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

NCT ID: NCT04303949

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2021-07-30

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

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.

Conditions

Termination of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experimental

e-book for termination

Group Type: EXPERIMENTAL

Behavioral:

Intervention Type: OTHER

Facilitating couples reduce anxiety, depression and grief through e-book education.

Control

routine care Written form health education

Group Type: OTHER

Behavioral:

Intervention Type: OTHER

Facilitating couples reduce anxiety, depression and grief through e-book education.

Interventions

Behavioral:

Facilitating couples reduce anxiety, depression and grief through e-book education.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ya-Ling Tzeng, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, Taiwan

Central Contacts

SHU-YU LIN, Ms

Role: CONTACT

u105077002@cmu.edu.tw

04-22052121 ext. 3790

Ya-Ling Tzeng, PhD

Role: CONTACT

tyaling@mail.cmu.edu.tw

04-22053366 ext. 7112

Other Identifiers

CMUH108-REC1-077

Identifier Type: -

Identifier Source: org_study_id