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
Phase: NA
Conditions: Nursing Caries, Newborn
Sponsor: Kutahya Health Sciences University

ID: HF-22003  
  
Title:The Effect of the Mobile Application Developed for the Care of Sick Newborns  
 
NCT Number: NCT05776615  
 
Document Date:  June  12, 2024  (IRB approval date) 

Development of Mobile Application 
Pre test 
Identification of nurses eligible for inclusion in the study 
Randomized 
Mobile aplication group (n= 31 ) 
Control grup (n=32 ) 
Informing nurses about mobile application and research, obtaining written consent from nurses 
 
 
 
 
 
 
Mobile Application group data collection 
Collection of Mobile Application Data: The nurses included in the 
study group filled out the data collection tools (Nurse Descriptive 
Characteristics form, nursing diagnoses perception scale, 
8MISSCARE nursing Determination Questionnaire in the Neonatal 
Intensive Care Unit) before the application was installed on their 
phones, the mobile application was introduced, the application was 
downloaded from Google Play Store or App Store, and how to use 
the application was explained. Nurses clicked the notifications from 
the mobile application. In addition, they were asked to prepare and 
record a care plan using the mobile application from a patient 
newborn that they care for every week. At the end of the 1st and 3rd 
months, Nursing Diagnosis Perception Scale, MISSCARE Nursing 
Questionnaire in the Neonatal Intensive Care Unit, and System 
Applicability Scale (SUS-TR) were administered to the nurses. 
ANALYSING THE DATA AND REPORTING THE RESEARCH 
Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collection of Control Group Data 
The nurses included in the control group 
were administered the Nurse Descriptive 
Characteristics form, nursing diagnoses 
perception scale, 8MISSCARE nursing 
Determination Questionnaire in the Neonatal 
Intensive Care Unit. At the end of the 1st and 
3rd months, the nursing diagnoses perception 
scale and the 8MISSCARE nursing 
Determination Questionnaire in the Neonatal 
Intensive Care Unit were applied to the 
nurses. System Applicability Scale (SUS- 
TR) was not applied. 

Statistical Analysis Plan 
Statistical analysis of the data was performed using SPSS (IBM SPSS Statistics 27) package 
programme. Frequency tables and descriptive statistics were used to interpret the findings of 
the study. The conformity of the measurements to normal distribution was analysed using 
Shapiro-Wilk analysis. Consistent with parametric methods, 8Independent sample t test9 was 
used to compare the measurements of two independent groups. The Repeated Measures (F-table 
value) method was used to compare the measurements of three or more dependent groups. 
8Bonferroni9 correction was applied for pairwise comparisons of three or more groups. 
Nonparametric methods were used for measurements that did not fit the normal distribution. 
Consistent with nonparametric methods, the 8Mann-Whitney U9 test (Z-table value) was used 
to compare the measurements of two independent groups. The Wilcoxon signed-rank test (Z- 
table value) was used to compare the measurements of two dependent groups. 8Friedman9 test 
(χ2-table value) was used to compare the measurements of three or more dependent groups. 
8Bonferroni9 correction was applied for pairwise comparisons of three or more groups. The 
relationship between two qualitative variables was analysed by Pearson-χ2 cross-tabulations. 
Spearman's correlation coefficient was used to examine the relationship between two 
quantitative variables that were not normally distributed. Biostatistics expert support was 
obtained in the analysis of the data. 

This  document  has  been  signed  with  a  secure  electronic  signature.
June  24,  2024
Non-Interventional  Research  Ethics  Committee
AYDIN  ADNAN  MENDERES  UNIVERSITY  RECTORATE
Turkish  Republic
Number:  E-21347915-050.04-549014  
Subject:  Regarding  your  Ethics  Committee  Application  
No.  2022/021.
Associate  Professor  Dr.  Seher  SARIKAYA  KARABUDAK
Protocol  No:  2022/021
The  petition  of  Assoc.  Prof.  Dr.  Seher  SARIKAYA  KARABUDAK ,  regarding  the  final  report  of  her  research  titled  "The  Effect  
of  the  Mobile  Application  Developed  for  the  Care  of  Sick  Newborns  on  Nurses'  Perception  of  Nursing  Diagnoses  and  Unmet  Care:  A  
Randomized  Controlled  Experimental  Study",  which  was  approved  by  the  Non-Interventional  Research  Ethics  Committee  of  Aydÿn  
Adnan  Menderes  University  Health  Sciences  Institute  on  10.06.2022,  was  discussed  on  12.06.2024 .
Below  is  the  decision  number  I  regarding  your  study  taken  at  the  regular  meeting  of  the  Health  Sciences  Institute  Non-
Interventional  Research  Ethics  Committee  held  on  June  12,  2024.  I  present  it  for  your  information.
Responsible  Executive:  Assoc.  Prof.  Dr.  Seher  SARIKAYA  KARABUDAK
The  petition  stated  that  the  study  had  been  completed,  and  the  final  report  was  attached.  It  was  concluded  that  the  study  
had  been  conducted  and  completed  within  ethical  guidelines,  and  that  the  requested  documents  were  complete.  It  was  unanimously  
decided  that  the  study  should  receive  Ethics  Committee  Approval .
Chairman  of  the  Board
Directorate  of  the  Institute  of  Health  Sciences
Faculty  Member
DECISION:  I
Prof.  Dr.  Turhan  DOST
ADÜ  Document  Date  and  Number:  24.06.2024  -  549014
e-Mail:  saglikbilimleri@adu.edu.tr  Internet  Address:  akademik.adu.edu.tr/enstitu/saglik/  KEP  Address:  
adnanmenderesuniversitesi@hs01.kep.tr
Verification  Code:  BSRA1LTPE9  Central  
Campus  Institutes  Building  Efeler/AYDIN
This  document  has  been  signed  with  a  secure  electronic  signature.
Phone:  0(256)  214  47  45  Fax:  0(256)  220  26  14
For  information:  Duygu  YEÿÿLFÿDAN
Reporter
Verification  Address:  https://turkiye.gov.tr/ebd?eK=5740&eD=BSRA1LTPE9&eS=549014
Machine Translated by Google

FORM 4 
INFORMED CONSENT FORM  
(Control Group) 
The study titled “The Effect of the Mobile Application Developed for the Care of 
Hospitalized Newborns on Nurses’ Perception of Nursing Diagnoses and Miss Care: A 
Randomized Controlled Experimental Study” will be conducted by Assoc. Prof. Dr. Seher 
SARIKAYA KARABUDAK and Lecturer Canan Sümeyra GÜN. 
 
This randomized controlled experimental study has been designed to determine the effect 
of the mobile application developed for the care of hospitalized newborns in the Neonatal 
Intensive Care Unit (NICU) on nurses’ perceptions of nursing diagnoses and unmet care, as 
well as to evaluate the usability of the mobile application. Participation in this study is 
voluntary. You may choose not to participate or may withdraw while filling out the 
questionnaires. Data collected through the questionnaires will be used for scientific 
purposes only. No adverse effects are expected from participating in this study. 
 
During the study, you will be asked to complete the following: 
- Nurse Descriptive Characteristics Form (19 items, including age, gender, work 
experience, etc.), 
- Nursing Diagnoses Perception Scale (26 items), 
- NICU “Unmet Nursing Care” Questionnaire (69 items). 
 
Completing these forms will take approximately 20–30 minutes. Afterwards, at the end of 
the 1st month and at the end of the 3rd month, you will again be asked to complete the 
Nursing Diagnoses Perception Scale (26 items) and the NICU “Unmet Nursing Care” 
Questionnaire (69 items). 
 
All questions related to the study will be answered by the researchers, Assoc. Prof. Dr. 
Seher SARIKAYA KARABUDAK and Lecturer Canan Sümeyra GÜN. At the end of the 
study, if you wish, the mobile application can also be installed on your device for your use. 
 
For any questions related to this study, you may contact: 
- Assoc. Prof. Dr. Seher SARIKAYA KARABUDAK at 0505 448 37 03 or 
ssarikaya@adu.edu.tr 
- Lecturer Canan Sümeyra GÜN at 0545 812 57 20 or canansumeyra.gun@ksbu.edu.tr 
 
You may ask during or after the application, either via e-mail or by phone (mobile). 
 
We thank you for your participation. 
 
 
 
 
I, the undersigned, agree to participate in the study titled “The Effect of the Mobile 
Application Developed for the Care of Hospitalized Newborns on Nurses’ Perception of 
Nursing Diagnoses and Unmet Care: A Randomized Controlled Experimental Study.” 
 
Assoc. Prof. Dr. Seher SARIKAYA KARABUDAK and Lecturer Canan Sümeyra GÜN have 

FORM 4 
provided me with detailed verbal and/or written information about the structure, purpose, and 
possible duration of the study, what is expected from me, and what to do in case of an adverse 
situation. 
 
I have had the opportunity to ask all questions I had regarding the study to the researchers, and 
I understood the answers and the information provided to me. I permit Assoc. Prof. Dr. Seher 
SARIKAYA KARABUDAK and Lecturer Canan Sümeyra GÜN to conduct this study with 
me, under the condition that they explain the details clearly and maintain the confidentiality of 
my 
personal 
information. 
 
I agree to comply with all the rules throughout the study, to fully cooperate with the researchers, 
and to contact them immediately if any issue arises. I accept that the results of this study may 
be used without restriction in publications, reports, or other scientific documents. I also 
understand that I can withdraw from this study at any time 
 
Researcher 
Title, Name-Surname: Lecturer Canan 
Sümeyra Gün/Assoc. Prof. Dr. Seher 
SARIKAYA 
KARABUDAK 
Date: 
Phone No: 05458125729/0505 448 37 03 
Signature: 
 
Address: 
Aydın 
Adnan 
Menderes 
University, Central Campus, Faculty of 
Nursing, Aydın 09100 
 
Participant 
Name-Surname: 
Date: 
Phone No: 
Signature: 
Participant 
Name-Surname: 
Date: 
Phone No: 
Signature: 
 

FORM 4 
 
 INFORMED CONSENT FORM  
(Study Group) 
 
 The study titled “The Effect of the Mobile Application Developed for the Care of Hospitalized 
Newborns on Nurses’ Perception of Nursing Diagnoses and Miss Care: A Randomized Controlled 
Experimental Study” will be conducted by Assoc. Prof. Dr. Seher SARIKAYA KARABUDAK and 
Lecturer Canan Sümeyra GÜN. This randomized controlled experimental study has been designed to 
determine the effect of the mobile application developed for the care of hospitalized newborns in the 
Neonatal Intensive Care Unit (NICU) on nurses’ perceptions of nursing diagnoses and miss care, as 
well as to evaluate the usability of the mobile application. Participation in this study is voluntary. 
You may choose not to participate or may withdraw while filling out the questionnaires. Data 
collected through the questionnaires will be used only for scientific purposes. No adverse effects are 
expected from participating in this study. During the study, you will be asked to complete: - Nurse 
Descriptive Characteristics Form (19 items, such as age, gender, work experience, etc.), - Nursing 
Diagnoses Perception Scale (26 items), - NICU “MISSCARE” Questionnaire (69 items). Completing 
these forms will take approximately 30–40 minutes. Afterwards, the mobile application developed 
for the care of hospitalized newborns will be installed on your phone. You will be provided with a 
username and password to log in, its functionality will be checked, and you will be informed about 
its use. During the usage period, you will receive periodic notifications via the mobile application, 
and you will need to respond by selecting “Yes” or “No.” Paying attention to these notifications is 
important and valuable for the effectiveness of the study. In addition, it is your legal responsibility 
not to share the mobile application and its content with other nurses. Maintaining this confidentiality 
during the study is essential for the reliability and accuracy of the results. We kindly ask for your 
diligence regarding this matter. At the end of the study, this mobile application will also be installed 
for other nurses upon their request. All questions related to the study and the mobile application will 
be answered by the researchers, Assoc. Prof. Dr. Seher SARIKAYA KARABUDAK and Lecturer 
Canan Sümeyra GÜN.  
At the end of the 1st month and at the end of the 3rd month after you start using the mobile 
application, you will again be asked to complete the Nursing Diagnoses Perception Scale (26 items), 
the NICU “MISSCARE” Questionnaire (69 items), and the System Usability Scale (10 items). For 
any questions related to this research, you may contact: - Assoc. Prof. Dr. Seher SARIKAYA 
KARABUDAK at 0505 448 37 03 or ssarikaya@adu.edu.tr - Lecturer Canan Sümeyra GÜN at 0545 
812 57 20 or canansumeyra.gun@ksbu.edu.tr You may ask during or after the application, either via 
e-mail or by mobile phone. We thank you for your participation. 
 
 
I, the undersigned, agree to participate in the study titled “The Effect of the Mobile Application 
Developed for the Care of Hospitalized Newborns on Nurses’ Perception of Nursing Diagnoses and 
Miss Care: A Randomized Controlled Experimental Study.” Assoc. Prof. Dr. Seher SARIKAYA 
KARABUDAK and Lecturer Canan Sümeyra GÜN have provided me with detailed verbal and/or 
written information about the structure, purpose, and possible duration of the study, what is expected 
from me, and what to do in case of an adverse situation. I have had the opportunity to ask all questions 
I had regarding the study to the researchers, and I understood the answers and the information provided 
to me. I permit Assoc. Prof. Dr. Seher SARIKAYA KARABUDAK and Lecturer Canan Sümeyra GÜN 
to conduct this study with me, under the condition that they explain the details clearly and maintain the 
confidentiality of my personal information. Throughout the study, I pledge not to share the username, 
password, or application content provided to me with anyone else. I also agree to comply with all the 

FORM 4 
rules, to fully cooperate with the researchers, and to contact them immediately if any issue arises. I 
accept that the results of this study may be used without restriction in publications, reports, or other 
scientific documents. I also understand that I can withdraw from this study at any time. 
 
Researcher 
Title, Name-Surname: Lecturer Canan 
Sümeyra Gün/Assoc. Prof. Dr. Seher 
SARIKAYA 
KARABUDAK 
Date: 
Phone No: 05458125729/0505 448 37 03 
Signature: 
 
Address: 
Aydın 
Adnan 
Menderes 
University, Central Campus, Faculty of 
Nursing, Aydın 09100 
 
 
 
 
 
Participant Name-Surname: 
 Date:  
Phone No:  
Signature: