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

NCT ID: NCT02629302

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-04-30

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.

Conditions

Disorder of Consciousness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

animal assisted therapy

"Standard" therapy (speech therapy, occupational therapy and physiotherapy) that is done in the presence and with Integration of an animal.

Group Type: EXPERIMENTAL

animal assisted therapy

Intervention Type: OTHER

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

standard therapy

standard physiotherapy, standard speech therapy and standard occupational therapy

Group Type: ACTIVE_COMPARATOR

standard therapy

Intervention Type: OTHER

standard physiotherapy, speech therapy and occupational therapy

Interventions

animal assisted therapy

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

Intervention Type: OTHER

standard therapy

standard physiotherapy, speech therapy and occupational therapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Interdisciplinary Research on the Human-Pet Relationship

OTHER

Sponsor Role: collaborator

Rehab Basel

OTHER

Sponsor Role: collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Hediger

Role: PRINCIPAL_INVESTIGATOR

Rehab Basel

Locations

REHAB Basel

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 31574106 (View on PubMed)

Other Identifiers

EKNZ 2015-153

Identifier Type: -

Identifier Source: org_study_id