Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04934254
Other study ID # 2021-031
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 30, 2021
Est. completion date July 20, 2022

Study information

Verified date November 2021
Source Hasan Kalyoncu University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The protection of the body integrity of the newborn is very important in terms of the development of physical and mental health and social health. Failure to protect the skin integrity of newborns and not paying attention to the clinical findings on the skin may cause morbidity/mortality. Attitudes of nurses can affect the evaluation of newborn skin negatively and/or positively. It was determined as the development of an attitude scale for newborn nurses to evaluate newborn skin and examining the factors affecting their attitudes. In line with this purpose, an attitude scale for newborn nurses regarding the evaluation of newborn skin will be developed and nurses' attitude levels, sociodemographic variables that are related to attitude and cause significant difference can be determined.


Description:

One of the indicators of the level of development of the countries is the newborn's life and death rates. The increase in the neonatal survival rate is primarily related to the care provided in the delivery room. Adaptation to the outside world is important because of the physiological and psychosocial changes experienced by the newborn after birth. For this reason, the adaptation process is monitored by monitoring the physiological and behavioral changes in the newborn. The skin is an important organ that "protects the organism against environmental factors and also regulates temperature and water loss in the organism". Newborn skin begins to act as a barrier in the womb, matures gradually, and continues for up to 1 year after birth. The immaturity of the skin of the newborn causes it to be the most open organ to external factors, and it has a very sensitive and fragile structure until it reaches the required maturity. Newborn skin can be damaged as a result of daily applications, and failure to follow up the skin regularly and unsuitable interventions for the skin cause morbidity/mortality. Differences in skin maturation of preterm infants vary according to gestational age. The stratum corneum, the outer layer of the epidermis, continues to mature until the 24th - 34th week of pregnancy. In preterm infants born before the stratum corneum is mature; Risks of infection, transepidermal water loss, temperature irregularity, absorption of topical agents, or physical trauma are encountered. In order for neonatal nurses to fulfill their duties and responsibilities; They should have knowledge and skills such as evaluating the newborn, using the equipment and technologies in the unit, training/counseling parents, communicating effectively and collaborating. While providing appropriate care by neonatal nurses increases the effect of the treatment, it also minimizes the side effects that may occur. It is also very important for the early diagnosis and treatment of the problems that have occurred and/or may occur with the clinical findings determined as a result of the skin evaluation of the newborn by the nurses. Attitude is one of the processes in which the individual is involved and has an important place in explaining the reason for the behavior of the individual. Attitude is a preparatory tendency for behavior and is the result of the interaction of emotion, thought and behavior elements. The fact that the individual has order, harmony and continuity between his feelings, thoughts and behaviors regarding a situation/event shows that a positive attitude towards that situation/event is developed. When the national and international literature on nurses, who have an important role in the evaluation of newborn skin, is examined, there are studies examining the knowledge and skills of skin evaluation and care of both healthy and risky newborns. However, nowadays, it is observed that instead of using an objective assessment tool, whose validity and reliability has been ensured, in the evaluation of the skin condition of especially healthy/risky newborns, the definitions of 'impaired skin integrity' or 'complete skin integrity' are still made with the evaluations made with a subjective approach, and the newborn skin is not considered as a whole. Regular evaluation of newborn skin is part of good care and allows for early diagnosis and treatment of skin problems. In the evaluations made with a subjective approach, the definitions of 'impaired skin integrity' or 'skin integrity' are made, and the skin is not considered as a whole. In the national and international literature review, assumptions and opinions regarding newborn nurses' evaluation of newborn skin with a subjective approach rather than an objective approach have been put forward, but no research has been encountered that examines their attitudes towards the subject. It is known that nurses' attitudes towards evaluating newborn skin are important for the early prevention of skin problems of newborns and other problems that may develop due to these problems, as an indicator of their tendencies towards the evaluation process.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date July 20, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: ?After obtaining written consent and informed consent form from neonatal nurses who agreed to participate in the study, they will be included in the study. Exclusion Criteria: - Written permission cannot be obtained, - Nurses who do not work with newborns, - Participants included in the sample in the development of the attitude scale will be excluded from the study in the final form application.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Attitude Scale
26-item related to scale will construct and apply to nurses for creating scale

Locations

Country Name City State
Turkey Hasan Kalyoncu University Gaziantep Sahinbey

Sponsors (1)

Lead Sponsor Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Djaja N, Youl P, Aitken J, Janda M. Evaluation of a skin self examination attitude scale using an item response theory model approach. Health Qual Life Outcomes. 2014 Dec 24;12:189. doi: 10.1186/s12955-014-0189-x. — View Citation

Fernandes JD, Machado MC, Oliveira ZN. Children and newborn skin care and prevention. An Bras Dermatol. 2011 Jan-Feb;86(1):102-10. Review. English, Portuguese. — View Citation

Murdoch V. Pressure care in the paediatric intensive care unit. Nurs Stand. 2002 Oct 23;17(6):71-4, 76. — View Citation

Rayner G, Blackburn J, Edward KL, Stephenson J, Ousey K. Emergency department nurse's attitudes towards patients who self-harm: A meta-analysis. Int J Ment Health Nurs. 2019 Feb;28(1):40-53. doi: 10.1111/inm.12550. Epub 2018 Nov 1. Review. — View Citation

Suddaby EC, Barnett S, Facteau L. Skin breakdown in acute care pediatrics. Pediatr Nurs. 2005 Mar-Apr;31(2):132-8, 148. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Scale Development Process 94 questions will prepare as "Nurse Opinion Determination Form for "Newborn Skin Attitude" and 16 newborn nurses' opinions will collect. 3 months
Primary Scale creation Measuring instrument consisting items will create. In order to determine the comprehensibility and content validity of the scale, it was presented to at least 20 experienced nurses 1 month
Primary Validity and reliability of scale After final agreement of scale items, it will apply to at least 300 nurses for construction and psychometric analysis 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT06350084 - Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection N/A
Not yet recruiting NCT04441463 - Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth (TryPla) N/A
Not yet recruiting NCT04337229 - Evaluation of Comfort Behavior Levels of Newborns With Artificial Intelligence Techniques N/A
Completed NCT01732978 - Are Parents Privileged Listeners Their Baby ? N/A
Unknown status NCT01029496 - Immediate VS Delayed Cord Clamping on Newborns Phase 1/Phase 2
Recruiting NCT06032494 - Investigating Changes in Vital Signs in Neonates
Completed NCT03690804 - Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units N/A
Completed NCT05064683 - The Effect of Facilitated Tucking and White Noise on Stress and Sleep of Newborns in Nasal CPAP N/A
Completed NCT04827849 - Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby N/A
Not yet recruiting NCT03630575 - Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study N/A
Recruiting NCT03109444 - Normative Radiographic Parameters and Growth Curve of Hips Less Than Six Weeks of Gestational Age Using Ultrasound
Not yet recruiting NCT06053931 - The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort N/A
Completed NCT04869176 - Effect of Caffeine on Heart Rate Variability in Newborns N/A
Not yet recruiting NCT05109481 - Masks and Visual Preferences in the Newborn
Completed NCT05103800 - Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive Interventions in Newborns N/A
Completed NCT03047967 - Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns N/A
Not yet recruiting NCT06418815 - Concept Map on Toxic Stress in Newborns N/A
Completed NCT03969459 - Impact of Exposure to Persistent Organic Pollutants During Pregnancy on the Composition of Breast Milk and Consequences on the Newborn
Completed NCT06352918 - Peripheral Central Catheter (PICC) Care N/A
Completed NCT05442619 - Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation During Venous Blood Collection N/A