Effect of the Involvement of a Medical Clown on the Labor Experience (LaborClown)

The experience of labor for a woman can be rewarding but can be traumatic. Medical clowning may alleviate the potential for trauma.

Study Overview

• Status: Unknown
• Conditions: Affective Symptoms
• Intervention / Treatment: Other: clown; Other: Sham

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Medical clown	Other: clown; A medical clown will be offerred to the parturient and will spend time with her during labor as long as she will want it
Sham Comparator: No Intervention; No clown in the room	Other: Sham; No clown will be present in the room during labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood and satisfaction after labor	Women will answer questionairs which will be summarized and analyzed	the day after delivery

Collaborators and Investigators

• Sponsor: The Baruch Padeh Medical Center, Poriya

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: May 28, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 28, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Affective Symptoms
• Other Study ID Numbers: baruchPMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: With the medical and general public

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No