Termination of PregnancyNCT05326854
NAVIGATION ASSISTED CARE PROGRAM AND TERMINATION OF PREGNANCY
A study testing supportive care in people with Termination of Pregnancy and Supportive Care, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Termination of Pregnancy, Supportive Care, Nursing Caries
- What is being tested?
- supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eskişehir Osmangazi Üniversitesi
Eskişehir, 26040
havva Yeşildere Sağlam, +905424829880, havvayesildere@gmail.com
Elif Gürsoy
About this study
Official title: EVALUATION OF THE EFFECTIVENESS OF THE NAVIGATION ASSISTED CARE PROGRAM FOR WOMEN WITH MEDICAL TERMINATION
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.
Read the 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.
- Conditions
- Termination of Pregnancy, Supportive Care, Nursing Caries
- Being tested
- supportive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supportive careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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 Receives: Other: supportive care |
| Control Group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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+
Measured: 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+
Measured: 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+
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: first day
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start30 Sep 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Termination of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, havva yeşildere sağlam, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326854
- Sponsor's protocol ID
- ESKISEHIROU1
- Status last verified
- Jun 2022
- First submitted
- 18 Mar 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yesildere Saglam H, Gursoy E, Kartal Y. The effect of nursing care during pregnancy termination on women's prenatal grief, depression, anxiety, stress and coping levels: A randomized controlled study. Women Health. 2025 Jan;65(1):92-106. doi: 10.1080/03630242.2024.2441377. Epub 2024 Dec 18.
PubMed 39696803
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECTIVENESS OF THE NAVIGATION ASSISTED CARE PROGRAM FOR WOMEN WITH MEDICAL TERMINATION
- ClinicalTrials.gov ID
- NCT05326854
- Acronym / sponsor ID
- ESKISEHIROU1
- Conditions
- Termination of Pregnancy, Supportive Care, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: supportive care1., 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 |
| Control Group | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supportive careAfter 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. | Other | intervention group |
Primary outcome
perinatal grief-1
Time frame: 2nd or 3rd days
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.
perinatal grief-2
Time frame: 8th weeks
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
perinatal grief-3
Time frame: 12th weeks
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
depression-anxiety-stress-1
Time frame: 2nd or 3rd days
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+
depression-anxiety-stress-2
Time frame: 8th weeks
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+
depression-anxiety-stress-3
Time frame: 12th weeks
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+
coping and adaptation-1
Time frame: first day
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.
coping and adaptation-2
Time frame: 8th weeks
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.
coping and adaptation-3
Time frame: 12th weeks
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.
Labor Pain-1
Time frame: first day
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.
Labor Pain-2
Time frame: first day
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.
Labor Pain-3
Time frame: first day
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.
2 secondary outcomes
discharge time
Time frame: Avarage 3-4 days
quality of sleeping
Time frame: 12th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Derived from this study: PubMed 39696803Yesildere Saglam H, Gursoy E, Kartal Y. The effect of nursing care during pregnancy termination on women's prenatal grief, depression, anxiety, stress and coping levels: A randomized controlled study. Women Health. 2025 Jan;65(1):92-106. doi: 10.1080/03630242.2024.2441377. Epub 2024 Dec 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supportive care in people with Termination of Pregnancy and Supportive Care, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perinatal grief-1 (time frame: 2nd or 3rd days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.