Clinical trial NCT04303949: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Termination of Pregnancy
Keywords: Termination
Fetal anomaly
Gender
Grief
Nursing
e-book
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Anxiety level
timeFrame: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after one month.
measure: Change in Grief Level
timeFrame: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
measure: Change in Depression Level
timeFrame: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
measure: Learning Motivational Change
timeFrame: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: China Medical University, Taiwan
name: Ya-Ling Tzeng, PhD
role: PRINCIPAL_INVESTIGATOR
References: