The Effect of Nursing Care With Peri-Natal Loss

The Effect of Standardised Nursing Care Given to Women With Peri-Natal Loss on Peri-Natal Grief, Posttraumatic Stress, Postpartum Depression

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perinatal Grief; Perinatal Loss
• Intervention / Treatment: Other: Standardised nursing care intervention

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:- To be over 18 years old

• 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

Exclusion Criteria:Women who agreed to participate in the study but did not want to receive post-discharge care, who were hospitalised for any reason, who became pregnant again, who did not want to complete the last tests or who wanted to leave the study at any stage of the study will be excluded from the sample.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Standardised nursing care intervention; Standardised nursing care intervention
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peritanal grief scale	- The mean PGS score will be evaluated at the 1st and 3rd postpartum months.	at the 1st and 3rd postpartum months. The perinatal grief scale is scored between 32-160
Edinburgh Postpartum depression scale	- The mean EPDS score will be evaluated at postpartum day 10, 1, 3 and 6 months.	Postpartum day 10, 1, 3 and 6 month. The Edinburgh Postpartum Depression Scale is scored between 0 and 30.
Impact of Events Scale-revised	- The mean IESR score will be evaluated at 1, 3 and 6 months.	Postpartum 1, 3 and 6 months. The Impact of Events Scale is scored between 0 and 88.
Complicated grief scale	At the 6th postpartum month, the mean score of the CGS will be evaluated.	At the 6th postpartum month.The Complicated Grief Scale is scored between 0 and 55. As the score increases, the severity of grief increases.

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Postpartum Depression; post-traumatic stress disorder; perinatal grief, perinatal loss,
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: Canan Uçakcı Asalıoğlu; No funding support was receive (Registry Identifier: No funding support was received for this study.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No