Termination of PregnancyNCT04303949
Multi-Media E-Book for Second-Trimester Termination Due to Fetal Anomaly
A study testing Behavioral: in people with Termination of Pregnancy, run by China Medical University Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Termination of Pregnancy
- What is being tested?
- Behavioral:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Termination of Pregnancy
- Being tested
- Behavioral:
- Keywords
- Termination, Fetal anomaly, Gender, Grief, Nursing, e-book
- Medical subject headings
- Congenital Abnormalities, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral:Other
Facilitating couples reduce anxiety, depression and grief through e-book education.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | e-book for termination Receives: Other: Behavioral: |
| Control | Other | routine care Written form health education Receives: Other: Behavioral: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after one month.
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.
Measured: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
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.
Measured: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
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.
Measured: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start20 Mar 2020 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Termination of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Ling Tzeng, PhD, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303949
- Sponsor's protocol ID
- CMUH108-REC1-077
- Status last verified
- Mar 2020
- First submitted
- 3 Dec 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04303949
- Acronym / sponsor ID
- CMUH108-REC1-077
- Conditions
- Termination of Pregnancy
- Keywords
- Termination, Fetal anomaly, Gender, Grief, Nursing, e-book
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2020 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Behavioral:e-book for termination |
| Control | Other | Other: Behavioral:routine care Written form health education |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral:Facilitating couples reduce anxiety, depression and grief through e-book education. | Other | Control, Experimental |
Primary outcome
Change in Anxiety level
Time frame: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after one month.
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
Time frame: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
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
Time frame: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
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
Time frame: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after six months.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-Ling Tzeng, PhD principal investigator
China Medical University, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: in people with Termination of Pregnancy, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SHU-YU LIN, Ms (04-22052121 ext. 3790, u105077002@cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety level (time frame: The experimental group and the control group will accept the pretest and post-test before intervention, take another test after one month.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.