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Skin AbnormalitiesNCT04934254

The NEWBORN SKIN ASSESSMENT ATTITUDE SCALE

An observational study of Skin Abnormalities and Newborn, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Attitude Scale
How many people
300 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Mar 2021to 30 Oct 2022
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The nurses who work in Newborn intensive care unit

Who may be able to join

  • ●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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hasan Kalyoncu University

    Gaziantep, Şahinbey, 27010

Other trials in Turkey (Türkiye)

About this study

Official title: DEVELOPMENT of the NEWBORN SKIN ASSESSMENT ATTITUDE SCALE for NURSES

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.

Read the detailed 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.

Being tested
Attitude Scale
Keywords
Newborn, Skin, Scale, Nurse, Construction
Medical subject headings
Skin Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attitude ScaleOther

    26-item related to scale will construct and apply to nurses for creating scale

Study groups in NCT04934254
Study groupRoleWhat they receive
Newborn NursesNot described
Receives: Other: Attitude Scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scale Development Process

    94 questions will prepare as "Nurse Opinion Determination Form for "Newborn Skin Attitude" and 16 newborn nurses' opinions will collect.

    Measured: 3 months

  2. 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

    Measured: 1 month

  3. Validity and reliability of scale

    After final agreement of scale items, it will apply to at least 300 nurses for construction and psychometric analysis

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2021
  2. Study start30 Mar 2021
  3. Primary completion20 Oct 2022
  4. Study completion30 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04934254
Sponsor's protocol ID
2021-031
Status last verified
Mar 2025
First submitted
14 Jun 2021
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Fernandes JD, Machado MC, Oliveira ZN. Children and newborn skin care and prevention. An Bras Dermatol. 2011 Jan-Feb;86(1):102-10. doi: 10.1590/s0365-05962011000100014. English, Portuguese.

    PubMed 21437530
  • Suddaby EC, Barnett S, Facteau L. Skin breakdown in acute care pediatrics. Pediatr Nurs. 2005 Mar-Apr;31(2):132-8, 148.

    PubMed 15934568
  • Murdoch V. Pressure care in the paediatric intensive care unit. Nurs Stand. 2002 Oct 23;17(6):71-4, 76.

    PubMed 12434752
  • 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.

    PubMed 30387232
  • 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.

    PubMed 25539671

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