Breast MilkNCT01758133
Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants
An observational study of Breast Milk, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk
- What is being tested?
- Exposure to medical clown activities
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jul 2013
- Phase
- Observational
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Mothers of premature infants
Who may be able to join
- Nursing mothers of infants born less than 34th week
Who cannot join
- Sick mothers
- Take medication forbidden during nursing
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production.
- Conditions
- Breast Milk
- Being tested
- Exposure to medical clown activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to medical clown activitiesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mothers exposed to medical clowns | Mothers of premature infants who have been exposed to medical clown activities Receives: Behavioral: Exposure to medical clown activities | |
| Mothers not exposed to medical clown activity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of breast milk produced
Mothers who have either been exposed or not exposed to medical clown activities will pump their breast milk. The milk will be measured and the two groups production will be compared.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MilkStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758133
- Sponsor's protocol ID
- 006612-HYMC
- Status last verified
- Dec 2012
- First submitted
- 24 Dec 2012
- Last updated
- 1 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants
- ClinicalTrials.gov ID
- NCT01758133
- Acronym / sponsor ID
- 006612-HYMC
- Conditions
- Breast Milk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 1 Jan 2013 (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.
The aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers exposed to medical clowns | – | Behavioral: Exposure to medical clown activitiesMothers of premature infants who have been exposed to medical clown activities |
| Mothers not exposed to medical clown activity | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Mothers of premature infants
Key inclusion criteria (1 listed)
- Nursing mothers of infants born less than 34th week
Key exclusion criteria (2 listed)
- Sick mothers
- Take medication forbidden during nursing
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 |
|---|---|---|
| Exposure to medical clown activities | Behavioural | Mothers exposed to medical clowns |
Primary outcome
Amount of breast milk produced
Time frame: One week
Mothers who have either been exposed or not exposed to medical clown activities will pump their breast milk. The milk will be measured and the two groups production will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Jan 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramit Magen-Rimon, MD (972-54-3064660, ramit.magen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of breast milk produced (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2013.