Affective SymptomsLaborClownNCT03171896
Effect of the Involvement of a Medical Clown on the Labor Experience
A study testing clown in people with Affective Symptoms, run by The Baruch Padeh Medical Center, Poriya.
Trial summary
The experience of labor for a woman can be rewarding but can be traumatic. Medical clowning may alleviate the potential for trauma. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Affective Symptoms
- What is being tested?
- clown
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to Dec 2018
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton pregnancy, Older than 18 years, Younger than 40 years, uncomplicated pregnancy
Who cannot join
- Pregnancy complicated by PET, premature contractions Muktiple pregnancy, Older than 40 years, Younger than 18 years
About this study
The experience of labor for a woman can be rewarding but can be traumatic. Medical clowning may alleviate the potential for trauma.
Read the detailed description
The investigators plan to administer questionnaires to women who will agree to host a clown during their labor and to compare the feedback to those from women who did not.
- Conditions
- Affective Symptoms
- Being tested
- clown, Sham
- Medical subject headings
- Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clownOther
A medical clown will be offerred to the parturient and will spend time with her during labor as long as she will want it
ShamOther
No clown will be present in the room during labor
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Medical clown Receives: Other: clown |
| No Intervention | Sham comparator | No clown in the room Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood and satisfaction after labor
Women will answer questionairs which will be summarized and analyzed
Measured: the day after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Nov 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affective SymptomsStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171896
- Sponsor's protocol ID
- baruchPMC
- Acronym
- LaborClown
- Status last verified
- May 2017
- First submitted
- 25 Oct 2016
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With the medical and general public
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Involvement of a Medical Clown on the Labor Experience
- ClinicalTrials.gov ID
- NCT03171896
- Acronym / sponsor ID
- LaborClown / baruchPMC
- Conditions
- Affective Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 May 2017 (actual)
- 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 experience of labor for a woman can be rewarding but can be traumatic. Medical clowning may alleviate the potential for trauma.
Detailed description
The investigators plan to administer questionnaires to women who will agree to host a clown during their labor and to compare the feedback to those from women who did not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: clownMedical clown |
| No Intervention | Sham comparator | Other: ShamNo clown in the room |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Singleton pregnancy, Older than 18 years, Younger than 40 years, uncomplicated pregnancy
Key exclusion criteria (1 listed)
- Pregnancy complicated by PET, premature contractions Muktiple pregnancy, Older than 40 years, Younger than 18 years
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 |
|---|---|---|
| clownA medical clown will be offerred to the parturient and will spend time with her during labor as long as she will want it | Other | Intervention |
| ShamNo clown will be present in the room during labor | Other | No Intervention |
Primary outcome
Mood and satisfaction after labor
Time frame: the day after delivery
Women will answer questionairs which will be summarized and analyzed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: Yes. With the medical and general public
Related trials for Affective Symptoms
Enrolling by invitation
Visuospatial and Affective Abilities in Parkinson Disease
Parkinson Disease, Alexithymia
Recruiting
Neural and Psychological Mechanisms of Pain Perception
Pain, Normal Physiology
Recruiting
Pilot Trial for Health Products on Mood and Sleep Quality
Sleep Disturbance, Emotional Disturbance
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Enrolling by invitationObservational study
Studio TIARA: Alessitimia ed Emicrania Cronica
Migraine, Alexithymia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing clown in people with Affective Symptoms, run by The Baruch Padeh Medical Center, Poriya.
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 1 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
Mood and satisfaction after labor (time frame: the day after delivery). 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 31 May 2017.