The Effect of Nursing Care With Peri-Natal Loss

NCT06896214 | Not Yet Recruiting

• 2 other identifiers: Canan Uçakcı AsalıoğluNo funding support was receive
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Keywords

perinatal grief, perinatal loss,; Postpartum Depression; post-traumatic stress disorder

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

İntervention(Nursing care)

EXPERIMENTAL

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

Control (Standard care)

NO INTERVENTION

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.

Interventions

Standardised nursing care intervention OTHER

Standardised nursing care intervention

İntervention(Nursing care)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only women will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

MeSH Terms

Conditions

Depression, Postpartum; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, two of the researchers will carry out the application and the other researchers will be blinded. However, participant blinding will not be possible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 26, 2025
• Study Start: April 15, 2025
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL