Effect of Maternal Odor and Kangaroo Care on Serum Cortisol and Comfort Levels in Preterm Infants: a Randomised Trial

NCT05607706 | Completed

• 1 other identifier: anka
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Aims and objectives: Studies on stress are generally aimed at young children and infants. However, in the neonatal period, "especially in preterm babies", this issue was not given enough attention and was almost completely ignored. Background: They are exposed to different stressors. Too much stress will increase their problems in their future lives. Design: This study was planned as a randomized study to determine the effects of Kangaroo Care and mother scent application on toxic stress in preterm infants in the Neonatal Intensive Care Unit environment and to create evidence-based recommendations regarding these applications. Methods: Research data were collected from a total of 92 preterm babies born. Babies were divided into 3 groups, those who never met their mothers, only mother scent group and KC group. The mother's undershirt was used as the maternal odor. Vital signs, blood cortisol levels and Preterm Infant Comfort Scale scores were determined and recorded each group.The data were evaluated by statistical analysis. The CONSORT checklist for reporting qualitative research was used. Results: In the group that never encountered mother and mother odor, Preterm Infant Comfort Scale, blood cortisol level and vital signs showed severe stress. It was found that maternal odor is effective in reducing this stress, but kangaroo care is much more effective in preventing stress. Conclusion: if premature babies are deprived of their mother, the stress may be exposed to reaches toxic levels. It was determined that kangaroo care application during the treatment of these babies is a more effective method in reducing stress than the maternal odor application method. Relevance to clinical practice: The results of this study will contribute to nurses' use of kangaroo care and maternal odor in the care of preterm babies to prevent stress and related complications.Therefore, it will improve the quality of care of preterm babies in the NICU.

Conditions

Preterm Birth Complication; Stress Related Disorder; Cortisol Overproduction

Keywords

preterm infant; maternal odor; kangaroo care; cortisol

Outcome Measures

Primary Outcomes (1)

• Mother odor relieves stress

  Exposing preterm infants to maternal odor reduces stress for infants in the NICU exposed to a various stressors.

  6 months

Secondary Outcomes (1)

• Kangaroo care relieves stress

  2 months

Study Arms (3)

Control

NO INTERVENTION

families were not allowed to enter the NICU

Maternal Odor

ACTIVE COMPARATOR

Babies compared only to the mother's odor

Behavioral: Exposure to maternal odor

Kangaroo care

ACTIVE COMPARATOR

Babies given kangaroo care

Behavioral: Exposure to maternal odor

Interventions

Exposure to maternal odor BEHAVIORAL

Exposure to maternal odor; the shirt worn by the mother is put in the baby's incubator, kangaroo care; mother lays her baby naked between her breasts

Also known as: Kangaroo care

Kangaroo care; Maternal Odor

Eligibility Criteria

• Age: 1 Minute - 1 Month
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants hospitalized in the NICU for at least 15 days (babies born less than 37 weeks of gestation, greater than 28 weeks of gestation and between 1000-2500 g), babies with a first-minute Apgar score of 7 and above, and with no feeding problems, and who do not have brain-pituitary-adrenal axis problems, babies without congenital defects, and without respiratory problems (endotracheal intubation, mechanical ventilation support or nasal continuous positive airway pressure application), and with no cardiological problems, and who have not undergone surgery, and who have been given kangaroo care by a neonatal specialist, and with no suspected or no sepsis diagnosis, who are not treated with analgesics, sedatives, muscle relaxants because it may affect/pressure the stress situation, and whose mothers do not have a mental and physical problem/condition/health problem that prevents them from giving kangaroo care

You may not qualify if:

• constitute the research population, were determined as follows. Babies who had a health problem during the study and had a hospitalization period of less than 15 days in the NICU were excluded from the study

Sponsors & Collaborators

• Istanbul Nisantasi University: lead

Study Sites (1)

Nisantasi University

Istanbul, 34398, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ACTH Syndrome, Ectopic; Premature Birth

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alev Sivasli

  Nisantasi University, İstanbul, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: This research; It was planned as a Randomized Controlled Experimental Study. In the study, the effect of kangaroo care and maternal odor, which are independent variables, on the toxic stress level of preterms, which is the dependent variable, was tried to be determined. The study was carried out NICU at Anka Hospital, in Gaziantep, Turkey. The sample calculation of the research was made using the "Jamovi 1.8" program. The significance level was taken as 0.05 according to the power analysis performed to determine the sufficient sample size, and it was calculated that at least 30 patients should be included in each patient group in order to have a minimum theoretical power of 0.7. The study was planned to be conducted with a total of 135 patients, with 45 patients in each group.

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 7, 2022
• Study Start: January 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: by email

Locations

TU (1)