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

NCT02411721 | Unknown

• 1 other identifier: 0530-14-RMB CTIL
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anxiety

Keywords

Anxiety; Dog Intervention; MRI; Children

Outcome Measures

Primary Outcomes (1)

• 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

  immediately after end of intervention

Secondary Outcomes (4)

• Anxiety profile assessment

  up to 10 minutes after MRI scan

• Evaluate children experience

  1 week after the intervention

• Quality of the MRI scan

  up to two weeks after MRI scan

• Pulse measurements

  Immidiately before and immediately after the intervention

Study Arms (2)

Animal assisted intervention

EXPERIMENTAL

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

Behavioral: Animal Assisted Intervention

control group

NO INTERVENTION

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

Interventions

Animal Assisted Intervention BEHAVIORAL

1. 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. 2. 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. 3. 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.

Animal assisted intervention

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• immunocompetent children
• aged 7 to 15 years
• undergoing MRI procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Anat Ilivitzki, MD

CONTACT

972-4-7773682; a_ilivitzki@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 8, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 8, 2015

Record last verified: 2015-04