The Effect of Nursing Counseling Based on Neuman Systems Model on Perceived Stress, Coping With Stress and Birth Outcomes Among Pregnant Women at High Risk of Pre-term Labor
Phase: NA
Conditions: Preterm Birth
Sponsor: Erzurum Technical University

The Effect of Nursing Counseling Perceived Stress, Coping and Birth Outcomes Among 
Pregnant Women 
 
 
Study Protocol  
Before commencing the study, approval from the ethics committee was obtained, from the 
Ondokuz Mayıs University Medical Practices Ethics Committee (see Appendix 1), and research 
permission was granted by OMUSUVAM (see Appendix 2). Pregnant women at risk of preterm 
birth were enrolled in the study after obtaining both written and verbal consent from them (see  
Appendix 3-4). It was emphasized that they were free to withdraw from the research at any time 
of their choosing. 
 
 
Statistical Analysis Plan 
Data analyses were performed via the SAS (Statistical Analysis System Institute, Cary, North 
Caroline) 9.4 Program. Scale data, including mean and standard deviations, were computed for 
both the experimental and control groups. Here, a focus was given to the dependent variables 
considered. A t-test was performed to examine the significance of the differences between the 
two groups in terms of the dependent variables held. A comparison of the pre-test, interim 
follow-up and post-test measurements for the participants in both the experimental and control 
groups, as based on the dimension of time, was carried out using repeated measures analysis of 
variance. Mean and standard deviation from descriptive statistics were used for the variables of 
the study determined by measurement, and number and percentage were used for the variables 
determined by counting. In pairwise comparisons between variables with two categories, t-test 
between independent groups was applied, and Analysis of Variance (F test) was applied to find 
differences between variables with three or more categories. In evaluating the pre-test, interim 
follow-up and post-test findings of the experimental and control groups; To compare the 
measurements taken from the same pregnant women at different follow-ups, interdependent 
groups or paired observation t-test was used, and Chi-Square analysis was used to reveal the 
relationship between the variables answered as open-ended questions in the findings determined 
by the measurement. One-way Repeated Measurement Variance Analysis was used in the 
analysis of more than one variable taken from the same pregnant women. Cronbach Alpha 
coefficient was used to calculate the reliability coefficients of the scale and its sub-dimensions. 
The value of 0.05 was accepted as the significance level throughout the study. 

Appendix 1 Ethics Committee Approval 
 
 
 
 
 

Appendix 2 Hospital (OMU SUVAM) research permission certificate 
 
 
 
 
 
 
 
 
 
 
 
 

Appendix 3 Informed voluntary consent form (Experimental Group) 
Hello, my name is XXX. I am a lecturer at Ondokuz Mayıs University, Faculty of Health 
Sciences, and a doctoral student in the Department of Nursing. Ondokuz Mayıs University, 
Faculty of Health Sciences, Department of Nursing, Lecturer Prof. Dr. I am conducting my 
thesis research titled "The Effect of Nursing Counseling Based on Neuman Systems Model on 
Perceived Stress, Coping with Stress and Birth Outcomes in Pregnant Women at Risk of 
Preterm Labor" under the supervision of YYY. 
          The aim of this study is to determine the effect of education and counseling offered to 
pregnant women at risk of premature birth on stress perception, coping with stress and 
pregnancy outcomes. In line with the results of this research, it aims to ensure continuity in 
providing education and counseling to pregnant women at risk of premature birth. Within the 
scope of the research, you will be provided with counseling through the phone number and 
counseling unit you can reach as long as you need until birth. Additionally, training will be 
provided under four headings, once a week for 40-60 minutes (simultaneously with your control 
day as much as possible). Some scales will be applied at the program's beginning, mid-term and 
end. Everything you say during the counseling process will remain confidential. Your name 
and personal information will be used solely for research purposes and will never be disclosed 
to others. The first interview and the last interview (including your opinions about the 
consultancy unit) will be recorded and with your permission. If you do not want to continue the 
research, you can leave at any time. Your data may be used for publication purposes without 
disclosing your name. Participation in the research is entirely voluntary. Reading and approving 
this form will mean that you agree to participate in the research. 
Consent to Participate in the Study 
I have read all the explanations in the Informed Volunteer Consent Form. Written and verbal 
explanations about the research whose subject and purpose are stated above were made to me 
by the researcher named below. I had the opportunity to ask questions and discuss and received 
satisfactory answers. I know that I can quit this study whenever I want, without having to give 
any reason, and that I will not face any negative consequences if I quit. I agree to participate in 
this research voluntarily, without any pressure or coercion. 
History: 
Participant: 
Signature 
Researcher: 
XXX 
Signature: 
 
 
 
 
 
 

Appendix 4 Informed voluntary consent form (Control Group) 
Hello, my name is XXX. I am a lecturer at Ondokuz Mayıs University, Faculty of Health 
Sciences, and also a doctoral student in the Department of Nursing. Ondokuz Mayıs University, 
Faculty of Health Sciences, Department of Nursing, Lecturer Prof. Dr. I am conducting my 
thesis research titled "The Effect of Nursing Counseling Based on Neuman Systems Model on 
Perceived Stress, Coping with Stress and Birth Outcomes in Pregnant Women at Risk of 
Preterm Labor" under the supervision of YYY. 
          This study aims to determine the effect of education and counseling offered to pregnant 
women at risk of premature birth on stress perception, coping with stress and pregnancy 
outcomes. In line with the results of this research, it is aimed to provide education and 
counseling to pregnant women at risk of premature birth. The research will be conducted 
through a survey of approximately 10-15 minutes. The surveys will be administered 3 times in 
total until birth. If you do not want to continue the research, you can leave at any time. 
Everything you say during the interview will remain confidential. Your name and personal 
information will be used solely for research purposes and will never be disclosed to others. 
Your data may be used for publication purposes without disclosing your name. Participation in 
the research is entirely voluntary. Reading and approving this form will mean that you agree to 
participate in the research. 
Consent to Participate in the Study 
I have read all the explanations in the Informed Volunteer Consent Form. Written and verbal 
explanations about the research whose subject and purpose are stated above were made to me 
by the researcher named below. I had the opportunity to ask questions and discuss and received 
satisfactory answers. I know that I can quit this study whenever I want, without having to give 
any reason, and that I will not face any negative consequences if I quit. The research in question 
is carried out on its own, without any pressure or coercion. 
History: 
Participant: 
Signature 
Researcher: 
XXX 
Signature: