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Clinical Trials/NCT02629302
NCT02629302
Completed
N/A

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

Swiss Tropical & Public Health Institute1 site in 1 country10 target enrollmentJanuary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Disorder of Consciousness
Sponsor
Swiss Tropical & Public Health Institute
Enrollment
10
Locations
1
Primary Endpoint
Degree of consciousness
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
April 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Degree of consciousness

Time Frame: 4 weeks

assessed via behavioral coding in Noldus Observer

Secondary Outcomes

  • Heart rate(4 weeks)
  • Behavioral reaction(4 weeks)

Study Sites (1)

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