NCT04934254

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

June 14, 2021

Last Update Submit

March 22, 2025

Conditions

Keywords

NewbornSkinScaleNurseConstruction

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Newborn Nurses

Other: Attitude Scale

Interventions

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

Newborn Nurses

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The nurses who work in Newborn intensive care unit

You may qualify if:

  • ●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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27010, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

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

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

    PMID: 12434752BACKGROUND
  • 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.

    PMID: 30387232BACKGROUND
  • 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.

    PMID: 25539671BACKGROUND

MeSH Terms

Conditions

Skin Abnormalities

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Güven Hoş

    Hasan Kalyoncu University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Res.Asst.

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 22, 2021

Study Start

March 30, 2021

Primary Completion

October 20, 2022

Study Completion

October 30, 2022

Last Updated

March 26, 2025

Record last verified: 2025-03

Locations