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Nursing CariesNCT05776615

The Effect of the Mobile Application Developed for the Care of Sick Newborns

A study testing mobile application in people with Nursing Caries and Newborn, run by Kutahya Health Sciences 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 goal of this randomize controlled trial determine the effect of the mobile application developed for the care of sick newborns in the Neonatal Intensive Care Unit on nurses' perception of nursing diagnoses and care that cannot be met, and to measure the usability of the mobile application. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Nursing Caries, Newborn
What is being tested?
mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Jul 2023to 12 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Nurses working actively in NICU,
  • Active user nurses who have a smart phone with IOS or Android software.

Who cannot join

  • Failed to complete all the steps of the research,
  • Nurses who want to leave the research voluntarily

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Aydın Adnan Menderes University

    Aydin, EFELER, 09100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of the Mobile Application Developed for the Care of Sick Newborns on Nurses' Perception of Nursing Diagnoses and MissCare: A Randomized Controlled Trial

The goal of this randomize controlled trial determine the effect of the mobile application developed for the care of sick newborns in the Neonatal Intensive Care Unit on nurses' perception of nursing diagnoses and care that cannot be met, and to measure the usability of the mobile application. The main questions it aims to answer are; Does the mobile application developed for the care provided in the neonatal intensive care unit have an effect on the perception of nursing diagnoses? Does the mobile application developed for care provided in the neonatal intensive care unit have an impact on "missed nursing care? Participants will be used for 3 months from the developed mobile application. The control group will continue routine nursing care.

Researchers will compare the perception of nursing diagnosis and unaffordable nursing care survey at the end of month 1 and month 3. Additionally, the usability of the mobile application will be evaluated by applying the system applicability scale to the experimental group.

Read the detailed description

Mobile application has become an important and necessary element in nursing education and clinical nursing practices, and its use has gradually increased. Neonatal intensive care units (NICUs) are areas where complex and quality health care is provided for newborns. The development of the nursing process, especially in the neonatal intensive care unit, may shorten the duration of the care that should be provided to newborns. New ways such as mobile applications can be sought to assist in the realization of the nursing process and to strengthen the diagnostic perception of neonatal nurses. This study is a randomized controlled experimental study designed to determine the effect of the mobile application developed for the care of sick newborns in the Neonatal Intensive Care Unit on nurses' perception of nursing diagnoses and care that cannot be met, and to measure the usability of the mobile application. A total of 69 nurses working in the neonatal intensive care unit in turkey will constitute the universe of the research. In this study, participants will be selected for experimental and control groups using a stratified random sampling method (the stratification criteria will be based on the institutions where the nurses work). The sample will be calculated as experimental group: 27 control group: 27 in total. Samples from the identified will be selected using the random numbers table.

In this study, Nurse Descriptive Characteristics Form; Nursing Diagnosis Perception Scale ; Questionnaire for Determining "missed nursing care" in the Neonatal Intensive Care Unit created by the researcher ; System Usability Scale will be used. For the missed nursing care nursing care determination questionnaire, expert opinion was taken and applied to the pilot group, and its content validity was checked.

Being tested
mobile application
Keywords
Newborn, Misscare, Nursing Process, Mobile Application

What participants receive

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

  • mobile applicationOther

    In the collection of Mobile Application group data, they will be asked to fill out the forms.The mobile application will be introduced, the application will be downloaded from the virtual market (Google Play Store or App Store) to the phone, login will be provided by giving a user name and password, and how to use the application will be explained. Participants will be asked to provide nursing care using this application once a week for 3 months.Nursing Diagnosis Perception Scale with nurses at the end of the 1st month and at the end of the 3rd month; " MıssCare" Questionnaire in the Neonatal Intensive Care Unit(NICU); System Availability Scale will be applied.

Study groups in NCT05776615
Study groupRoleWhat they receive
Mobile Application GroupExperimentalIn the collection of Mobile Application data, they will be asked to fill out the forms.The mobile application will be introduced, the application will be downloaded from the virtual market (Google Play Store or App Store) to the phone, login will be provided by giving a user name and password, and how to use the application will be explained. Participants will be asked to provide nursing care using this application once a week for 3 months. Nursing Diagnosis Perception Scale with nurses at the end of the 1st month and at the end of the 3rd month; " MıssCare" Detection Questionnaire in the Neonatal Intensive Care Unit; System Availability Scale will be applied.
Receives: Other: mobile application
Control groupNo interventionParticipants included in the control group, Nurse Descriptive Characteristics form; Nursing Diagnoses Perception Scale, "Missing Nursing Care" Detection Questionnaire will be applied in the Neonatal Intensive Care Unit. Nursing Diagnoses Perception Scale at the end of the 1st month and at the end of the 3rd month; The "Missing Nursing Care" Identification Questionnaire will be applied again in the Neonatal Intensive Care Unit, and the System Usability Scale will not be applied to the control group.

What is being measured

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

  1. Pre-test The Nurse Descriptive Characteristics Form; The Nursing Diagnoses Perception Scale; MissCare Nursing Care Questionnaire in the Neonatal Intensive Care Unit

    Nurse Descriptive Characteristics Form: A 19-item questionnaire (18 closed, 1 open-ended) developed from the literature to collect demographic and professional information including education, experience, NICU background, work schedule, caregiving practices, nursing process use, and mobile app use. Scoring: Descriptive only.

    Nursing Diagnosis Perception Scale: A 20-item, 5-point Likert scale (1 = Strongly agree, 5 = Strongly disagree) assessing four subscales-Professional definition, Clarity, Ease of use, Conceptual dimension. Score range: 1-5 (mean). Lower scores indicate more positive perceptions.

    MissCare Nursing Care Questionnaire in the NICU: A 69-item, 4-point Likert tool (1 = Always performed, 4 = Never performed) evaluating missed care in ten domains; lower scores reflect more complete care.

    Measured: Before starting the intervention

  2. 1. The Nursing Diagnoses Perception Scale 2. MissCare Nursing Care Questionnaire in the Neonatal Intensive Care Unit 3. System Usability Scale-Turkish (SUS-TR)

    Nursing Diagnosis Perception Scale: A 20-item, 5-point Likert scale (1 = Strongly agree, 5 = Strongly disagree) assessing four subscales-Professional definition, Clarity, Ease of use, Conceptual dimension. Score range: 1-5 (mean). Lower scores indicate more positive perceptions.

    MissCare Nursing Care Questionnaire in the NICU: A 69-item, 4-point Likert tool (1 = Always performed, 4 = Never performed) evaluating missed care in ten domains; lower scores reflect more complete care.

    System Usability Scale-Turkish (SUS-TR) is a brief scale developed to measure user views on system usability. Scores are calculated on a 0-100 scale, with higher scores indicating better usability. "This scale was applied exclusively to the Mobile Application Group.

    Measured: 1 Months

Secondary outcomes (1)
  1. 1. The Nursing Diagnoses Perception Scale 2. MissCare Nursing Care Questionnaire in the Neonatal Intensive Care Unit 3. System Usability Scale-Turkish (SUS-TR)

    Nursing Diagnosis Perception Scale: A 20-item, 5-point Likert scale (1 = Strongly agree, 5 = Strongly disagree) assessing four subscales-Professional definition, Clarity, Ease of use, Conceptual dimension. Score range: 1-5 (mean). Lower scores indicate more positive perceptions.

    MissCare Nursing Care Questionnaire in the NICU: A 69-item, 4-point Likert tool (1 = Always performed, 4 = Never performed) evaluating missed care in ten domains; lower scores reflect more complete care.

    System Usability Scale-Turkish (SUS-TR) is a brief scale developed to measure user views on system usability. Scores are calculated on a 0-100 scale, with higher scores indicating better usability. "This scale was applied exclusively to the Mobile Application Group.

    Measured: 3 months

Timeline

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

  1. First posted20 Mar 2023
  2. Study start24 Jul 2023
  3. Primary completion24 Aug 2023
  4. Study completion12 Jun 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Model description
randomized controlled experimental study
Masking
Single blind
Who is masked
Care provider
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05776615
Sponsor's protocol ID
HF-22003
Status last verified
Jan 2026
First submitted
15 Feb 2023
Last updated
23 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Almeida SR, Sasso GT, Barra DC. Computerized nursing process in the Intensive Care Unit: ergonomics and usability. Rev Esc Enferm USP. 2016 Nov-Dec;50(6):998-1004. doi: 10.1590/S0080-623420160000700017. English, Portuguese.

    PubMed 28198966
  • Amoakoh-Coleman M, Borgstein AB, Sondaal SF, Grobbee DE, Miltenburg AS, Verwijs M, Ansah EK, Browne JL, Klipstein-Grobusch K. Effectiveness of mHealth Interventions Targeting Health Care Workers to Improve Pregnancy Outcomes in Low- and Middle-Income Countries: A Systematic Review. J Med Internet Res. 2016 Aug 19;18(8):e226. doi: 10.2196/jmir.5533.

    PubMed 27543152
  • Asif M, Jameel A, Hussain A, Hwang J, Sahito N. Linking Transformational Leadership with Nurse-Assessed Adverse Patient Outcomes and the Quality of Care: Assessing the Role of Job Satisfaction and Structural Empowerment. Int J Environ Res Public Health. 2019 Jul 4;16(13):2381. doi: 10.3390/ijerph16132381.

    PubMed 31277478
  • Baccin CRA, Dal Sasso GTM, Paixao CA, de Sousa PAF. Mobile Application as a Learning Aid for Nurses and Nursing Students to Identify and Care for Stroke Patients: Pretest and Posttest Results. Comput Inform Nurs. 2020 Jul;38(7):358-366. doi: 10.1097/CIN.0000000000000623.

    PubMed 32427611
  • Basch E, Artz D, Iasonos A, Speakman J, Shannon K, Lin K, Pun C, Yong H, Fearn P, Barz A, Scher HI, McCabe M, Schrag D. Evaluation of an online platform for cancer patient self-reporting of chemotherapy toxicities. J Am Med Inform Assoc. 2007 May-Jun;14(3):264-8. doi: 10.1197/jamia.M2177. Epub 2007 Feb 28.

    PubMed 17329732
  • Bautista JR. Filipino Nurses' Use of Smartphones in Clinical Settings. Comput Inform Nurs. 2019 Feb;37(2):80-89. doi: 10.1097/CIN.0000000000000482.

    PubMed 30299305
  • Bautista JR, Lin TT. Sociotechnical analysis of nurses' use of personal mobile phones at work. Int J Med Inform. 2016 Nov;95:71-80. doi: 10.1016/j.ijmedinf.2016.09.002. Epub 2016 Sep 16.

    PubMed 27697234
  • Bhatheja S, Fuster V, Chamaria S, Kakkar S, Zlatopolsky R, Rogers J, Otobo E, Atreja A, Sharma SK, Kini AS. Developing a Mobile Application for Global Cardiovascular Education. J Am Coll Cardiol. 2018 Nov 13;72(20):2518-2527. doi: 10.1016/j.jacc.2018.08.2183.

    PubMed 30442294
  • Blackman I, Henderson J, Willis E, Hamilton P, Toffoli L, Verrall C, Abery E, Harvey C. Factors influencing why nursing care is missed. J Clin Nurs. 2015 Jan;24(1-2):47-56. doi: 10.1111/jocn.12688. Epub 2014 Sep 30.

    PubMed 25265893
  • Blackman I, Lye CY, Darmawan IGN, Henderson J, Giles T, Willis E, Toffoli L, Xiao L, Verrall C. Modeling Missed Care: Implications for Evidence-Based Practice. Worldviews Evid Based Nurs. 2018 Jun;15(3):178-188. doi: 10.1111/wvn.12285. Epub 2018 Mar 23.

    PubMed 29569380
  • Blackman I, Papastavrou E, Palese A, Vryonides S, Henderson J, Willis E. Predicting variations to missed nursing care: A three-nation comparison. J Nurs Manag. 2018 Jan;26(1):33-41. doi: 10.1111/jonm.12514. Epub 2017 Jul 27.

    PubMed 28752529

Questions about this trial

What is this clinical trial studying?

A study testing mobile application in people with Nursing Caries and Newborn, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-test The Nurse Descriptive Characteristics Form; The Nursing Diagnoses Perception Scale; MissCare Nursing Care Questionnaire in the Neonatal Intensive Care Unit (time frame: Before starting the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05776615, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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