Multi-Media E-Book for Second-Trimester Termination Due to Fetal Anomaly
Apply Gender Perspective Based Multi-media E-book to Enhance the Care Quality of a Second-Trimester Termination Due to Fetal Anomaly：for Parents and Nursing Professionals
1 other identifier
interventional
96
0 countries
N/A
Brief Summary
The subjects of this study are married couples who received termination of pregnancy, the main purpose is to explore the effectiveness of the e-book education model. Outcome indicators include anxiety, depression, and grief, as well as the satisfaction of the education.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedStudy Start
First participant enrolled
March 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedMarch 11, 2020
March 1, 2020
1.4 years
December 3, 2019
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in Anxiety level
State-Trait Anxiety Inventory State Anxiety (STAI-S) is used to measure the anxiety levels. State Anxiety refers to a temporary emotional state that changes over time, including the subjective perception of tension, anxiety, and fear. A total of 20 questions, the higher the score, the higher the degree of anxiety, the lower the score, the lighter the degree of anxiety. 20 - 39 means mild anxiety; 40 - 59 means moderate anxiety; 60 - 80 means severe anxiety. This scale has been widely used for many years to measure the anxiety of various conditions and has good reliability and validity.
The experimental group and the control group will accept the pretest and post-test before intervention, take another test after one month.
Change in Grief Level
This study used the Perinatal Grief Scale (PGS) (1989) as a tool to measure the degree of a grief response, and Cronbach α value is 0.95. The questionnaire includes three aspects of Active Grief, Difficulty Coping and Despair, each aspect has 11 questions, a total of 33 questions. The total amount is calculated by the degree of sadness, from "very agree" to 1 point, "disagree" to 2 points, "not agreeing or denying" 3 Points, "Agree" 4 points, "very agree" 5 points, the total score is 33-165 points, the higher the score, the higher the level of sadness. It can be used as a measurement for predicting subjects with long-term grief.
The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
Change in Depression Level
Beck Depression Inventory (BDI-II) is used to measure the level of depression. The content of the scale contains a total of 21 questions, each of which has four options according to the severity level, and scores ranging from 0 to 3 points.
The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
Learning Motivational Change
Include learning motivation of sexual harassment Contains the learner's attention to the teaching material (12 questions), relevance (9 questions), confidence (9 questions), satisfaction (6 questions) and other learning motivation, a total of 36 questions, use Likert five-point scale, scoring method from 5 (very agreeable) to 1 (very disagree), the score range from 36-180 points, the higher the total score of the scale, the stronger the motivation of learning.
The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
Study Arms (2)
Experimental
EXPERIMENTALe-book for termination
Control
OTHERroutine care Written form health education
Interventions
Facilitating couples reduce anxiety, depression and grief through e-book education.
Eligibility Criteria
You may qualify if:
- At least 20 years old
- Consciousness clear and capable of complete the questionnaires
- Able to communicate in Mandarin or Taiwanese
- Agree to participate in the study and sign the consent
You may not qualify if:
- Emergency admissions for induction.
- Non-medical reasons and pay own expenses to terminate the pregnancy
- Have psychiatric illness history or other disorders that affect cognitive function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ya-Ling Tzeng, PhD
China Medical University, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2019
First Posted
March 11, 2020
Study Start
March 20, 2020
Primary Completion
July 30, 2021
Study Completion
July 30, 2021
Last Updated
March 11, 2020
Record last verified: 2020-03