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Completed

NCT Number: NCT02629302

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

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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REHAB Basel

Basel, 4012, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

animal assisted therapy

Other

physiotherapy, speech therapy and occupational therapy in the presence of an animal

Standard therapy

Other

standard physiotherapy, speech therapy and occupational therapy

Primary outcomes

  1. Degree of consciousness

    Time frame: 4 weeks

    assessed via behavioral coding in Noldus Observer

Secondary outcomes

  1. Heart rate

    Time frame: 4 weeks

    assessed via non-invasive HR monitoring belts (Polar® RS800CX, Polar® Electro Oy)

  2. Behavioral reaction

    Time frame: 4 weeks

    measured via therapist's ratings on the BAVESTA scale (Basler Assessment Vegetative State)

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • Institute for Interdisciplinary Research on the Human-Pet Relationship
  • Rehab Basel

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 14, 2015
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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