The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.

NCT ID: NCT01622218

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of our study to quantitatively examine the stress levels prior to surgery and the use of analgesics post surgery in both children and their parents following a preoperative intervention with a medical clown compared to children that were not exposed to this intervention.

Detailed Description

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Conditions

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Umbilical Hernia Inguinal Hernia

Keywords

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Medical clown

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Medical Clown

Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers.

Group Type EXPERIMENTAL

Medical Clown

Intervention Type BEHAVIORAL

Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers

Control

Assessment of child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect on the total consumption of analgesics and on the post- surgery inflammatory markers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Medical Clown

Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* ages 4-10 years old
* undergoing elective umbilical or inguinal hernia repair surgery
* ASA Physical Status = 1

Exclusion Criteria

* None
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Nitza Heiman Newman, MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status

Assuta Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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sor007112clit

Identifier Type: -

Identifier Source: org_study_id