Self EfficacyNCT05253001
Effects of Antenatal Education on Maternal Childbirth
A study testing smartphone in people with Self Efficacy and Maternal Behavior, run by Taipei Medical University.
Trial summary
In prenatal education, pregnant women's knowledge is a crucial issue for protecting pregnant women and newborns healthy. Therefore, prenatal education has become a basic and essential program for each pregnant woman. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy, Maternal Behavior
- What is being tested?
- smartphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Aug 2022
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parturients who have come to the hospital for obstetrics
Who cannot join
- Parturients who have ever to the hospital for obstetrics
About this study
Official title: Effects of Antenatal Education on Maternal Childbirth Self-efficacy and Satisfaction
In prenatal education, pregnant women's knowledge is a crucial issue for protecting pregnant women and newborns healthy. Therefore, prenatal education has become a basic and essential program for each pregnant woman. However, most of the current prenatal education courses are taught via a group teaching approach, which makes it difficult for pregnant women to think deeply about relevant birth issues due to the lack of interaction and context. This may in turn have an impact on childbirth choice and clinical judgment.
Read the detailed description
My study Purpose wants to see doseThe mobile chatbot approach improve prenatal education shared decision-making. In order to verify the effectiveness of such a learning design, an experiment was developed in the current study. A total of 40 women from a medical hospital in northern Taiwan were recruited as the participants.
- Conditions
- Self Efficacy, Maternal Behavior
- Being tested
- smartphone
- Keywords
- maternal self-efficacy, maternal education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphoneDevice
Use the mobile chatbot approach for intervention groups to improve prenatal education.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | use mobile chatbot approach to improve prenatal education Receives: Device: smartphone |
| controp group | Placebo comparator | a traditional approach to prenatal education Receives: Device: smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of antenatal education on maternal childbirth self-efficacy and satisfaction
The study will be using the maternal childbirth self-efficacy questionnaire to survey the participants' use outcomes related the smartphone use.
Measured: the outcome measure will be assessed through study completion and data will be reported up to 1 year.
Effects of antenatal education on maternal childbirth self-efficacy and satisfaction
The study will use the maternal childbirth satisfaction questionnaire to survey the participants' childbirth experience related to smartphone use.
Measured: the outcome measure will be assessed through study completion and data will be reported up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- An experiment was developed in the current study. A total of 40 women from a medical hospital in northern Taiwan were recruited as the participants. The study groups mobile chatbot approach to improving prenatal education. The controp group was a traditional approach to prenatal education.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ching-Yi Chang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253001
- Sponsor's protocol ID
- TMU109-AE1-B25
- Status last verified
- Apr 2022
- First submitted
- 5 Jan 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antenatal Education on Maternal Childbirth Self-efficacy and Satisfaction
- ClinicalTrials.gov ID
- NCT05253001
- Acronym / sponsor ID
- TMU109-AE1-B25
- Conditions
- Self Efficacy, Maternal Behavior
- Keywords
- maternal self-efficacy, maternal education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 23 Feb 2022 (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.
In prenatal education, pregnant women's knowledge is a crucial issue for protecting pregnant women and newborns healthy. Therefore, prenatal education has become a basic and essential program for each pregnant woman. However, most of the current prenatal education courses are taught via a group teaching approach, which makes it difficult for pregnant women to think deeply about relevant birth issues due to the lack of interaction and context. This may in turn have an impact on childbirth choice and clinical judgment.
Detailed description
My study Purpose wants to see doseThe mobile chatbot approach improve prenatal education shared decision-making. In order to verify the effectiveness of such a learning design, an experiment was developed in the current study. A total of 40 women from a medical hospital in northern Taiwan were recruited as the participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- An experiment was developed in the current study. A total of 40 women from a medical hospital in northern Taiwan were recruited as the participants. The study groups mobile chatbot approach to improving prenatal education. The controp group was a traditional approach to prenatal education.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: smartphoneuse mobile chatbot approach to improve prenatal education |
| controp group | Placebo comparator | Device: smartphonea traditional approach to prenatal education |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Parturients who have come to the hospital for obstetrics
Key exclusion criteria (1 listed)
- Parturients who have ever to the hospital for obstetrics
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 |
|---|---|---|
| smartphoneUse the mobile chatbot approach for intervention groups to improve prenatal education. | Device | controp group, study group |
Primary outcome
Effects of antenatal education on maternal childbirth self-efficacy and satisfaction
Time frame: the outcome measure will be assessed through study completion and data will be reported up to 1 year.
The study will be using the maternal childbirth self-efficacy questionnaire to survey the participants' use outcomes related the smartphone use.
Effects of antenatal education on maternal childbirth self-efficacy and satisfaction
Time frame: the outcome measure will be assessed through study completion and data will be reported up to 1 year.
The study will use the maternal childbirth satisfaction questionnaire to survey the participants' childbirth experience related to smartphone use.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing smartphone in people with Self Efficacy and Maternal Behavior, run by Taipei Medical University.
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 1 inclusion and 1 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 27 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of antenatal education on maternal childbirth self-efficacy and satisfaction (time frame: the outcome measure will be assessed through study completion and data will be reported up to 1 year.). The study lists 2 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 27 Apr 2022.