Clinical trial NCT05326854: NAVIGATION ASSISTED CARE PROGRAM AND TERMINATION OF PREGNANCY
Official title: EVALUATION OF THE EFFECTIVENESS OF THE NAVIGATION ASSISTED CARE PROGRAM FOR WOMEN WITH MEDICAL TERMINATION
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Termination of Pregnancy
Supportive Care
Nursing Caries
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

* After the patient is admitted to the service at the first interview, data collection forms will be applied to the women. Afterwards, information will be given about the mobile application and its use, and the mobile application will be downloaded to the women's phones. The mobile application will be activated after the discharge of the patient, and the woman will be able to access the mobile application at discharge. The mobile application will be installed on the patient's phone at the first meeting in the hospital, and the patient will be informed about its use.
* In the second meeting, before the termination, the Medical Post-Termination Training and Supportive Care Program will continue.
* After the termination at the third meeting, the Medical Post-Termination Training and Supportive Care Program will continue. Telephone interviews and follow-up plans will be made with the patient after discharge. After the medical termination decision is taken, it is thought that there may be deficiencies during the training due to the high anxiety and stress levels of women, and the training program will be integrated into the mobile application so that women can access it at any time. In case of a problem with the use of the mobile application, women will be able to reach the researcher by phone during working hours and support will be provided by the researcher. In the study, it was planned to make home visits, but the follow-ups arising from the Coronavirus Pandemic process will be made in the form of telephone follow-up and follow-up. Survey and measurement tools will be applied.(Perinatal Grief Scale, Depression, Anxiety and Stress Scale, Coping and Adaptation Process Scale)
* After the discharge, the fourth interview will take place in the first week, the problems experienced by the patient will be discussed and his questions will be answered. Post-Medical Termination Education and Supportive Care Program will continue.
* After discharge, the fifth interview will be held in the second week and the problems experienced by the patient will be discussed.
* After discharge, the sixth interview will be held in the fourth week and the problems experienced by the patient will be discussed.
* The seventh interview will be held in the sixth week after discharge, during which the problems experienced by the patient will be discussed, data collection forms and measurement tools will be applied. (Perinatal Grief Scale, Depression, Anxiety and Stress Scale, Coping and Adaptation Process Scale)
* The eighth interview will be held in the tenth week, during which the problems experienced by the patient will be discussed, data collection forms and measurement tools will be applied. (Perinatal Grief Scale, Depression, Anxiety and Stress Scale, Coping and Adaptation Process Scale)

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.

• After the completion of the training and evaluation in terms of ethical compliance, the support program training content and mobile application usage will be opened to the control group. Women in the control group will have access to the application after study protocol.

Eligibility criteria: Inclusion Criteria:

* 18 years and over,
* Able to read and write,
* Agreeing to participate in the study,
* Accepting the decision of medical termination of pregnancy,
* Does not have a diagnosed psychiatric disease,
* Medical termination decision is taken in the first and second trimesters,
* Women who have a phone that can use the mobile application program will be included in the study.

Exclusion Criteria:

* Being under the age of 18,
* Those who do not agree to participate in the study,
* Women who do not have a phone that can use the mobile application program will not be included in the study.

Primary outcomes:
measure: perinatal grief-1
timeFrame: 2nd or 3rd days
measure: perinatal grief-2
timeFrame: 8th weeks
measure: perinatal grief-3
timeFrame: 12th weeks
measure: depression-anxiety-stress-1
timeFrame: 2nd or 3rd days
measure: depression-anxiety-stress-2
timeFrame: 8th weeks
measure: depression-anxiety-stress-3
timeFrame: 12th weeks
measure: coping and adaptation-1
timeFrame: first day
measure: coping and adaptation-2
timeFrame: 8th weeks
measure: coping and adaptation-3
timeFrame: 12th weeks
measure: Labor Pain-1
timeFrame: first day
measure: Labor Pain-2
timeFrame: first day
measure: Labor Pain-3
timeFrame: first day
Secondary outcomes:
measure: discharge time
timeFrame: Avarage 3-4 days
measure: quality of sleeping
timeFrame: 12th weeks
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi Üniversitesi
Study officials:
References: