Perinatal LossNCT06896214
The Effect of Nursing Care With Peri-Natal Loss
A study testing Standardised nursing care intervention in people with Perinatal Loss and Perinatal Grief, run by Gazi University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Perinatal Loss, Perinatal Grief
- What is being tested?
- Standardised nursing care intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
Official title: 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.
Read more
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
- Being tested
- Standardised nursing care intervention
- Keywords
- perinatal grief, perinatal loss,, Postpartum Depression, post-traumatic stress disorder
- Medical subject headings
- Depression, Postpartum, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised nursing care interventionOther
Standardised nursing care intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritanal grief scale
- The mean PGS score will be evaluated at the 1st and 3rd postpartum months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the 6th postpartum month.The Complicated Grief Scale is scored between 0 and 55. As the score increases, the severity of grief increases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal LossStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Uçakçı Asalıoğlu, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896214
- Sponsor's protocol ID
- Canan Uçakcı Asalıoğlu
- Other IDs
- No funding support was receive
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Standardised Nursing Care Given to Women With Peri-Natal Loss on Peri-Natal Grief, Posttraumatic Stress, Postpartum Depression
- ClinicalTrials.gov ID
- NCT06896214
- Acronym / sponsor ID
- Canan Uçakcı Asalıoğlu
- Conditions
- Perinatal Loss, Perinatal Grief
- Keywords
- perinatal grief, perinatal loss,, Postpartum Depression, post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention(Nursing care) | Experimental | Other: Standardised nursing care interventionAfter 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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised nursing care interventionStandardised nursing care intervention | Other | İntervention(Nursing care) |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standardised nursing care intervention in people with Perinatal Loss and Perinatal Grief, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritanal grief scale (time frame: at the 1st and 3rd postpartum months. The perinatal grief scale is scored between 32-160). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.