Clinical Trial: Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Swiss Tropical & Public Health Institute

Current Primary Outcome: Degree of consciousness [ Time Frame: 4 weeks ]

assessed via behavioral coding


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Heart rate [ Time Frame: 4 weeks ]
    assessed via EKG (Polar)
  • reaction ability [ Time Frame: 4 weeks ]
    measured via therapist's ratings on the BAVESTA scale (Basler Assessment Vegetative State)


Original Secondary Outcome:

  • Heart rate [ Time Frame: 4 weeks ]
    assessed via EKG (Polar)
  • reaction ability [ Time Frame: 4 weeks ]
    measured via therapist's ratings on the BAVESTA scale


Information By: Swiss Tropical & Public Health Institute

Dates:
Date Received: December 7, 2015
Date Started: January 2016
Date Completion: July 2017
Last Updated: October 7, 2016
Last Verified: October 2016