Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Medical Clowning During Labor (MedClown)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03167567
Recruitment Status : Unknown
Verified May 2017 by Izhar Ben Shlomo, The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Izhar Ben Shlomo, The Baruch Padeh Medical Center, Poriya

Brief Summary:
Women during their first labor will be offered the assistance of a medical clown. Their experience will be compared after delivery with that of primiparae who were not helped by a medical clown.

Condition or disease Intervention/treatment Phase
Mental Status Change Labor Pain Behavioral: Presence of a medical clown during labor Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Women who will agree to be escorted by a medical clown during their first labor will be interviewed after delivery regarding their experience. Their answers will be compared to those of women whe were not escorted by a clown.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Medical Clowning on Primipara Women During Labor
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: intervention
These women will have a medical clown present in the room during their labor
Behavioral: Presence of a medical clown during labor
Presence of a medical clown during labor

No Intervention: Control
These women will not have a medical clown in the room during their labor



Primary Outcome Measures :
  1. Mood and recollection of experience [ Time Frame: Women will be interviewed within the immediate 48 hours post partum ]
    Structered interview



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All planned vaginal first delivery
  • Older than 18 years
  • Younger than 40 years
  • Mentally healthy

Exclusion Criteria:

  • Previous known mental disorder
  • Younger than 18 years
  • Older than 40 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167567


Contacts
Layout table for location contacts
Contact: Izhar Ben Shlomo, MD 972-52-6124781 ibenshlomo@poria.health.gov.il
Contact: Presilla Rahav, RN, BSc 972-4-6652288 prahav@poria.health.gov.il

Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Investigators
Layout table for investigator information
Study Chair: Odelia Katz, PhD CEO Research Authority

Layout table for additonal information
Responsible Party: Izhar Ben Shlomo, Professor, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier: NCT03167567    
Other Study ID Numbers: 0081-15-POR
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms