Pregnancy LossNCT06605274
Effectiveness Web-based Training on Perinatal Loss
A study testing Web-Based Education Program in people with Pregnancy Loss and Psychological Distress, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted in a randomized controlled parallel group experimental design to determine the effect of web-based supportive care provided to women who experienced perinatal loss on perinatal grief, depression, hopelessness and coping with stress. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Loss, Psychological Distress, Depression
- What is being tested?
- Web-Based Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- spoke Turkish, had at least primary school level education
- did not have a psychiatric disease diagnosis
- could use and access the internet and information technologies
- did not have vision and hearing problems
- experienced pregnancy loss of 12 weeks or more
- were hospitalized in the perinatology clinic
Who cannot join
- Women who did not accept to participate in the study
- did not use the internet and information technologies and could not access them
- applied to psychological support units during the training process
- started using psychiatric medication during the training process were not included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University
Bolu, Merkez, 14000
About this study
Official title: Web-based Training Given to Women Who Have Experienced Perinatal Loss the Effect of Psychosocial Well-being
The study was conducted in a randomized controlled parallel group experimental design to determine the effect of web-based supportive care provided to women who experienced perinatal loss on perinatal grief, depression, hopelessness and coping with stress.
Read the detailed description
Loss, which includes many complex emotions, is the loss of a person or object that is valuable to the individual after having it. Perinatal loss is the most painful situation that pregnancy can potentially result in. With perinatal loss, parents may show behavioral (shock, anger and loneliness) and physical (crying, loss of appetite or overeating, insomnia, irritability, inability to concentrate, forgetfulness, pain, etc.) reactions. However, emotional problems such as grief and depression after loss are more common than physical and behavioral problems. While the prevalence of major depression in society is 3-10%, this rate varies between 10-51% in those who experience perinatal loss. Loss can become a life crisis with biopsychosocial and spiritual dimensions for parents and especially for women.
- Conditions
- Pregnancy Loss, Psychological Distress, Depression
- Being tested
- Web-Based Education Program, Control
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Education ProgramOther
Before being discharged from the clinic, the women who experienced perinatal loss filled out the Personal Information Form, Perinatal Grief Scale, Edinburgh Postnatal Depression Scale, Beck Hopelessness Scale, and Stress Coping Styles Scale individually. The women were informed about the use of the website. The discharged women were contacted by phone, given the passwords of the "birliktegücleniyoruz.com" website, and invited to use the website for the five-week education program. Each week, only one session determined for that week was uploaded to the site. Participants who wished to do so were able to watch the uploaded sessions more than once. Retrospective sessions also remained accessible on the site. Each session lasted an average of 20-30 minutes. Women who completed five sessions were contacted by phone in the sixth week. Women filled out the PGS, EPDS, BHS, and SCSS online a second time
ControlOther
Before being discharged from the perinatology clinic, the women filled out the Personal Information Form, PGS, EPDS, BHS, and SCSS individually. Six weeks after discharge, the participants filled out the same measurement tools online again. During this process, the hospital's routine monitoring continued for the control group. The website was opened to the use of participants who wanted to use the site after the completion of the final tests.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based Education Group | Other | The technology-based education program prepared for women experiencing perinatal loss was prepared based on current literature and care theories related to perinatal loss. The program consisted of five modules, namely "What I am experiencing, I am ready to learn", "I have a loss and I am ready to experience my mourning process", "I am experiencing my loss and I do not have to be alone", "I am ready to look back and explore", and "create a memory, move on". Expert opinions were obtained for the content of the program. Necessary adjustments were made to the program in line with expert opinions. Receives: Other: Web-Based Education Program |
| Control Group | Active comparator | A conventional post discharge follow up was performed on control group no other intervention was applied. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal Grief Scale (PGS)
The scale that evaluates the grief experienced after perinatal loss was developed by Toedter et al. The validity and reliability of the Turkish version of the scale was performed by Köneş et al. PGS consists of three sub-dimensions and is a 5-point Likert type.
Measured: six weeks
Edinburgh Postnatal Depression Scale (EPDS)
The scale was developed by Cox and Hodden to determine the risk of postnatal depression. Its Turkish adaptation was made by Engindeniz et al. EPDS consists of 10 items and is a 4-point Likert type. The items are scored between 0-3.
Measured: six weeks
Beck Hopelessness Scale (BHS)
It was developed by Beck, Trexler and Lester to determine individuals' hopelessness about the future. Its Turkish validity and reliability study was conducted by Seber et al. The scale consists of 20 items and three sub-dimensions. Scale items are scored between 0-1.
Measured: six weeks
Stress Coping Styles Scale (SCSS)
The scale was created by Folkman and Lazarus to determine individuals' coping with stress. It was adapted to Turkish by Şahin and Durak. The scale consists of 30 items, five sub-dimensions, and is a 4-point Likert-type scale. The items in the scale are scored between 0 and 3. The sub-dimensions of the scale are "self-confident approach", "optimistic approach", "submissive approach", "helpless approach" and "seeking social support". The score obtained from the relevant sub-dimensions indicates that the individual uses the mentioned approach more
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jul 2023
- Primary completion1 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy LossStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective parallel two group unmasked prevention study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevin Çıtak BİLGİN, Abant Izzet Baysal University
- Investigators
- Nevin Bilgin, PhD, Study director, Abant Izzet Baysal UniversityTuba Ünal, Msc, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605274
- Sponsor's protocol ID
- AIBU-SBF-NB-01
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing plan was determined
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Training Given to Women Who Have Experienced Perinatal Loss the Effect of Psychosocial Well-being
- ClinicalTrials.gov ID
- NCT06605274
- Acronym / sponsor ID
- AIBU-SBF-NB-01
- Conditions
- Pregnancy Loss, Psychological Distress, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Sep 2024 (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.
The study was conducted in a randomized controlled parallel group experimental design to determine the effect of web-based supportive care provided to women who experienced perinatal loss on perinatal grief, depression, hopelessness and coping with stress.
Detailed description
Loss, which includes many complex emotions, is the loss of a person or object that is valuable to the individual after having it. Perinatal loss is the most painful situation that pregnancy can potentially result in. With perinatal loss, parents may show behavioral (shock, anger and loneliness) and physical (crying, loss of appetite or overeating, insomnia, irritability, inability to concentrate, forgetfulness, pain, etc.) reactions. However, emotional problems such as grief and depression after loss are more common than physical and behavioral problems. While the prevalence of major depression in society is 3-10%, this rate varies between 10-51% in those who experience perinatal loss. Loss can become a life crisis with biopsychosocial and spiritual dimensions for parents and especially for women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective parallel two group unmasked prevention study
| Arm | Type | Receives |
|---|---|---|
| Web-Based Education Group | Other | Other: Web-Based Education ProgramThe technology-based education program prepared for women experiencing perinatal loss was prepared based on current literature and care theories related to perinatal loss. The program consisted of five modules, namely "What I am experiencing, I am ready to learn", "I have a loss and I am ready to experience my mourning process", "I am experiencing my loss and I do not have to be alone", "I am ready to look back and explore", and "create a memory, move on". Expert opinions were obtained for the content of the program. Necessary adjustments were made to the program in line with expert opinions. |
| Control Group | Active comparator | Other: ControlA conventional post discharge follow up was performed on control group no other intervention was applied. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- spoke Turkish, had at least primary school level education
- did not have a psychiatric disease diagnosis
- could use and access the internet and information technologies
- did not have vision and hearing problems
- experienced pregnancy loss of 12 weeks or more
Key exclusion criteria (4 listed)
- Women who did not accept to participate in the study
- did not use the internet and information technologies and could not access them
- applied to psychological support units during the training process
- started using psychiatric medication during the training process were not included in the study
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 |
|---|---|---|
| Web-Based Education ProgramBefore being discharged from the clinic, the women who experienced perinatal loss filled out the Personal Information Form, Perinatal Grief Scale, Edinburgh Postnatal Depression Scale, Beck Hopelessness Scale, and Stress Coping Styles Scale individually. The women were informed about the use of the website. The discharged women were contacted by phone, given the passwords of the "birliktegücleniyoruz.com" website, and invited to use the website for the five-week education program. Each week, only one session determined for that week was uploaded to the site. Participants who wished to do so were able to watch the uploaded sessions more than once. Retrospective sessions also remained accessible on the site. Each session lasted an average of 20-30 minutes. Women who completed five sessions were contacted by phone in the sixth week. Women filled out the PGS, EPDS, BHS, and SCSS online a second time | Other | Web-Based Education Group |
| ControlBefore being discharged from the perinatology clinic, the women filled out the Personal Information Form, PGS, EPDS, BHS, and SCSS individually. Six weeks after discharge, the participants filled out the same measurement tools online again. During this process, the hospital's routine monitoring continued for the control group. The website was opened to the use of participants who wanted to use the site after the completion of the final tests. | Other | Control Group |
Primary outcome
Perinatal Grief Scale (PGS)
Time frame: six weeks
The scale that evaluates the grief experienced after perinatal loss was developed by Toedter et al. The validity and reliability of the Turkish version of the scale was performed by Köneş et al. PGS consists of three sub-dimensions and is a 5-point Likert type.
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: six weeks
The scale was developed by Cox and Hodden to determine the risk of postnatal depression. Its Turkish adaptation was made by Engindeniz et al. EPDS consists of 10 items and is a 4-point Likert type. The items are scored between 0-3.
Beck Hopelessness Scale (BHS)
Time frame: six weeks
It was developed by Beck, Trexler and Lester to determine individuals' hopelessness about the future. Its Turkish validity and reliability study was conducted by Seber et al. The scale consists of 20 items and three sub-dimensions. Scale items are scored between 0-1.
Stress Coping Styles Scale (SCSS)
Time frame: six weeks
The scale was created by Folkman and Lazarus to determine individuals' coping with stress. It was adapted to Turkish by Şahin and Durak. The scale consists of 30 items, five sub-dimensions, and is a 4-point Likert-type scale. The items in the scale are scored between 0 and 3. The sub-dimensions of the scale are "self-confident approach", "optimistic approach", "submissive approach", "helpless approach" and "seeking social support". The score obtained from the relevant sub-dimensions indicates that the individual uses the mentioned approach more
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No. no data sharing plan was determined
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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. This study is not recruiting at the moment.
Nevin Bilgin, PhD study director
Abant Izzet Baysal University
Tuba Ünal, Msc principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Education Program in people with Pregnancy Loss and Psychological Distress, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perinatal Grief Scale (PGS) (time frame: six weeks). 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 20 Sep 2024.