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).
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.
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.
- Conditions
- Healthy Newborns
- 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 group | Role | What they receive |
|---|---|---|
| White noise group | Experimental | 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. Receives: Other: Kangaroo care and White noise |
| Kangaroo care group | Experimental | Kangaroo 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 group | No intervention | Control 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.
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.
- First posted26 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy NewbornsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zila Özlem KIRBAŞ, Bayburt University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Prof. Bayburt University Faculty of Health Science Department of Nursing/Pediatric Nursing
- ClinicalTrials.gov ID
- NCT06278441
- Acronym / sponsor ID
- Zila Özlem KIRBAŞ
- Conditions
- Healthy Newborns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is parallel-group, randomized controlled.
| Arm | Type | Receives |
|---|---|---|
| White noise group | Experimental | Other: Kangaroo care and White noiseAfter 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. |
| Kangaroo care group | Experimental | Other: Kangaroo care and White noiseKangaroo care was started 15 minutes before heel lancing for newborns included in KCG, and heel lancing was performed. |
| Control group | No intervention | –Control group newborns underwent routine heel lancing, and no intervention was performed. |
Who may qualify
- Ages
- 32 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Infants receiving sedative medications
- Any evidence of dysfunction of the hypothalamic-pituitary-adrenal axis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo care and White noiseCG newborns underwent routine heel lancing, and no intervention was performed. | Other | Kangaroo care group, White noise group |
Primary outcome
Ninety newborns were randomized into three groups (30 in each group).
Time frame: 45-60 minutes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 39243091Kirbas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.