- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05776615
The Effect of the Mobile Application Developed for the Care of Sick Newborns
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
EFELER
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Aydin, EFELER, Turkey (Türkiye), 09100
- Aydın Adnan Menderes University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nurses working actively in NICU,
- Active user nurses who have a smart phone with IOS or Android software.
Exclusion Criteria:
- Failed to complete all the steps of the research,
- Nurses who want to leave the research voluntarily
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile Application Group
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.
|
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.
|
|
No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
Time Frame: 1 Months
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. The Nursing Diagnoses Perception Scale 2. MissCare Nursing Care Questionnaire in the Neonatal Intensive Care Unit 3. System Usability Scale-Turkish (SUS-TR)
Time Frame: 3 months
|
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. |
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determining the usability of the questionnaire and scale supported mobile application
Time Frame: 3 months
|
Determining the usability of the questionnaire and scale supported mobile application
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3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Seher SARIKAYA KARABUDAK, Ass.Prof., Aydin Adnan Menderes University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- Bautista JR. Filipino Nurses' Use of Smartphones in Clinical Settings. Comput Inform Nurs. 2019 Feb;37(2):80-89. doi: 10.1097/CIN.0000000000000482.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HF-22003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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