StressNCT00857051
Postpartum Support: Can we Facilitate the Transition to Motherhood?
A study testing Hotline Service and Film in people with Stress, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stress
- What is being tested?
- Hotline Service and Film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteLebanon
- Study dates
- Mar 2009to Jul 2009
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy first-time mothers with singleton baby delivered at term with no complications.
Who cannot join
- Mothers with chronic health problems,
- Pregnancy complications, OR
- Infants with congenital problems or conditions requiring admission to the intensive care nursery.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Stress
- Being tested
- Hotline Service, Film
- Keywords
- Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hotline ServiceOther
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.
FilmOther
A DVD addressing common stressors in the early postpartum.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A 22 minute DVD that discusses common stressor in the early postpartum. Receives: Other: Film |
| 2 | Experimental | A 24 hour hotline available for the first 3 months postpartum. Receives: Other: Hotline Service |
| 3 | Experimental | Both the film and the hotline will be given to this arm. Receives: Other: Hotline Service; Other: Film |
| 4 | No intervention | A CD of children's music will be given to mothers in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress as measure by the Cohen Perceived Stress Scale (PSS-10)
Measured: 2 - 3 months
Secondary outcomes (2)
Depression
Measured: 2 - 3 months
Anxiety
Measured: 2 - 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Investigators
- Hibah Osman, MD, MPH, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857051
- Sponsor's protocol ID
- FM.HO.04
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25315167Hamade 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.
PubMed 23902627
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Support: Can we Facilitate the Transition to Motherhood?
- ClinicalTrials.gov ID
- NCT00857051
- Acronym / sponsor ID
- FM.HO.04
- Conditions
- Stress
- Keywords
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Mar 2009 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: FilmA 22 minute DVD that discusses common stressor in the early postpartum. |
| 2 | Experimental | Other: Hotline ServiceA 24 hour hotline available for the first 3 months postpartum. |
| 3 | Experimental | Other: Hotline Service, Other: FilmBoth the film and the hotline will be given to this arm. |
| 4 | No intervention | –A CD of children's music will be given to mothers in this arm. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy first-time mothers with singleton baby delivered at term with no complications.
Key exclusion criteria (3 listed)
- Mothers with chronic health problems,
- Pregnancy complications, OR
- Infants with congenital problems or conditions requiring admission to the intensive care nursery.
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 |
|---|---|---|
| Hotline ServiceA 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 | 2, 3 |
| FilmA DVD addressing common stressors in the early postpartum. | Other | 1, 3 |
Primary outcome
Stress as measure by the Cohen Perceived Stress Scale (PSS-10)
Time frame: 2 - 3 months
2 secondary outcomes
Depression
Time frame: 2 - 3 months
Anxiety
Time frame: 2 - 3 months
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 25 Sep 2009.
- Derived from this study: PubMed 25315167Osman 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.
- Derived from this study: PubMed 23902627Hamade 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.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Hibah Osman, MD, MPH principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hotline Service and Film in people with Stress, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 1 inclusion and 3 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 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Stress as measure by the Cohen Perceived Stress Scale (PSS-10) (time frame: 2 - 3 months). 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 NCT00857051, which also lists 2 linked publications.
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 25 Sep 2009.