Multi-Media E-Book for Second-Trimester Termination Due to Fetal Anomaly
Primary Purpose
Termination of Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral:
Sponsored by
About this trial
This is an interventional other trial for Termination of Pregnancy focused on measuring Termination, Fetal anomaly, Gender, Grief, Nursing, e-book
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental
Control
Arm Description
e-book for termination
routine care Written form health education
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04303949
First Posted
December 3, 2019
Last Updated
March 9, 2020
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04303949
Brief Title
Multi-Media E-Book for Second-Trimester Termination Due to Fetal Anomaly
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2020 (Anticipated)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Study design: The study subjects were couples of obstetric inpatients who would receive termination of pregnancy. Both groups were assessed by the obstetrician in the outpatient clinic who must be admitted to the hospital to terminate the pregnancy. After receiving consent, a pre-test is performed in the clinic. The pre-test included questionnaires (basic attribute, State-Trait Anxiety Inventory (STAI) - the State Anxiety Scale (S-Anxiety), Perinatal Grief Scale (PGS), Beck Depression Inventory). After complete pre-teat, study nurse will provide the experimental group a QR Code to enter the cloud system (Hama Star e-book network platform), enable the couples to read the content at home; the control group receives traditional oral instructions. When the experimental group entered the delivery room, the researcher used the Hama Star e-book network platform to play the content of the termination of pregnancy e-book education model, and discussed the content with them; the control group receives regular traditional education model, with booklet and oral instructions, the intervention is about 20-25 minutes. The experimental group is able to use e-books as needed during induction, hospitalization, and after discharge. Two post-tests are conducted for follow-up. Both groups write the first post-test questionnaire (State-Trait Anxiety Inventory (STAI) - the State Anxiety Scale (S-Anxiety), Perinatal Grief Scale (PGS), Beck Depression Inventory) 60 minutes after education. Then, complete the second post-test questionnaire at the next appointment a month after.
Randomization Process: This study used a two-group pre- and post-test mode in experimental design, and random allocation to assign subjects into experimental and control groups. Participants were randomly allocated to the experimental or control group in a 1:1 ratio using the network randomization tool (www.randomizer.org/).
Sample size calculation:G-power version 3.1 was used to calculate the required sample size for the study. Set power 0.8, α = 0.05, based on the effectiveness (effect 0.30), the number of samples required for each group in this study is 32, because the tracking period is up to half a year, with a loss rate 50%, the two groups need a total of 96 participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Termination of Pregnancy
Keywords
Termination, Fetal anomaly, Gender, Grief, Nursing, e-book
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
e-book for termination
Arm Title
Control
Arm Type
Other
Arm Description
routine care Written form health education
Intervention Type
Other
Intervention Name(s)
Behavioral:
Intervention Description
Facilitating couples reduce anxiety, depression and grief through e-book education.
Primary Outcome Measure Information:
Title
Change in Anxiety level
Description
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.
Time Frame
The experimental group and the control group will accept the pretest and post-test before intervention, take another test after one month.
Title
Change in Grief Level
Description
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.
Time Frame
The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
Title
Change in Depression Level
Description
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.
Time Frame
The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
Title
Learning Motivational Change
Description
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.
Time Frame
The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SHU-YU LIN, Ms
Phone
04-22052121
Ext
3790
Email
u105077002@cmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Ling Tzeng, PhD
Phone
04-22053366
Ext
7112
Email
tyaling@mail.cmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-Ling Tzeng, PhD
Organizational Affiliation
China Medical University, Taiwan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Multi-Media E-Book for Second-Trimester Termination Due to Fetal Anomaly
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