- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02411721
The Effects of Dog Intervention on Anxiety Levels in Children Undergoing an MRI Examination (yes)
The Effects of Dog Intervention on Anxiety Levels in Children Undergoing an MRI Examination ; Open Label, Randomized Controlled Trail
Study Overview
Detailed Description
MRI is an imaging method common worldwide, both for adults and children. Studies show, however, that about two thirds of the children undergoing MRI suffer from feelings of anxiety ranging from mild apprehension to severe distress. For very young children, the unfamiliar surroundings, new faces, strange equipment and particularly the noise generated during the scan, can all cause feelings of stress and anxiety so severe that the test either cannot even begin or cannot be performed properly because the child is incapable of lying still. For older children and adults claustrophobia is the main reason of poor image quality because of motion artifacts or early termination of the scan.
Anxiety is a reaction to an unfamiliar situation and its strength is far greater than the objective danger. Anxiety is characterized by subjective feelings of stress and worry that activate the autonomic nervous system.
In recent years, more and more use is made of certain techniques to prepare patients for a wide range of treatments, including methods of preparing patients for the MRI procedure, especially children. The purpose of preparation is to familiarize patients with the equipment and the stages of the imaging procedure. It also enables the technician to answer questions the patient may have and thereby avoid false assumptions about the procedure.
Intervention with animals, dogs in particular, is developing around the world and is being used in a variety of activities in rehabilitation centers, nursing homes, special education schools, hospitals and more.
In 1987 the National Institutes of Health (NIH) recognized the field of animal therapy and during the last two decades many reports have been published on the positive effects when patients interact with animals. These reports include: performance improvements, improved physiological measurements, reduction of stress and anxiety, reduced feelings of loneliness and depression, and a more speedy recovery.The animal is seen as a "friend" in the strange world of the clinic. Having a companion dog present distracts the patient from the surroundings and procedures.
In a pilot study, conducted in 2001 at the New Jersey hospital, an intervention program with a dog was introduced for reducing anxiety in adults before an MRI. This study has demonstrated that animal-assisted intervention indeed decreases the anxiety levels of patients in a pre MRI setting.
Several studies have demonstrated the potential calming effects of companion animals on children but, to date, no formal studies on the relationship between dog intervention and a child's anxiety before an MRI procedure have been reported. The current study is designed to determine if dog intervention lessens children's anxiety prior to MRI.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anat Ilivitzki, MD
- Phone Number: 972-4-7773682
- Email: a_ilivitzki@rambam.health.gov.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- immunocompetent children
- aged 7 to 15 years
- undergoing MRI procedures
Exclusion Criteria:
- allergy or fear of dogs
- previous Animal Assisted Invention (AAI) experience
- immunodeficiency
- asthma
- airway allergies
- open wounds
- infectious diseases that can be transferred by direct and indirect contact
- known aggressiveness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Animal assisted intervention
The Effects of Dog Intervention on Anxiety Levels in Children.
The experimental group will receive standard training on the imaging process by the MRI technician plus intervention activity with a dog
|
|
No Intervention: control group
The control group will receive the standard training on the imaging process by the MRI technician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety level
Time Frame: immediately after end of intervention
|
To determine if among children in the experimental group the anxiety level is reduced in comparison to that of children in the control group.
The State Trait Anxiety Inventory for Children (STAIC) will be used to measure the levels of anxiety of the children after the intervention / waiting period
|
immediately after end of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety profile assessment
Time Frame: up to 10 minutes after MRI scan
|
To determine if, according to the assessment of the medical staff, children in the experimental group are more relaxed during the scan than children in the control group.
The anxiety profile assessment will be filled out by the MRI technician who accompanies the child during the exam.
The technician will be requested to rate on a scale from 1-10 the level of anxiety, the level of stress, and the state of mind of the child
|
up to 10 minutes after MRI scan
|
Evaluate children experience
Time Frame: 1 week after the intervention
|
To determine if one week after having undergone the scan children in the experimental group find the experience less stressful than children in the control group.
A telephone questionnaire with the children will be conducted a week after the procedure in order to evaluate their experience
|
1 week after the intervention
|
Quality of the MRI scan
Time Frame: up to two weeks after MRI scan
|
To determine whether the quality of the MRI scan proves better in children in the experimental group than in children in the control group.
The quality of the simulation test will be determined by the MRI physician.
The criteria that will be used for determining the quality of the test are: motion artifacts and the need for repetition of the protocol due to the child's movements
|
up to two weeks after MRI scan
|
Pulse measurements
Time Frame: Immidiately before and immediately after the intervention
|
To determine if pulse rates of children in the experimental group decrease compared to those of children in the control group.
Pulse measurements will be taken before and after dog intervention / waiting period.
|
Immidiately before and immediately after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0530-14-RMB CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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