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Magic Therapy to Relieve Pediatric Patient Anxiety and Improve the Hospitalization Experience

Primary Purpose

Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magic Therapy
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Magic, Anxiety, Pediatric

Eligibility Criteria

5 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Stony Brook UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Magic Therapy Group

Standard Child Life Therapy Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

To determine medical professional opinions regarding magic therapeutic services as offered at Stony Brook Children's Hospital.
Medical professionals will receive a questionnaire adapted from a prior study to assess their opinions regarding magic as a therapeutic intervention in an inpatient setting.

Full Information

First Posted
September 28, 2017
Last Updated
October 6, 2017
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT03308240
Brief Title
Magic Therapy to Relieve Pediatric Patient Anxiety and Improve the Hospitalization Experience
Official Title
Magic Therapy to Relieve Pediatric Patient Anxiety and Improve the Hospitalization Experience
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
July 26, 2018 (Anticipated)
Study Completion Date
July 26, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The use of magic in healthcare has been described across a variety of settings. Several peer-reviewed publications have described the use of magic to help encourage the recovery of motor skills 2. Green et al. reported that after the completion of an intense 2-week magic-theme summer camp, patients with spastic hemiplegia significantly increased the usage of their affected hand 3. Another investigation sought to study if magic could be used to aid in communication with mentally-disabled children 4. This study concluded that magic was effective in building trust, improving the subjects' self-esteem, and enriching their interpersonal skills. Magic has also been partially studied in a surgical context for relieving perioperative anxiety. One study sought to evaluate the efficacy of clowns (whose performance included magic tricks) in relieving perioperative anxiety 5. Patients that were undergoing surgical procedures were placed in either a clown group or non-clown group. These patients were not grouped based on surgical procedures, and patients were included that were undergoing one of ten different surgeries. Anxiety levels of the pediatric patients were measured in the waiting room and induction room immediately prior to anesthesia administration. Additionally, parent state and trait anxiety was measured during their child's induction using the State-Trait Anxiety Inventory (STAI). Health professionals involved in the surgeries were also questioned using a questionnaire developed by the authors to obtain health providers' opinion regarding the presence of clowns as administered in the study. Moreover, clowns filled out a self-evaluation form regarding how they believed their interaction with the child went prior to the surgery. The authors found that the clown group displayed decreased anxiety during anesthesia induction but not in the waiting room. They also documented that health professionals believed the clowns benefitted the child, but at the same time, a majority of the staff discouraged continuance of the program due to interference with operating room procedures. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Magic, Anxiety, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magic Therapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Child Life Therapy Group
Arm Type
No Intervention
Arm Description
Stony Brook Child Life Specialists will provide standard therapies available to all patients, such as pet therapy, art therapy, music therapy.
Intervention Type
Behavioral
Intervention Name(s)
Magic Therapy
Intervention Description
As described in the arm description
Primary Outcome Measure Information:
Title
To assess the therapeutic benefits of magic therapeutic intervention and impact on patient anxiety age 5-13 years.
Description
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.
Time Frame
1-2 days per patient during course of hospitalization
Title
To assess the therapeutic benefits of magic therapeutic intervention and impact on pediatric patient anxiety age 5-16 years.
Description
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.
Time Frame
1-2 days per patient during course of hospitalization
Title
To assess the therapeutic benefits of magic therapeutic intervention and impact on patient (age 5-16) and caregiver anxiety.
Description
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).
Time Frame
1-2 days per patient during course of hospitalization
Secondary Outcome Measure Information:
Title
To determine medical professional opinions regarding magic therapeutic services as offered at Stony Brook Children's Hospital.
Description
Medical professionals will receive a questionnaire adapted from a prior study to assess their opinions regarding magic as a therapeutic intervention in an inpatient setting.
Time Frame
One year, duration of patient/caregiver couplet enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maribeth B Chitkara, MD
Phone
631-444-2648
Email
maribeth.chitkara@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Harrison Pravder, BS
First Name & Middle Initial & Last Name & Degree
David Elkin, BS
First Name & Middle Initial & Last Name & Degree
Amanda Leng-Smith, BS

12. IPD Sharing Statement

Plan to Share IPD
No

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Magic Therapy to Relieve Pediatric Patient Anxiety and Improve the Hospitalization Experience

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