Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT06242717

Conditions

Postpartum Anxiety

Postpartum Depression

Postpartum Disorder

Postoperative Pain

Sleep Wake Disorders

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The goal of this project is to facilitate the design of individualized postpartum anxiety (PPA) screening strategies in British Columbia (BC), Canada. A cohort of postpartum people (n=550) will be invited to complete the following seven questionnaires at 4-8 weeks after delivery:

1. State-Trait Anxiety Inventory
2. Edinburgh Postnatal Depression Scale
3. Multidimensional Scale of Perceived Social Support
4. PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anger, Short Form 5-a
5. Short Form Brief Pain Inventory
6. WHOQOL-BREF for assessing quality of life
7. PROMIS Sleep Disturbance Short Form 8-b and PROMIS Sleep-Related Impairment Short Form 8-a

The investigators will evaluate the feasibility of screening for postpartum anxiety and comorbid conditions through a web-based platform in a diverse BC population. They will assess the usability of the platform and questionnaires through 12-15 follow-up interviews with study participants and responses to the System Usability Scale. Their analysis will also identify patient characteristics and comorbidities (e.g., anger, pain, sleep disturbance) associated with a positive screen for postpartum anxiety.

Conditions

Postpartum Anxiety

Postpartum Depression

Postpartum Disorder

Postoperative Pain

Sleep Wake Disorders

Study ID

NCT06242717

Start date

Nov 9, 2023

Status verified date

Feb, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ≥ 19 years
  • 4-8 weeks postpartum
  • Proficiency to participate in English
  • Delivered within the province of British Columbia, Canada

Exclusion Criteria:

None.

Study Design

Enrollment

550 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Percentage of participants who completed surveys [ Time Frame: 4-8 weeks postpartum ]
  • Proportion of participants who consider usability of online surveys as being excellent (>85) with a System Usability Scale (SUS) [ Time Frame: 4-8 weeks postpartum ]

Central Contacts and Locations

Central contacts

Marianne Vidler, PhD, MSc

604-875-2424marianne.vidler@cw.bc.ca

Locations

BC Women's Hospital & Health Centre

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Marianne Vidler, PhD, MSc

604-875-2424marianne.vidler@cw.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Feb 23, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-02-23.