Effectiveness Web-based Training on Perinatal Loss

NCT06605274 | Completed

• 1 other identifier: AIBU-SBF-NB-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Loss; Psychological Distress; Depression

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  six weeks

Study Arms (2)

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.

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.

Other: Control

Interventions

Web-Based Education Program 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

Web-Based Education Group

Control 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Merkez, 14000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Nevin Bilgin, PhD

  Abant Izzet Baysal University

  STUDY DIRECTOR

• Tuba Ünal, Msc

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking used in this study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Model Details: Prospective parallel two group unmasked prevention study

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)