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Healthy NewbornsNCT06278441

The Effect of White Noise and Kangaroo Care Practices on Stress Parameters in Newborns With Heel Lancing

A study testing Kangaroo care and White noise in people with Healthy Newborns, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

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

Aim: It is an examination of the effects of white noise and kangaroo care on some physiological parameters (pulse, saturation, crying duration) and stress markers (cortisol and glucose-regulated protein 78 (GRP78)) in heel lancing in newborns. Read more about this study

Who is it for?
Ages 32 to 72 hoursHealthy volunteers can take part
Conditions the study is for
Healthy Newborns
What is being tested?
Kangaroo care and White noise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2023to 10 Feb 2024
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 32 to 72 hours
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Gestational age ≥37 weeks
  • Birth weight >2500 g
  • Apgar score ≥8 at the 1st minute and 5th minute
  • No anatomical or physiological problems
  • No congenital or acquired hearing-related disease
  • Newborns were born who had no malformations
  • No family members with hearing loss that started in childhood

Who cannot join

  • Infants receiving sedative medications
  • Any evidence of dysfunction of the hypothalamic-pituitary-adrenal axis

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bayburt University

    Bayburt, 69100

Other trials in Turkey (Türkiye)

About this study

Official title: Assistant Prof. Bayburt University Faculty of Health Science Department of Nursing/Pediatric Nursing

Aim: It is an examination of the effects of white noise and kangaroo care on some physiological parameters (pulse, saturation, crying duration) and stress markers (cortisol and glucose-regulated protein 78 (GRP78)) in heel lancing in newborns.

Methods: In this parallel-group, randomized controlled study, healthy newborns with a gestational age of ≥37 weeks, birth weight of >2500 g, and an Apgar score of ≥8 at the 1st minute and 5th minute were included. White noise and kangaroo care were applied to newborns in the intervention groups for heel lancing.

Read more

Results: Ninety newborns were randomized into three groups (30 in each group). A statistically significant difference was determined between the median values of total crying time according to groups (p<0.001). A statistically significant difference was determined between the median values of pulse measurements according to the interaction of group and time (p<0.001). A statistically significant difference was determined between the median values of saturation measurements according to groups (p=0.001). A statistically significant difference was determined between the mean values of cortisol and GRP78 measurements according to the group and time interaction (p<0.001).

Conclusion: It was concluded that white noise and kangaroo care help reduce newborns' stress in the case of heel lancing.

Read the detailed description

This study aimed to examine the effects of white noise and kangaroo care during heel lancing in newborns on some physiological parameters (pulse, saturation, crying duration) and stress markers (cortisol and GRP78).

Study Design The study was carried out with a randomized controlled experimental design. The research was conducted in the gynecology service of a hospital between January and September 2023. In Türkiye, metabolic screenings are carried out in hospitals within the first 36-72 hours after birth, before the newborn is discharged, and in Family Health centers on the 5th day. The reason why we chose the sample group from the hospital is to both monitor physiological parameters appropriately and minimize sample loss. There are 5 neonatal nurses and 3 pediatricians working in the hospital's gynecology service. The Bayburt University Ethics Committee (2022/334) approved the study.

Participants All babies (N = 90) were randomly divided into three groups (Figure 1: Consort Flow Diagram) using a computer program (http://www.randomizer.org) and the first participants were selected and assigned by lottery method (White noise group (WNG) (1), Kangaroo care group (KCG) (2), Control group (CG) (3)). After the initial assignments were made, newborns were assigned to groups according to the numbers given by random.

Data collection tools Data; "Mother and Baby Introductory Information Form (mother's age, educational status, and several children, mode of birth and newborn's Apgar score, gestational age, gender, birth weight, and height)," "Newborn Follow-up Form (crying duration, pulse (heart rate)" and oxygen saturation before, during and after the procedure; for recording stress saliva biomarker (cortisol, GRP78) levels before and after the procedure)", "Portable Monitor," "Stopwatch (Apple Watch/JAPAN)," "Portable speaker," "Decibel" measurement device (Benetech GM1351/TURKIYE", "Orhan Osman's Colic album - Don't Let Your Baby Cry 2 (Utilizing the sounds inside the uterus in Dr. Harvey Karp's album "The Happiest Baby" and combining these sounds with his compositions, 'Colic' album)," "Salimetrics SalivaBio Infant's Swab (SIS)" (It is a material used to collect the saliva of babies and newborns under six months of age. Its features are that saliva is obtained by keeping it under the tongue and in the corners of the mouth for 60-90 seconds and placed in the storage tube.) gathered.

Procedure and interventions Before the heel lancing, the mothers of newborns who met the sampling criteria were informed about the research, their written and verbal consent was obtained, and their information was recorded on the mother and baby descriptive form before the procedure. With standardization in the procedure technique, the environmental factors to which the newborns were exposed were ensured to be the same in all groups (needle tip (21 gauge, temperature (24-25 °C), light, and noise). Half an hour before the heel lancing, the newborns were fed, and their diapers were changed. It was ensured that the newborns were not exposed to painful procedures before the procedure. Crying times were monitored with a stopwatch from the beginning of the procedure until the end of the procedure and recorded in the follow-up form. Physiological parameters (pulse, O2 saturation) were monitored with a portable monitor device before, during, and after the procedure and recorded in the follow-up form. Saliva samples were collected just before the heel lancing and 20 minutes after the procedure. Necessary white noise and kangaroo care protocols were initiated before the heel lancing. For the interventions to be performed on all groups, the procedure was applied to newborns between 7:00 and 10:00 in the morning. The same neonatal nurse performed the heel lancing in each group. The researchers conducted applications, monitoring of physiological parameters, and saliva collection. Kangaroo care was started 15 minutes before heel lancing for newborns included in KCG, and heel lancing was performed. The application was carried out according to WHO's (2003) kangaroo care guide.16 After the newborns in the WNG group were taken to the blood collection department, white noise (55 dB) was played through a speaker standing 1 meter away from the newborn. The sound level was adjusted to 55 dB with a decibel meter. A heel lancing was performed after the newborn started listening to white noise and calmed down. CG newborns underwent routine heel lancing, and no intervention was performed. Due to the nature of the intervention, blinding could not be done for the participants, and the two researchers who collected the data, but the statistician and two other researchers who analyzed the results were unaware of group allocation.

Saliva collection and measurement To collect samples, the research team held one end of the saliva swab (Salimetrics® SalivaBio Infant Swab, Carlsbad, CA) and placed the other end of the swab against the newborn's buccal mucosa or sublingually to absorb saliva. Immediately after saliva collection, the swabs were labeled in storage tubes.17 The saliva samples obtained as a result of the study were transferred to Eppendorf tubes and centrifuged at 1500 g for 15 minutes in a refrigerated centrifuge (NF 1200R, NUVE, Ankara, TURKIYE) in the laboratory and then stored at -30°C until cortisol hormone and GRP78 analyzes were performed on the saliva samples. The commercial kits used in measurements are human-specific and for cortisol level (BT LAB, Cat.No E 1 003Hu, CHINA); (SinoGeneClon, ELISA Kit Product code: SG-20252, CHINA) was used for GRP78 level measurement.

Being tested
Kangaroo care and White noise

What participants receive

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

  • Kangaroo care and White noiseOther

    CG newborns underwent routine heel lancing, and no intervention was performed.

Study groups in NCT06278441
Study groupRoleWhat they receive
White noise groupExperimentalAfter the newborns in the WNG group were taken to the blood collection department, white noise (55 dB) was played through a speaker standing 1 meter away from the newborn. The sound level was adjusted to 55 dB with a decibel meter. A heel lancing was performed after the newborn started listening to white noise and calmed down.
Receives: Other: Kangaroo care and White noise
Kangaroo care groupExperimentalKangaroo care was started 15 minutes before heel lancing for newborns included in KCG, and heel lancing was performed.
Receives: Other: Kangaroo care and White noise
Control groupNo interventionControl group newborns underwent routine heel lancing, and no intervention was performed.

What is being measured

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

  1. Ninety newborns were randomized into three groups (30 in each group).

    A statistically significant difference was determined between the median values of total crying time according to groups (p<0.001). A statistically significant difference was determined between the median values of pulse measurements according to the interaction of group and time (p<0.001). A statistically significant difference was determined between the median values of saturation measurements according to groups (p=0.001). A statistically significant difference was determined between the mean values of cortisol and GRP78 measurements according to the group and time interaction (p<0.001).

    Measured: 45-60 minutes

Timeline

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

  1. First posted26 Feb 2024
  2. Study start1 Jan 2023
  3. Primary completion1 Sep 2023
  4. Study completion10 Feb 2024

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 study is parallel-group, randomized controlled.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06278441
Sponsor's protocol ID
Zila Özlem KIRBAŞ
Status last verified
Feb 2024
First submitted
12 Feb 2024
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kirbas ZO, OdabasI Aktas E, Bayraktar B, Ozkan H. Effect of kangaroo mother care and white noise on physiological-stress parameters in heel lancing: randomized controlled study. BMC Pediatr. 2024 Sep 6;24(1):568. doi: 10.1186/s12887-024-05033-1.

    PubMed 39243091

Questions about this trial

What is this clinical trial studying?

A study testing Kangaroo care and White noise in people with Healthy Newborns, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

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 7 inclusion and 2 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Ninety newborns were randomized into three groups (30 in each group). (time frame: 45-60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06278441, which also lists 1 linked publication.

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 26 Feb 2024.

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