Clinical trial NCT06896214: The Effect of Nursing Care With Peri-Natal Loss
Official title: The Effect of Standardised Nursing Care Given to Women With Peri-Natal Loss on Peri-Natal Grief, Posttraumatic Stress, Postpartum Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perinatal Loss
Perinatal Grief
Keywords: perinatal grief, perinatal loss,
Postpartum Depression
post-traumatic stress disorder
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Peritanal grief scale
timeFrame: at the 1st and 3rd postpartum months. The perinatal grief scale is scored between 32-160
measure: Edinburgh Postpartum depression scale
timeFrame: Postpartum day 10, 1, 3 and 6 month. The Edinburgh Postpartum Depression Scale is scored between 0 and 30.
measure: Impact of Events Scale-revised
timeFrame: Postpartum 1, 3 and 6 months. The Impact of Events Scale is scored between 0 and 88.
measure: Complicated grief scale
timeFrame: At the 6th postpartum month.The Complicated Grief Scale is scored between 0 and 55. As the score increases, the severity of grief increases.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: