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

Disorder of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629302
• Other study ID #: EKNZ 2015-153
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 2017

Study information

• Verified date: October 2017
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disease
• Disorder of Consciousness

Intervention

Other:
• animal assisted therapy
physiotherapy, speech therapy and occupational therapy in the presence of an animal
• standard therapy
standard physiotherapy, speech therapy and occupational therapy

Locations

Country	Name	City	State
Switzerland	REHAB Basel	Basel

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Institute for Interdisciplinary Research on the Human-Pet Relationship, Rehab Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of consciousness	assessed via behavioral coding in Noldus Observer	4 weeks
Secondary	Heart rate	assessed via non-invasive HR monitoring belts (Polar® RS800CX, Polar® Electro Oy)	4 weeks
Secondary	Behavioral reaction	measured via therapist's ratings on the BAVESTA scale (Basler Assessment Vegetative State)	4 weeks