NCT03692923

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

September 21, 2018

Last Update Submit

October 2, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).

  • The Social Support Scale

    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

    repeated measured at second trimester (22-24 weeks of pregnancy), and the third trimester (36-38 weeks of pregnancy).

Study Arms (2)

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.

Other: virtual community

Interventions

virtual community group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women were older than 20 years old
  • Had at least 9 years of education.

You may not qualify if:

  • Had complications in this pregnancy
  • Had underlying medical problems with pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 21, 2018

First Posted

October 2, 2018

Study Start

May 1, 2012

Primary Completion

January 31, 2015

Study Completion

January 31, 2015

Last Updated

October 4, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share