Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness

Study Overview
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Brief Summary
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The study investigates the effects of animal-assisted therapy on patients with severe disorders of consciousness. The focus lies on the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 10 patients during 16 therapy sessions. While half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. In this study, patients in a minimal conscious state are recruited.

Detailed Description
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This pilot study is designed as a controlled cross-over, within-subject trial with repeated measurement. The experimental condition is the standardised therapy session using therapy animals (AAT), while the control condition is the comparable standard therapy session without the presence of an animal. Over a period of four weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 16 therapy sessions (8 experimental, 8 control) for each patient. Each therapy session lasts about 20 minutes. The study takes place at REHAB Basel. Animal-assisted therapies are held in a special room at REHAB Basel in the presence of one or more small animals that will be selected by the therapist. Patients are allocated randomly to start with either the experimental or the control condition.

Official Title
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Effects of Animal-assisted Therapy in Patients With Severe Disorders of Consciousness at REHAB Basel: a Randomised-controlled Trial

Conditions
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Disorder of Consciousness

Intervention / Treatment
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* Other: animal assisted therapy
* Other: standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients of REHAB Basel Disorder of consciousness: minimal conscious state defined via: CRS Score (Coma Remission Scale) of auditory 3-4 or visual 2-5 or motor 3-5 or oromotor/verbal = 3 or communication = 1 BAVESTA Score of 2.8 Exclusion Criteria: Enrolment of the investigator, his/her family members, employees and other dependent persons medical contraindications for contact with animals as allergy, phobia etc. If the patient's medication changes radically during the time of data collection

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: animal assisted therapy<br>Standard therapy (speech therapy, occupational therapy and physiotherapy) that is done in the presence and with Integration of an animal. | Other: animal assisted therapy<br>* physiotherapy, speech therapy and occupational therapy in the presence of an animal<br>|
| Active Comparator: standard therapy<br>standard physiotherapy, standard speech therapy and standard occupational therapy | Other: standard therapy<br>* standard physiotherapy, speech therapy and occupational therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of consciousness | assessed via behavioral coding in Noldus Observer | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | assessed via non-invasive HR monitoring belts (Polar® RS800CX, Polar® Electro Oy) | 4 weeks | 
| Behavioral reaction | measured via therapist's ratings on the BAVESTA scale (Basler Assessment Vegetative State) | 4 weeks |