NCT05776615

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 23, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

February 15, 2023

Results QC Date

February 11, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

NewbornMisscareNursing ProcessMobile Application

Outcome Measures

Primary Outcomes (2)

  • 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.

    Before starting the intervention

  • 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.

    1 Months

Secondary Outcomes (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)

    3 months

Study Arms (2)

Mobile Application Group

EXPERIMENTAL

In 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.

Other: mobile application

Control group

NO INTERVENTION

Participants 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.

Interventions

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.

Mobile Application Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, EFELER, 09100, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    PMID: 28198966BACKGROUND
  • 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.

    PMID: 27543152BACKGROUND
  • 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.

    PMID: 31277478BACKGROUND
  • 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.

    PMID: 32427611BACKGROUND
  • 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.

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

    PMID: 30299305BACKGROUND
  • 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.

    PMID: 27697234BACKGROUND
  • 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.

    PMID: 30442294BACKGROUND
  • 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.

    PMID: 25265893BACKGROUND
  • 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.

    PMID: 29569380BACKGROUND
  • 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.

    PMID: 28752529BACKGROUND

Limitations and Caveats

This study included nurses with smartphones running Android or iOS. The collection of personal information (name and surname) may have influenced their responses, and nurses might have provided biased answers due to concerns about their image with managers. Additionally, the simultaneous presence of both study and control group nurses in the clinic may have led to information sharing between the groups.

Results Point of Contact

Title
Canan Sümeyra GÜN
Organization
Kütahya Health Sciences University

Study Officials

  • Seher SARIKAYA KARABUDAK, Ass.Prof.

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 20, 2023

Study Start

July 24, 2023

Primary Completion

August 24, 2023

Study Completion

June 12, 2024

Last Updated

January 23, 2026

Results First Posted

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations