Multi-Media E-Book for Second‐Trimester Termination Due to Fetal Anomaly

Termination of Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04303949
• Other study ID #: CMUH108-REC1-077
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: March 2020
• Source: China Medical University Hospital
• Contact: SHU-YU LIN, Ms
• Phone: 04-22052121
• Email: u105077002[@]cmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. 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.

2. 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/).

3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Termination of Pregnancy

Intervention

Other:
• Behavioral:
Facilitating couples reduce anxiety, depression and grief through e-book education.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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 a 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.
Primary	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.
Primary	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.