The Effect of Nursing Care With Peri-Natal Loss

NCT ID: NCT06896214

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-12-30

Brief Summary

This study was planned to evaluate the effect of standardised nursing care given to women with perinatal loss using the nursing process on perinatal grief, posttraumatic stress and postpartum depression.

H01: There is no difference between pre-test, post-test and follow-up tests in terms of perinatal grief scale mean scores in the intervention group.

H02: There is no difference between pre-test, post-test and follow-up tests in terms of IES-R mean scores in the intervention group.

H03: There is no difference between pre-test, post-test and follow-up tests in terms of EPDS mean scores in the intervention group.

H04: There is no difference between the pre-test post-test and follow-up tests in terms of the mean scores of the Complicated Grief Scale in the intervention group.

• At the first encounter with women, the mean scores of PMI, IESR and EPDS will be evaluated.
• The mean EPDS score will be evaluated on the 10th postpartum day, 1st, 3rd and 6th month.
• The mean I-ESR scale score will be evaluated at postpartum 1st, 3rd and 6th month.
• At postpartum 1st and 3rd month, the mean score of PMS will be evaluated.
• At the postpartum 6th month, the mean score of the PBI scale will be evaluated.

Conditions

Perinatal Loss; Perinatal Grief

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

İntervention(Nursing care)

After the women are discharged, tele-nursing care will be provided by evaluating them through a telephone application that allows online interviews. In this context, three interviews will be conducted on the second day, seventh day and 15th day after discharge. EPDS will be administered on the 10th day after discharge, EPDS, I-ESR, PMS will be administered at the 1st month, 3rd month, 6th month, and prolonged grief scale (PBS) will be administered only at the 6th month. The scales will be converted into an online questionnaire and sent to the participants and will be filled in.

Group Type: EXPERIMENTAL

Standardised nursing care intervention

Intervention Type: OTHER

Standardised nursing care intervention

Control (Standard care)

Women in the control group will receive the standard care provided in the hospital. EPDS will be administered on the 10th day after discharge, EPDS, I-ESR, PMS at the 1st month, 3rd month, 6th month and prolonged grief scale (PBS) only at the 6th month. The scales will be converted into an online questionnaire and sent to the participants and will be filled in.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Standardised nursing care intervention

Standardised nursing care intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being married (according to the woman's declaration)
• Not having an existing psychiatric illness (according to the woman's declaration)
• Not having communication problems (knowing Turkish, being literate, not having vision, speech or hearing problems, etc.)
• Spontaneous conception
• Singleton pregnancy
• No substance addiction

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Canan Uçakçı Asalıoğlu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

No funding support was receive

Identifier Type: REGISTRY

Identifier Source: secondary_id

Canan Uçakcı Asalıoğlu

Identifier Type: -

Identifier Source: org_study_id