Back to resultsEffect of the Involvement of a Medical Clown on the Labor Experience (LaborClown)
Primary Purpose
Affective Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
clown
Sham
Sponsored by
About this trial
This is an interventional supportive care trial for Affective Symptoms
Eligibility Criteria
Inclusion Criteria:
Singleton pregnancy, Older than 18 years, Younger than 40 years, uncomplicated pregnancy
Exclusion Criteria:
Pregnancy complicated by PET, premature contractions Muktiple pregnancy, Older than 40 years, Younger than 18 years
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention
No Intervention
Arm Description
Medical clown
No clown in the room
Outcomes
Primary Outcome Measures
Mood and satisfaction after labor
Women will answer questionairs which will be summarized and analyzed
Secondary Outcome Measures
Full Information
NCT ID
NCT03171896
First Posted
October 25, 2016
Last Updated
May 28, 2017
Sponsor
The Baruch Padeh Medical Center, Poriya
1. Study Identification
Unique Protocol Identification Number
NCT03171896
Brief Title
Effect of the Involvement of a Medical Clown on the Labor Experience
Acronym
LaborClown
Official Title
Effect of the Involvement of a Medical Clown on the Labor Experience
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Baruch Padeh Medical Center, Poriya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Affective Symptoms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Medical clown
Arm Title
No Intervention
Arm Type
Sham Comparator
Arm Description
No clown in the room
Intervention Type
Other
Intervention Name(s)
clown
Intervention Description
A medical clown will be offerred to the parturient and will spend time with her during labor as long as she will want it
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
No clown will be present in the room during labor
Primary Outcome Measure Information:
Title
Mood and satisfaction after labor
Description
Women will answer questionairs which will be summarized and analyzed
Time Frame
the day after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Singleton pregnancy, Older than 18 years, Younger than 40 years, uncomplicated pregnancy
Exclusion Criteria:
Pregnancy complicated by PET, premature contractions Muktiple pregnancy, Older than 40 years, Younger than 18 years
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
With the medical and general public
Learn more about this trial
Effect of the Involvement of a Medical Clown on the Labor Experience
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