Effectiveness Web-based Training on Perinatal Loss

NCT ID: NCT06605274

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2023-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Web-Based Education Program

Intervention Type: OTHER

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

Control Group

A conventional post discharge follow up was performed on control group no other intervention was applied.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Nevin Çıtak BİLGİN

Assoc. Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nevin Bilgin, PhD

Role: STUDY_DIRECTOR

Abant Izzet Baysal University

Tuba Ünal, Msc

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

Bolu Abant Izzet Baysal University

Bolu, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AIBU-SBF-NB-01

Identifier Type: -

Identifier Source: org_study_id