An interventional study of supportive care in Termination of Pregnancy, Supportive Care and Nursing Caries, sponsored by Eskisehir Osmangazi University. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-16.
Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Supportive care
This study was planned to evaluate the effectiveness of the navigation-assisted care program based on the Swanson Theory of Care, which was developed for women who underwent medical termination as a result of a complication caused by maternal or fetal reasons.
H1: Navigation-assisted care program based on Swanson care theory reduces perinatal grief levels of women.
H2: Navigation-assisted care program based on Swanson care theory reduces depression-anxiety-stress levels of women
H3: Navigation-assisted care program based on Swanson care theory positively affects women's coping and adjustment levels.
Independent variables: Sociodemographic characteristics such as age, marital status, educational status and the Navigation Assisted Care Program Based on Swanson Care Theory constitute the independent variables.
Dependent variables: Scores from Perinatal Grief Scale, Depression, Anxiety and Stress Scale, Coping and Adaptation Process Scale, discharge time, labor pain constitute the dependent variables.
Preparation of mobile application:
After the formation of the training content, expert opinions and the completion of the ethics committee process, the construction phase of the mobile application started. The mobile application was named "Pregnancy Loss Support Program". In order for the patients in the intervention group to log in to the mobile application, a user name and password were defined, and the user names and passwords defined during the installation of the mobile application were reported to them by the researcher. Before starting the patient interviews with the mobile application, trials were made and updates were made regarding the deficiencies. Continuous support was provided to people through the Messaging section, which offers instant messaging so that participants' questions can be answered. The questionnaires applied during the study were made available to the participants in the Survey section. In the video section, videos that will provide technical support for mobile application installation and use have been added. A symptom diary section was created in order for the participants to indicate the changes that occurred in them, and the participants were provided to report their symptoms from this section.
Applications to the control group In the control group, data collection forms and measurement tools will be applied after admission to the service. No application will be made other than the routine maintenance of the hospital. The routine care of the hospital applied to the control group within the scope of the research includes the information that should be given before, during and after the procedure that should be done depending on the medical intervention. In addition, there is no support program planned in the hospital and at discharge, and there is no follow-up after discharge. In studies evaluating the effectiveness of education in the literature, 6-8 weeks are considered appropriate for evaluation. For this reason, the first measurement will be made in the 6th week of the study. In addition, in terms of evaluating the effects of medical termination on the woman in the long term, a post-test will be applied at the 10th week.
Eskisehir Osmangazi University is the lead sponsor of 153 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
1., 2., 3. İnterview (in hospital) The patient will be educated. Measuring tools will be applied. (Personal Information Form- Coping and Adaptation Process Scale)( discharge: Perinatal Grief Scale, Depression Anxiety Stress Scale) The mobile application developed within the scope of post-termination support will be downloaded to the patient's phone. Informed consent form will be signed by the patient. Sharing problems, presenting solutions. Follow-up of the patient and strengthening and supporting in this process. 4., 5., 6. Interview at home (following the patient with mobile application and phone calls) 7\. and 8., Interview at home (following the patient with mobile application and phone calls) Measuring tools will be appliedPerinatal Grief Scale, Depression, Anxiety and Stress Scale, Coping and Adaptation Process Scale
Other: supportive care
In the control group, data collection forms will be applied at admission and discharge to the service. There will be no application other than the routine care of the hospital. The routine care of the hospital applied to the control group within the scope of the research includes the information that should be given before, during and after the procedure that should be done depending on the medical intervention. In addition, there is no support program planned in the hospital and at discharge, and there is no follow-up after discharge. 1. Interview at hospital Measuring tools will be applied Perinatal Grief Scale, Depression, Anxiety and Stress Scale, Coping and Adaptation Process Scale, Discharge time, labor pain. 2. and 3. Interview at home Measuring tools will be applied Perinatal Grief Scale, Depression, Anxiety and Stress Scale, Coping and Adaptation Process Scale
After Medical Termination Navigation Assisted Care Program admission to the service will be held in the form of three interviews in the clinic before and after termination. The planned training will be given in three sessions and a different training module will be applied in each meeting. After the patient is discharged, three sessions will be held remotely via telephone.
perinatal grief-1
Evaluation will be made using the scale. Change will be evaluated at the after termination(birth) using the Perinatal grief scale Changes in the age of the patients over time will be evaluated. It will increase-decrease over time. The scale does not have any cutoff points. As the scale score increases, the level of grief increases The termination process of the patients may vary. The perinatal grief scale is first administered in the hospital after termination.
Time frame: 2nd or 3rd days
perinatal grief-2
Evaluation will be made using the scale. Change will be evaluated at the 7th interview (at 6-8weeks) using the Perinatal grief scale Changes in the age of the patients over time will be evaluated. It will increase-decrease over time. The scale does not have any cutoff points. As the scale score increases, the level of grief increases
Time frame: 8th weeks
perinatal grief-3
Evaluation will be made using the scale. Change will be evaluated at the 8th interview (at 10-12weeks) using the Perinatal grief scale Changes in the age of the patients over time will be evaluated. It will increase-decrease over time. The scale does not have any cutoff points. As the scale score increases, the level of grief increases
Time frame: 12th weeks
depression-anxiety-stress-1
Change will be evaluated at the after termination(birth) using the Depression Anxiety Stress Scale-21. The depression anxiety stress scale is first interwiev in the hospital after termination. The patient is followed as long as he stays in the hospital.(avarage3-4 days) Depression anxiety stress level of the patients will be evaluated. Scale has certain cutoff points. Women's depression, anxiety and stress will be examined. Changes will be observed over time. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue. Depression Anxiety Stress (Respectively) NORMAL 0-4 0-3 0-7 MILD 5-6 4-5 8-9 MEDİUM LEVEL 7-10 6-7 10-12 HIGH LEVEL 11-13 8-9 13-16 VERY HIGH 4+ 10+ 17+
Time frame: 2nd or 3rd days
depression-anxiety-stress-2
Change will be evaluated at the 7th interview (at 6-8weeks using the Depression Anxiety Stress Scale-21. The depression anxiety stress scale is first interwiev in the hospital after termination. The patient is followed as long as he stays in the hospital.(avarage3-4 days) Depression anxiety stress level of the patients will be evaluated. Scale has certain cutoff points. Women's depression, anxiety and stress will be examined. Changes will be observed over time. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue. Depression Anxiety Stress (Respectively) NORMAL 0-4 0-3 0-7 MILD 5-6 4-5 8-9 MEDİUM LEVEL 7-10 6-7 10-12 HIGH LEVEL 11-13 8-9 13-16 VERY HIGH 4+ 10+ 17+
Time frame: 8th weeks
depression-anxiety-stress-3
Change will be evaluated at the 8th interview (at 10.-12weeks) using the Depression Anxiety Stress Scale-21. The depression anxiety stress scale is first interwiev in the hospital after termination. The patient is followed as long as she stays in the hospital.(avarage3-4 days) Depression anxiety stress level of the patients will be evaluated. Scale has certain cutoff points. Women's depression, anxiety and stress will be examined. Changes will be observed over time. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue. Depression Anxiety Stress (Respectively) NORMAL 0-4 0-3 0-7 MILD 5-6 4-5 8-9 MEDİUM LEVEL 7-10 6-7 10-12 HIGH LEVEL 11-13 8-9 13-16 VERY HIGH 4+ 10+ 17+
Time frame: 12th weeks
coping and adaptation-1
Evaluation will be made using the Coping and adaptation scale. Change will be evaluated in the hospital before termination(birth), using the Coping and Adaptation Process Scale The increase in the coping and adjustment levels of the patients will be evaluated. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue. The Coping and Adaptation process scale, on the other hand, is first applied in the hospital after the hospitalization of the patients.
Time frame: first day
coping and adaptation-2
Evaluation will be made using the scale. Coping and adaptation scale Change will be evaluated at the 7th interview (at 6-8weeks) using the Coping and Adaptation Process Scale The increase in the coping and adjustment levels of the patients will be evaluated. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue.
Time frame: 8th weeks
coping and adaptation-3
Evaluation will be made using the scale. Coping and adaptation scale Change will be evaluated at the 8th interview (at 10.-12weeks) using the Coping and Adaptation Process Scale The increase in the coping and adjustment levels of the patients will be evaluated. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue.
Time frame: 12th weeks
Labor Pain-1
Evaluation will be made using the VAS scale in hospital. The change in pain scores of the experimental group and the control group will be compared. 1-The latent phase covers the period until the 3-4 cm gap in labor occurs. The pain he feels during this time will be measured with a visual analog scale. This process can take up to 1 day on average.
Time frame: first day
Labor Pain-2
Evaluation will be made using the VAS scale in hospital. The change in pain scores of the experimental group and the control group will be compared. 2-Pain during the act (baby's exit) will be measured with the visual analog scale. This process can take up to 1 day on average.
Time frame: first day
Labor Pain-3
Evaluation will be made using the VAS scale in hospital. The change in pain scores of the experimental group and the control group will be compared. 3-The pain felt by the baby for the first two hours after the action occurs will be measured with the visual analog scale. This process can take up to 1 day on average.
Time frame: first day
discharge time
The length of stay in the hospital will be calculated. Time between hospitalization and discharge. (avarage3-4 days) The time spent in the hospital can last for 3-4 days on average.
Time frame: Avarage 3-4 days
quality of sleeping
Change will be evaluated at the 8th interview (at 10.-12weeks) using the VAS Scale. A high score from the scale indicates good sleep quality. There are no cutoff piont on the scale.
Time frame: 12th weeks
Plan to share: Undecided
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