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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile application | Other | 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. |
| 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 | 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 |
| 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seher SARIKAYA KARABUDAK, Ass.Prof. | Aydin Adnan Menderes University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aydın Adnan Menderes University | Aydin | EFELER | 09100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28198966 | Background | 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. | |
| 27543152 | Background | 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. |
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Inclusion Criteria for the Study:Nurses' inclusion criteria for the study; Nurses who were actively working in the NICU, had an IOS or Android smartphone, and were active users were included in the study.
Exclusion Criteria for the Study:Nurses who had a Windows or Blackberry smartphone were not included in the study.
Exclusion Criteria for the Study:Nurses who could not complete all the steps of the study and who wanted to leave the study of their own volition were excluded from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. mobile application: 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Newborn nurse
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. mobile application: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 1 person left her job due to pregnancy | Posted | Median | Standard Deviation | units on a scale | Before starting the intervention |
|
3 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. mobile application: 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Canan Sümeyra GÜN | Kütahya Health Sciences University | 05458125720 | canansumeyra.gun@ksbu.edu.tr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 12, 2024 | Sep 23, 2025 | Prot_SAP_ICF_000.pdf |
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randomized controlled experimental study
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|
| 3 months |
| 31277478 | Background | 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. |
| 32427611 | Background | 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. |
| 17329732 | Background | 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. |
| 30299305 | Background | Bautista JR. Filipino Nurses' Use of Smartphones in Clinical Settings. Comput Inform Nurs. 2019 Feb;37(2):80-89. doi: 10.1097/CIN.0000000000000482. |
| 27697234 | Background | 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. |
| 30442294 | Background | 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. |
| 25265893 | Background | 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. |
| 29569380 | Background | 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. |
| 28752529 | Background | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Professional working time | Less than 1 year 1-5 years More than 5 years | Count of Participants | Participants |
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| OG000 | Mobile Application Group | In the study, before the mobile application , the overall score of the study group was 2.44±0.28, while the control group was 2.44±0.29. |
| OG001 | Control Group | In the study, before the mobile application , the overall score of the study group was 2.44±0.28, while the control group was 2.44±0.29. |
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| Primary | 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. | In the 1st month she stopped working due to pregnancy. | Posted | Mean | Standard Deviation | units on a scale | 1 Months |
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| Secondary | 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. | no casualties | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
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| System Usability Scale |
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| System Usability Scale-Turkish (SUS-TR) |
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