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

Not Applicable

Completed

• Conditions: Disorder of Consciousness
• Interventions: Other: animal assisted therapy; Other: standard therapy

• Registration Number: NCT02629302
• Lead Sponsor: Swiss Tropical & Public Health Institute

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-14
• Study Start: 2016-01
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-10
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
animal assisted therapy	animal assisted therapy	"Standard" therapy (speech therapy, occupational therapy and physiotherapy) that is done in the presence and with Integration of an animal.
standard therapy	standard therapy	standard physiotherapy, standard speech therapy and standard occupational therapy

Primary Outcome Measures

Name	Time	Method
Degree of consciousness	4 weeks	assessed via behavioral coding in Noldus Observer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

REHAB Basel; 🇨🇭 Basel, Switzerland