Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05607706 |
| Other study ID # |
anka |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
Nisantasi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
About 15 million babies are born preterm every year around the world(Blencowe et al., 2013).
This corresponds to more than one in every 10 babies born alive(Lincetto & Banerjee, 2020).
This situation, which is a serious problem all over the world, causes approximately 1 million
children to die from complications related to preterm birth before the age of 5 years(Walani,
2020). Many of the living preterm babies also develop psychological and physical problems
that require follow-up in adolescence, adulthood or lifelong (Kajantie et al., 2021; Manninen
et al., 2022). Compared to term babies, preterm babies continue their lives with lower motor
and neurological abilities in the later periods of their lives(Wolke et al., 2019). In
addition, unlike full-term babies, hospitalization in the neonatal intensive care unit (NICU)
after birth causes them to be exposed to many stress-inducing factors such as noise, nursing
intervention and light (Larkin et al., 2019).
Stress is a term used to describe th eresponse of a person to both positive and negative
events that he encounters daily throughout his life. Stressors can be physical, emotional,
environmental or theoretical. Stressors can all affect the body's stress response equally.
Stress response, also known as "fight or flight" response or general adaptation syndrome,
includes physiological changes that ocur with an individual's encounter with or perceived
stress. This stres response is a result of stimulation of the sympathetic nervous system
resulting in a cascade of neuro-endocrine-immune responses, with reproducible physiologic
effects that include an increase in respirations, heart rate, blood pressure, and overall
oxygen consumption (Franke, 2014). Physiological consequences of stress,
hypothalamus-pituitary-adrenal cortisol are regulated. In response to a stressor, there is an
increase in the secretion of glucocorticoids, especially cortisol(Gunnar et al., 1991).There
are three different types of stress. Positive stress; this type of stress is a normal part of
life, a positive and normal stress response, and is essential for a child's growth and
development. Positive stress responses are infrequent, short-lived, and mild. Tolerable
stress; the stress that can be tolerated is more severe, frequent, or persistent. The body
responds to a greater degree, and these biochemical responses have the potential to
negatively affect brain architecture. Toxic stress; toxic stress leads to prolonged
stimulation of the stress response with the body's inability to fully recover(Bergman, 2019a;
Weber & Harrison, 2019). It differs from a normal stress response because there is a lack of
caregiver support, reassurance, or emotional attachment. Inadequate caregiver support
prevents the stress response from being supported or the body returning to its initial
functions.This stress causes the development of many other problems in addition to the
increase in the problems that will develop due to preterm birth in their future lives.
Therefore, minimizing this stress is of vital importance for preterm infants and their
families (WHO, 2017; Ylijoki et al., 2020).
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. Researching this issue will help to make serious changes and
corrections in the working principles of the neonatal intensive care unit. For this reason,
this study was planned to determine the effects of Kangaroo Care (KC) and Maternal Odor on
preterm infants on Toxic Stress and to create evidence-based recommendations about these
practices in the NICU setting.
