NCT03308240

Brief Summary

This study will assess the efficacy of magic therapy services in relieving pediatric patient anxiety and parent anxiety in an inpatient setting. It will also measure family satisfaction with child life services during the hospital visit and health professional opinions regarding such a therapy in an inpatient setting. The primary evaluation method will be through surveys. No prior investigations have studied using magic therapy as a primary tool to improve the psychological well-being of pediatric patients over the span of an inpatient hospitalization. Study and improvement of magic therapy services provides an evidence-based approach to improve pediatric patient psychological well-being, assist physicians in obtaining pediatric patient cooperation with procedures, and improving the hospitalization experience for the family of hospitalized pediatric patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 26, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

September 28, 2017

Last Update Submit

October 6, 2017

Conditions

Keywords

MagicAnxietyPediatric

Outcome Measures

Primary Outcomes (3)

  • To assess the therapeutic benefits of magic therapeutic intervention and impact on patient anxiety age 5-13 years.

    The Venham Picture Test (VPT) will be administed pre- and post-therapies (magic and standard child life therapies) to patients aged 5-13 to measure anxiety levels. The VPT is a measure of childhood state anxiety that has been validated for use in children aged 3-13 (Venham, Bengston, \& Cipes, 1979). It has a series of pictures of faces expressing escalating levels of paint/anxiety.

    1-2 days per patient during course of hospitalization

  • To assess the therapeutic benefits of magic therapeutic intervention and impact on pediatric patient anxiety age 5-16 years.

    The Facial Image Scale will be administered pre- and post-therapies (magic and standard child life services) to children abed 5-16. The Facial Image Scale is a validated too that utilizes a series of five faces depicting faces ranging in expression from very happy to very unhappy (Buchanan \& Niven, 2002). Children are asked at a specific time, which face they feel like at the moment. This scale has been used and validated in children aged 3-18.

    1-2 days per patient during course of hospitalization

  • To assess the therapeutic benefits of magic therapeutic intervention and impact on patient (age 5-16) and caregiver anxiety.

    The 6-item State-Trait Anxiety Inventory (STAI) is a validated tool which will be used to measure anxiety pre- and post-therapies (magic and standard child life therapies) for pediatric patients 5-16 years of age, and for caregivers of patients (Marteau \& Bekker, 1992; Thanh Nhan Nguyen, Nilsson, Hellström, \& Bengtson, 2010). This scale has also been validated in children from age 5-16 (Apell, Paradi, Kokinsky, Nilsson, \& Kokinsky, 2011).

    1-2 days per patient during course of hospitalization

Secondary Outcomes (1)

  • To determine medical professional opinions regarding magic therapeutic services as offered at Stony Brook Children's Hospital.

    One year, duration of patient/caregiver couplet enrollment

Study Arms (2)

Magic Therapy Group

EXPERIMENTAL

Medical student magicians who have completed MagicAid training will provide the therapy. Three or four tricks will be performed per patient at the discretion of the magician to cater to patient age and cognition capabilities. Patients in the experimental group may be given the opportunity to learn a magic trick that has been presented to them as well.

Behavioral: Magic Therapy

Standard Child Life Therapy Group

NO INTERVENTION

Stony Brook Child Life Specialists will provide standard therapies available to all patients, such as pet therapy, art therapy, music therapy.

Interventions

Magic TherapyBEHAVIORAL

As described in the arm description

Magic Therapy Group

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All 5-18 year-old patients that are admitted to the general pediatric inpatient pediatric unit at Stony Brook Children's
  • All Caregivers of patients admitted to the general pediatric inpatient pediatric unit at Stony Brook Children's
  • All medical professionals present on the pediatric inpatient unit at Stony Brook Children's during magic and child life service therapy.

You may not qualify if:

  • Patients/caregivers who are not able to speak/read English
  • Patients under the age of 5 years, as the instruments to be used to measure anxiety have not been validated in this age group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794-8111, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups will be studied: an experimental group (patient and caregiver) receiving one magic therapy session within the hospitalization period and a control group (patient and caregiver) who will receive standard child life therapies.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Pediatrics

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 12, 2017

Study Start

July 26, 2017

Primary Completion

July 26, 2018

Study Completion

July 26, 2018

Last Updated

October 12, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations