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NCT Number: NCT06896214

The Effect of Nursing Care With Peri-Natal Loss

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standardised nursing care intervention

Other

Standardised nursing care intervention

Primary outcomes

  1. Peritanal grief scale

    Time frame: at the 1st and 3rd postpartum months. The perinatal grief scale is scored between 32-160

    • The mean PGS score will be evaluated at the 1st and 3rd postpartum months.
  2. Edinburgh Postpartum depression scale

    Time frame: Postpartum day 10, 1, 3 and 6 month. The Edinburgh Postpartum Depression Scale is scored between 0 and 30.

    • The mean EPDS score will be evaluated at postpartum day 10, 1, 3 and 6 months.
  3. Impact of Events Scale-revised

    Time frame: Postpartum 1, 3 and 6 months. The Impact of Events Scale is scored between 0 and 88.

    • The mean IESR score will be evaluated at 1, 3 and 6 months.
  4. Complicated grief scale

    Time frame: At the 6th postpartum month.The Complicated Grief Scale is scored between 0 and 55. As the score increases, the severity of grief increases.

    At the 6th postpartum month, the mean score of the CGS will be evaluated.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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