Normal PregnancyNCT03692923
VIRTUAL COMMUNITY for PREGNANT WOMEN
A study testing virtual community in people with Normal Pregnancy, run by Tzu Chi University.
Trial summary
The study aimed to investigate the effect of exclusive peer-to-peer virtual support on pregnant women's well-being including physical symptoms, depression, social support, maternal attachment, and pregnancy adaptation. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Pregnancy
- What is being tested?
- virtual community
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2012to 31 Jan 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women were older than 20 years old
- Had at least 9 years of education.
Who cannot join
- Had complications in this pregnancy
- Had underlying medical problems with pregnancy.
About this study
Official title: Impact of A Peer Virtual Community on Pregnant Women's Well-being: A Quasi-experimental Study
The study aimed to investigate the effect of exclusive peer-to-peer virtual support on pregnant women's well-being including physical symptoms, depression, social support, maternal attachment, and pregnancy adaptation.
Read the detailed description
The pregnancy period is marked by not only the joy and excitement of bonding with her baby but also dramatic changes in her body. The Internet's convenience and anonymity provide great possibilities for pregnant women to create a social network for sharing personal stories, seeking information and asking questions, and expressing own emotions and concerns.
Although health-related online communities are emerging rapidly around the globe, little is known about the impact of a virtual peer community on pregnant women's well-being.
The study enrolled 138 pregnant women, who were assigned to either the experimental or control groups. After obtaining informed consent from participants, we asked them to fill out the baseline questionnaires (Time 1). The first and second follow-ups (Times 2 and 3) were conducted at 22-24 and 36-38 weeks of pregnancy, respectively. Participants in the experimental group received ordinary prenatal care in addition to virtual community participation, and those in the control group received only ordinary prenatal care.
- Conditions
- Normal Pregnancy
- Being tested
- virtual community
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual communityOther
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | participants received ordinary prenatal care. |
| virtual community group | Experimental | participants were invited to join a virtual community to interact with peers in addition to their ordinary prenatal care. Receives: Other: virtual community |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pregnancy adaptation scale
Used to investigate the changes in the scores of pregnancy adaptation. Items are scored from 0 to 3 and they are summed to compute a total score ranging from 0 to 84. Higher scores indicate better pregnancy adaptation.
Measured: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
The Edinburgh Depression Scale
Used to investigate the changes in the scores of depression. Items are scored from 0 to 3 and they are summed to compute a total score ranging from 0 to 30. The cut-off point for depression is a total score of 12 or above.
Measured: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
Secondary outcomes (3)
The Symptoms Checklist
Used to investigate the changes in the scores of pregnancy-related physical symptoms. Items are scored from 1 to 4 and they are summed to compute a total score ranging from 22 to 88. Higher scores indicate experiencing more symptoms.
Measured: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
The Social Support Scale
Used to investigate the changes in the scores of social support perception. Items are scored from 1 to 5 and they are summed to compute a total score ranging from 20 to 100. higher scores indicate perceived higher social support from family, peer pregnant women, friends, and healthcare providers.
Measured: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
The Maternal-Fetal Attachment Assessment Scale
Used to investigate the changes in the scores of maternal-fetal attachment. Items are scored from 1 to 5 and they are summed to compute a total score ranging from 39 to 195. Higher scores indicate higher maternal-fetal attachment.
Measured: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 May 2012
- Primary completion31 Jan 2015
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tzu Chi University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, WAN-RU WU, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692923
- Sponsor's protocol ID
- TCU
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu WR, Hung CH. Impact of a peer virtual community on pregnant women's well-being: A repeated-measure and quasi-experimental study. J Adv Nurs. 2019 May;75(5):1099-1107. doi: 10.1111/jan.13938. Epub 2019 Jan 24.
PubMed 30575093
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of A Peer Virtual Community on Pregnant Women's Well-being: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT03692923
- Acronym / sponsor ID
- TCU
- Conditions
- Normal Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Tzu Chi UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 2 Oct 2018 (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 study aimed to investigate the effect of exclusive peer-to-peer virtual support on pregnant women's well-being including physical symptoms, depression, social support, maternal attachment, and pregnancy adaptation.
Detailed description
The pregnancy period is marked by not only the joy and excitement of bonding with her baby but also dramatic changes in her body. The Internet's convenience and anonymity provide great possibilities for pregnant women to create a social network for sharing personal stories, seeking information and asking questions, and expressing own emotions and concerns.
Although health-related online communities are emerging rapidly around the globe, little is known about the impact of a virtual peer community on pregnant women's well-being.
The study enrolled 138 pregnant women, who were assigned to either the experimental or control groups. After obtaining informed consent from participants, we asked them to fill out the baseline questionnaires (Time 1). The first and second follow-ups (Times 2 and 3) were conducted at 22-24 and 36-38 weeks of pregnancy, respectively. Participants in the experimental group received ordinary prenatal care in addition to virtual community participation, and those in the control group received only ordinary prenatal care.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –participants received ordinary prenatal care. |
| virtual community group | Experimental | Other: virtual communityparticipants were invited to join a virtual community to interact with peers in addition to their ordinary prenatal care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women were older than 20 years old
- Had at least 9 years of education.
Key exclusion criteria (2 listed)
- Had complications in this pregnancy
- Had underlying medical problems with pregnancy.
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 |
|---|---|---|
| virtual community | Other | virtual community group |
Primary outcome
The pregnancy adaptation scale
Time frame: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
Used to investigate the changes in the scores of pregnancy adaptation. Items are scored from 0 to 3 and they are summed to compute a total score ranging from 0 to 84. Higher scores indicate better pregnancy adaptation.
The Edinburgh Depression Scale
Time frame: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
Used to investigate the changes in the scores of depression. Items are scored from 0 to 3 and they are summed to compute a total score ranging from 0 to 30. The cut-off point for depression is a total score of 12 or above.
3 secondary outcomes
The Symptoms Checklist
Time frame: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
The Social Support Scale
Time frame: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
The Maternal-Fetal Attachment Assessment Scale
Time frame: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Derived from this study: PubMed 30575093Wu WR, Hung CH. Impact of a peer virtual community on pregnant women's well-being: A repeated-measure and quasi-experimental study. J Adv Nurs. 2019 May;75(5):1099-1107. doi: 10.1111/jan.13938. Epub 2019 Jan 24.
- 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 virtual community in people with Normal Pregnancy, run by Tzu Chi 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The pregnancy adaptation scale (time frame: repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).). 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?
On the ClinicalTrials.gov record for NCT03692923, which also lists 1 linked publication.
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 4 Oct 2018.