NCT03171896

Brief Summary

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

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

October 25, 2016

Last Update Submit

May 28, 2017

Conditions

Affective Symptoms

Outcome Measures

Primary Outcomes (1)

  • Mood and satisfaction after labor

    Women will answer questionairs which will be summarized and analyzed

    the day after delivery

Study Arms (2)

Intervention

EXPERIMENTAL

Medical clown

Other: clown

No Intervention

SHAM COMPARATOR

No clown in the room

Other: Sham

Interventions

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

Intervention
ShamOTHER

No clown will be present in the room during labor

No Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnancy, Older than 18 years, Younger than 40 years, uncomplicated pregnancy

You may not qualify if:

  • Pregnancy complicated by PET, premature contractions Muktiple pregnancy, Older than 40 years, Younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Affective Symptoms

Interventions

Laughter Therapysalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

May 31, 2017

Study Start

November 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

With the medical and general public