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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
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 20 years old
  2. Consciousness clear and capable of complete the questionnaires
  3. Able to communicate in Mandarin or Taiwanese
  4. Agree to participate in the study and sign the consent

Exclusion Criteria:

  1. Emergency admissions for induction.
  2. Non-medical reasons and pay own expenses to terminate the pregnancy
  3. 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

    First Posted
    December 3, 2019
    Last Updated
    March 9, 2020
    Sponsor
    China Medical University Hospital
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    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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