NCT03167567

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

12 months

First QC Date

May 23, 2017

Last Update Submit

May 24, 2017

Conditions

Mental Status ChangeLabor Pain

Outcome Measures

Primary Outcomes (1)

  • Mood and recollection of experience

    Structered interview

    Women will be interviewed within the immediate 48 hours post partum

Study Arms (2)

intervention

EXPERIMENTAL

These women will have a medical clown present in the room during their labor

Behavioral: Presence of a medical clown during labor

Control

NO INTERVENTION

These women will not have a medical clown in the room during their labor

Interventions

Presence of a medical clown during laborBEHAVIORAL

Presence of a medical clown during labor

intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Odelia Katz, PhD

    CEO Research Authority

    STUDY CHAIR

Central Study Contacts

Izhar Ben Shlomo, MD

CONTACT

972-52-6124781ibenshlomo@poria.health.gov.il

Presilla Rahav, RN, BSc

CONTACT

972-4-6652288prahav@poria.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 30, 2017

Study Start

July 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share