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| Sponsors and Collaborators: |
American University of Beirut Medical Center Wellcome Trust |
|---|---|
| Information provided by: | American University of Beirut Medical Center |
| ClinicalTrials.gov Identifier: | NCT00857051 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Stress |
Other: Hotline Service Other: Film |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment |
| Official Title: | Postpartum Support: Can we Facilitate the Transition to Motherhood? |
| Estimated Enrollment: | 552 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
A 22 minute DVD that discusses common stressor in the early postpartum.
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Other: Film
A DVD addressing common stressors in the early postpartum.
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2: Experimental
A 24 hour hotline available for the first 3 months postpartum.
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Other: Hotline Service
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.
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3: Experimental
Both the film and the hotline will be given to this arm.
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Other: Hotline Service
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.
Other: Film
A DVD addressing common stressors in the early postpartum.
|
|
4: No Intervention
A CD of children's music will be given to mothers in this arm.
|
The postpartum period is a very stressful experience for most mothers. It is generally accepted that women are physically and psychologically stressed during the postpartum. After delivery a woman may have worries about the health of her baby and her own health, as well as the changes in her body, their impact on her sexual life and her relationship with her husband. In addition, she may have financial concerns, concerns about breastfeeding, and be worried about bonding with her baby.
First-time mothers also have to adapt to their new role as mothers and may be worried about their abilities to take care of the baby. This may cause first-time mothers to develop postpartum depression and other emotional problems. First-time mothers can feel overwhelmed, exhausted, and isolated in their new roles.
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. The hotline will be answered by a trained midwife.
Women will be recruited from all hospitals in Beirut after delivery and before they leave the hospital. If they agree to participate in the study, they will be randomly assigned to receive the film, the hotline service, both the film and the hotline service, or a CD containing children's songs. Women will be visited at home at 2 - 3 months after delivery by a researcher to complete questionnaires designed to measure stress, depression and anxiety in the postpartum.
Participants will not receive any financial compensation for participating in the study. Although women may benefit from the interventions, we will not know that until we complete the study. However, participation in this study may benefit mothers in the future if we find that the hotline or educational video are useful. There are no risks associated with participation in this study.
Confidentiality of the collected information will be ensured. All information collected will be used for research purposes and will be kept anonymous.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Hibah O Osman, MD, MPH | 961 1 350000 ext 4676 | ho02@aub.edu.lb |
| Contact: Matilda Saliba, MS | 961 1 350000 ext 4667 | ms93@aub.edu.lb |
| Lebanon | |
| American University of Beirut | Recruiting |
| Beirut, Lebanon | |
| Contact: Hibah Osman, MD, MPH 961 1 350000 ext 4676 ho02@aub.edu.lb | |
| Contact: Matilda Saliba, MS 901 1 350000 ext 4667 ms93@aub.edu.lb | |
| Sub-Investigator: Monique Chaaya, PhD | |
| Sub-Investigator: Anwar Nassar, MD | |
| Principal Investigator: | Hibah Osman, MD, MPH | American University of Beirut Medical Center |
More Information
| Responsible Party: | American University of Beirut ( Hibah Osman, MD, MPH ) |
| Study ID Numbers: | FM.HO.04 |
| Study First Received: | March 5, 2009 |
| Last Updated: | March 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00857051 History of Changes |
| Health Authority: | Lebanon: Institutional Review Board |
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Stress |
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Stress |
