NCT00857051

Brief Summary

We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
552

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 25, 2009

Status Verified

March 1, 2009

Enrollment Period

4 months

First QC Date

March 5, 2009

Last Update Submit

September 24, 2009

Conditions

Keywords

Stress

Outcome Measures

Primary Outcomes (1)

  • Stress as measure by the Cohen Perceived Stress Scale (PSS-10)

    2 - 3 months

Secondary Outcomes (2)

  • Depression

    2 - 3 months

  • Anxiety

    2 - 3 months

Study Arms (4)

1

EXPERIMENTAL

A 22 minute DVD that discusses common stressor in the early postpartum.

Other: Film

2

EXPERIMENTAL

A 24 hour hotline available for the first 3 months postpartum.

Other: Hotline Service

3

EXPERIMENTAL

Both the film and the hotline will be given to this arm.

Other: Hotline ServiceOther: Film

4

NO INTERVENTION

A CD of children's music will be given to mothers in this arm.

Interventions

A 24 hour hotline to answer questions about baby care or mother self-care. Hotline will be answered by a midwife and answers will be based on algorithms.

23
FilmOTHER

A DVD addressing common stressors in the early postpartum.

13

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy first-time mothers with singleton baby delivered at term with no complications.

You may not qualify if:

  • Mothers with chronic health problems,
  • Pregnancy complications, OR
  • Infants with congenital problems or conditions requiring admission to the intensive care nursery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

Related Publications (2)

  • Osman H, Saliba M, Chaaya M, Naasan G. Interventions to reduce postpartum stress in first-time mothers: a randomized-controlled trial. BMC Womens Health. 2014 Oct 15;14:125. doi: 10.1186/1472-6874-14-125.

  • Hamade H, Chaaya M, Saliba M, Chaaban R, Osman H. Determinants of exclusive breastfeeding in an urban population of primiparas in Lebanon: a cross-sectional study. BMC Public Health. 2013 Jul 31;13:702. doi: 10.1186/1471-2458-13-702.

MeSH Terms

Interventions

Motion Pictures

Intervention Hierarchy (Ancestors)

Audiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Hibah Osman, MD, MPH

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

September 25, 2009

Record last verified: 2009-03

Locations