search
Back to results

The Effects of Dog Intervention on Anxiety Levels in Children Undergoing an MRI Examination (yes)

Primary Purpose

Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Animal Assisted Intervention
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Dog Intervention, MRI, Children

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Animal assisted intervention

    control group

    Arm Description

    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

    The control group will receive the standard training on the imaging process by the MRI technician.

    Outcomes

    Primary Outcome Measures

    Anxiety level
    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

    Secondary Outcome Measures

    Anxiety profile assessment
    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
    Evaluate children experience
    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
    Quality of the 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
    Pulse measurements
    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.

    Full Information

    First Posted
    March 26, 2015
    Last Updated
    April 2, 2015
    Sponsor
    Rambam Health Care Campus
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02411721
    Brief Title
    The Effects of Dog Intervention on Anxiety Levels in Children Undergoing an MRI Examination
    Acronym
    yes
    Official Title
    The Effects of Dog Intervention on Anxiety Levels in Children Undergoing an MRI Examination ; Open Label, Randomized Controlled Trail
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    May 2016 (Anticipated)
    Study Completion Date
    May 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Studies have shown that about two thirds of the children undergoing MRI suffer from feelings of anxiety ranging from mild apprehension to severe distress. Especially in young children, the unfamiliar surroundings, new faces, strange equipment and the noise generated during the scan, can cause feelings of stress and anxiety so severe that the test either cannot be started or cannot be performed properly due to the child's movements. For older children and adults claustrophobia is the main reason of poor image quality because of motion artifacts and/or early termination of the scan. 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 children's anxiety before MRI procedures have been reported. The current study is designed to determine if dog intervention lessens children's anxiety prior to MRI
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety
    Keywords
    Anxiety, Dog Intervention, MRI, Children

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Animal assisted intervention
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The control group will receive the standard training on the imaging process by the MRI technician.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Animal Assisted Intervention
    Intervention Description
    Initial conversation between dog handler and child. The purpose hereof is to let the child express any fear he experiences towards the examination. The presence of the dog allows the child to project his emotions on the dog and to speak more freely about his anxiety. The dog handler informs the child on the various stages of the procedure. For this a booklet has been prepared in which a dog is the patient undergoing an MRI-scan. The child can identify with the dog in the story, and at the same time feel comforted by the dog present. Procession of emotions. The child will play freely with the dog. The purpose hereof is to create a soothing atmosphere. In stroking the soft, friendly animal the child may feel more relaxed and therefore less anxious towards the examination.
    Primary Outcome Measure Information:
    Title
    Anxiety level
    Description
    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
    Time Frame
    immediately after end of intervention
    Secondary Outcome Measure Information:
    Title
    Anxiety profile assessment
    Description
    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
    Time Frame
    up to 10 minutes after MRI scan
    Title
    Evaluate children experience
    Description
    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
    Time Frame
    1 week after the intervention
    Title
    Quality of the MRI scan
    Description
    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
    Time Frame
    up to two weeks after MRI scan
    Title
    Pulse measurements
    Description
    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.
    Time Frame
    Immidiately before and immediately after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anat Ilivitzki, MD
    Phone
    972-4-7773682
    Email
    a_ilivitzki@rambam.health.gov.il

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Dog Intervention on Anxiety Levels in Children Undergoing an MRI Examination

    We'll reach out to this number within 24 hrs