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CompletedNCT02629302Updated May 17, 2018

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

An interventional study of animal assisted therapy and standard therapy in Disorder of Consciousness, sponsored by Swiss Tropical & Public Health Institute. Completed at 1 site in Switzerland. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.

Sponsored by Swiss Tropical & Public Health Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
17 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Disorder of Consciousness
03

In context

Consciousness Disorders

236 studies on the registry are indexed under Consciousness Disorders; 101 are open to participants now.

This study's enrollment of 10 is below the median of 42 across 146 interventional studies indexed under Consciousness Disorders.

Browse Consciousness Disorders studies →

Lead sponsor

Swiss Tropical & Public Health Institute is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

  • Active comparator
    standard therapy

    standard physiotherapy, standard speech therapy and standard occupational therapy

    Other: standard therapy

Interventions

  • Otheranimal assisted therapy

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

  • Otherstandard therapy

    standard physiotherapy, speech therapy and occupational therapy

06

What researchers measure

Primary outcomes

  1. Degree of consciousness

    assessed via behavioral coding in Noldus Observer

    Time frame: 4 weeks

Secondary outcomes

  1. Heart rate

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

    Time frame: 4 weeks

  2. Behavioral reaction

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

    Time frame: 4 weeks

07

Study locations

1 site
  • REHAB Basel
    Basel, 4012, Switzerland
08

References and documents

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. PubMed 31574106 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02629302
Lead sponsor
Swiss Tropical & Public Health Institute
Collaborators
Institute for Interdisciplinary Research on the Human-Pet Relationship, Rehab Basel
Responsible party
Sponsor
First posted
Dec 14, 2015
Start date
Jan 2016
Primary completion
Apr 2017
Completion
Apr 2017
Last update
May 17, 2018

Study contacts

Karin Hediger
principal investigator · Rehab Basel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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