Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05607706
Study type Interventional
Source Nisantasi University
Contact
Status Completed
Phase N/A
Start date January 1, 2021
Completion date November 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT04761510 - Mindfulness-SOS: Stress Reduction for Refugees N/A
Completed NCT03722095 - Research on the Effects of Combined Neurostimulation Protocols on Stress N/A
Completed NCT02972203 - MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home N/A
Completed NCT06155162 - The HuggyPuppy Intervention for War-related Distress N/A
Not yet recruiting NCT05081830 - Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders N/A
Completed NCT04380259 - Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) Phase 1/Phase 2
Recruiting NCT05425511 - WELL-being Improvement Following a SOphrology Intervention in Hospital Staff N/A
Completed NCT04611399 - MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support N/A
Recruiting NCT06016530 - Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study N/A
Recruiting NCT05466851 - An Exploratory Study Examining Biopsychosocial Markers of Anxiety and Depression
Recruiting NCT03623555 - Applied Social Neuroscience: the Building Resilience Among Women Project
Enrolling by invitation NCT04396600 - The Professional Peer Resilience Initiative
Completed NCT03308630 - Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents N/A
Terminated NCT03609450 - Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3) N/A
Terminated NCT04268355 - MINDFUL-PC for Portuguese Speakers Pilot Study 2020 N/A
Recruiting NCT05874856 - Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders
Completed NCT04278586 - Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase) N/A
Completed NCT03265600 - Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2) N/A
Recruiting NCT05616286 - Mindfulness-SOS for Refugees N/A
Completed NCT03798431 - MINDFUL-OBOT: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment N/A