Effectiveness Web-based Training on Perinatal Loss

September 18, 2024 updated by: Nevin Çıtak BİLGİN, Abant Izzet Baysal University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Bolu, Merkez, Turkey, 14000
        • Bolu abant Izzet Baysal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Web-Based Education Group
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.
Other: Web-Based Education Program
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
Active Comparator: Control Group
A conventional post discharge follow up was performed on control group no other intervention was applied.
Other: Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
six weeks
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.
six weeks
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.
six weeks
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
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abant Izzet Baysal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nevin Bilgin, PhD, Abant Izzet Baysal University
  • Principal Investigator: Tuba Ünal, Msc, Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIBU-SBF-NB-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no data sharing plan was determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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