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
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.
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.
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