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

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

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Other: animal assisted therapy; Other: standard therapy

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4012
    • REHAB Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Rehab Basel; Institute for Interdisciplinary Research on the Human-Pet Relationship
• Investigators: Principal Investigator: Karin Hediger, REHAB Basel

Publications and helpful links

General Publications

• Hediger K, Petignat M, Marti R, Hund-Georgiadis M. Animal-assisted therapy for patients in a minimally conscious state: A randomized two treatment multi-period crossover trial. PLoS One. 2019 Oct 1;14(10):e0222846. doi: 10.1371/journal.pone.0222846. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 14, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: EKNZ 2015-153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED