AnxietyNCT03308240
Magic Therapy to Relieve Pediatric Patient Anxiety and Improve the Hospitalization Experience
A study testing Magic Therapy in people with Anxiety, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Magic Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2017to 26 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794-8111
Maribeth B Chitkara, MD, 631-444-2648, maribeth.chitkara@stonybrookmedicine.edu
Harrison Pravder, BS
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Magic Therapy
- Keywords
- Magic, Anxiety, Pediatric
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magic TherapyBehavioural
As described in the arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
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.
Measured: One year, duration of patient/caregiver couplet enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start26 Jul 2017
- Primary completion26 Jul 2018 (estimated)
- Study completion26 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maribeth Chitkara, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308240
- Sponsor's protocol ID
- 1037793-2
- Status last verified
- Oct 2017
- First submitted
- 28 Sep 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magic Therapy to Relieve Pediatric Patient Anxiety and Improve the Hospitalization Experience
- ClinicalTrials.gov ID
- NCT03308240
- Acronym / sponsor ID
- 1037793-2
- Conditions
- Anxiety
- Keywords
- Magic, Anxiety, Pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 26 Jul 2018 (estimated)
- Study completion
- 26 Jul 2018 (estimated)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magic Therapy Group | Experimental | Behavioral: Magic TherapyMedical 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. |
| 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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magic TherapyAs described in the arm description | Behavioural | Magic Therapy Group |
Primary outcome
To assess the therapeutic benefits of magic therapeutic intervention and impact on patient anxiety age 5-13 years.
Time frame: 1-2 days per patient during course of hospitalization
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.
Time frame: 1-2 days per patient during course of hospitalization
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.
Time frame: 1-2 days per patient during course of hospitalization
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 secondary outcome
To determine medical professional opinions regarding magic therapeutic services as offered at Stony Brook Children's Hospital.
Time frame: One year, duration of patient/caregiver couplet enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stony Brook University
Stony Brook, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magic Therapy in people with Anxiety, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the therapeutic benefits of magic therapeutic intervention and impact on patient anxiety age 5-13 years. (time frame: 1-2 days per patient during course of hospitalization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.