Infant is Embraced by the MotherOther

  • Heel Lance Blood Sampling Using White NoiseOther

Study groups in NCT04837326
Study groupRoleWhat they receive
Heel Lance Blood Sampling in Facilitated Tucking PositionExperimentalThe 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.
Receives: Other: Heel Lance Blood Sampling in Facilitated Tucking Position
Heel Lance Blood Sampling When the Infant is Embraced by the MotherExperimentalThe 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.
Receives: Other: Heel Lance Blood Sampling When the Infant is Embraced by the Mother
Heel Lance Blood Sampling Using White NoiseExperimentalThe '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.
Receives: Other: Heel Lance Blood Sampling Using White Noise
Control GroupNo interventionSuitable 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal Pain

    Neonatal Infant Pain Scale

    Measured: 15 minutes

  2. Crying Duration

    Crying durations of the infants.

    Measured: 15 minutes

  3. Physiological Parameters 1

    Pulse rate

    Measured: 15 minutes

  4. Physiological Parameters 2

    SpO2

    Measured: 15 minutes

  5. Physiological Parameters 3

    Respiration rate

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start1 May 2016
  3. Primary completion30 Dec 2017
  4. Study completion30 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04837326
Sponsor's protocol ID
24237859-714
Status last verified
Apr 2021
First submitted
4 Apr 2021
Last updated
14 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Results

Questions about this trial

What is this clinical trial studying?

A study testing Heel Lance Blood Sampling in Facilitated Tucking Position, Heel Lance Blood Sampling When the Infant is Embraced by the Mother and Heel Lance Blood Sampling Using White Noise in people with Pain, run by Ordu University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal Pain (time frame: 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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