NAVIGATION ASSISTED CARE PROGRAM AND TERMINATION OF PREGNANCY

NCT05326854 | Unknown

• 1 other identifier: ESKISEHIROU1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Termination of Pregnancy; Supportive Care; Nursing Caries

Outcome Measures

Primary Outcomes (12)

• 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.

  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

  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

  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+

  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+

  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+

  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.

  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.

  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.

  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.

  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.

  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.

  first day

Secondary Outcomes (2)

• discharge time

  Avarage 3-4 days

• quality of sleeping

  12th weeks

Study Arms (2)

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

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

Interventions

supportive care OTHER

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskişehir Osmangazi Üniversitesi

Eskişehir, 26040, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 39696803 DERIVED

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 14, 2022
• Study Start: September 30, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

TU (1)