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

NCT06278441 | Completed

• 1 other identifier: Zila Özlem KIRBAŞ
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Newborns

Outcome Measures

Primary Outcomes (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).

  45-60 minutes

Study Arms (3)

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.

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.

Other: Kangaroo care and White noise

Control group

NO INTERVENTION

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

Interventions

Kangaroo care and White noise OTHER

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

Kangaroo care group; White noise group

Eligibility Criteria

• Age: 32 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Bayburt University

Bayburt, 69100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39243091 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Model Details: This study is parallel-group, randomized controlled.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 26, 2024
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: February 10, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)