The role of dog-assisted therapy in rehabilitation, clinical recovery and improving quality of life
| ISRCTN | ISRCTN10208787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10208787 |
| Secondary identifying numbers | 183/2019 |
- Submission date
- 14/03/2022
- Registration date
- 15/03/2022
- Last edited
- 13/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Any neuromusculoskeletal illness (affecting the nervous system, muscles or skeleton) means a significant burden for the patient, including reduced quality of life. Animal-assisted therapy may be helpful in the rehabilitation process and in the treatment of patients. The aim of this study is to demonstrate the potential place and relevance of dog-assisted therapy in rehabilitation medicine and to confirm that therapy with dogs reduces patients' anxiety and pain, improves their quality of life, and advances their complex rehabilitation.
Who can participate?
Patients aged 18 years and over with neurological and musculoskeletal disorders (e.g. stroke, multiple sclerosis, arthrosis, amputation, bone fractures)
What does the study involve?
Patients in both the intervention group and the control group receive the same overall amount of therapy sessions, with an average of 2-3 hours of therapy per day. In the intervention group one physical therapy session is replaced with a dog therapy session, where patients receive the same training exercise but are assisted by a therapy dog.
What are the possible benefits and risks of participating?
Possible benefits are promoting rehabilitation and improving health and quality of life. A possible risk is dog hair allergy.
Where is the study run from?
South-Pest Central Hospital National Institute of Haematology and Infectology, Center for Rehabilitation (Hungary)
When is the study starting and how long is it expected to run for?
September 2018 to May 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Veronika Mittly
mittly.veronika@dpckorhaz.hu
Contact information
Scientific
Jahn Ferenc Street 62-66
Budapest
1196
Hungary
 ORCID ID |
0000-0003-1670-2501 |
|---|---|
| Phone | +36 (0)202102530 |
| mittly.veronika@dpckorhaz.hu |
Study information
| Study design | Prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Dog-assisted rehabilitation: the role of animal-assisted therapy in clinical recovery and improving quality of life: a randomized controlled trial |
| Study objectives | The aim of this research is to demonstrate the potential place and relevance of dog-assisted therapy as an adjuvant treatment in rehabilitation medicine and to confirm that therapy with dogs reduces patients' anxiety and pain, improves their quality of life, and advances their complex rehabilitation. |
| Ethics approval(s) | Approved 29/10/2019, Hungarian Medical Research Council (Széchenyi István Square 7-8, Budapest, 1051, Hungary; +36 (0)1 795 1197; tukeb@emmi.gov.hu), ref: 183/2019 |
| Health condition(s) or problem(s) studied | Quality of life of patients with neurological and musculoskeletal disorders |
| Intervention | Group dog therapy sessions are introduced once a week at South-Pest Central Hospital National Institute of Haematology and Infectology, Center for Rehabilitation, in Budapest, Hungary, with a trained therapy dog and a therapy dog handler. Groups have a maximum of five participants at a time, with two groups per week for 3 weeks for each group. The dog is a 5-year-old wire-haired Hungarian Vizsla. Patients who wished to participate in the study are randomized by a random number generator to an intervention or active control group. Patients in both the intervention group and the control group receive the same overall amount of therapy sessions, with an average of 2-3 hours of therapy per day. The concept is to replace one physical therapy session in the intervention group with a dog therapy session, where patients receive the same training exercise but are assisted by a therapy dog. During the intervention group therapy, reflecting the group composition, the research group work with the therapy dog handler to set up tasks aimed at improving motor coordination and endurance, improving fine motor skills of the hands, mobilizing joints, improving balance, developing memory, reducing attention deficit, creating peer support, reducing symptoms of anxiety and depression, and building and utilizing group cohesiveness. A questionnaire pack is completed with the subjects at baseline and after the 3-week program. The researchers use a self-compiled questionnaire on sociodemographic data such as age, residence, marital status, highest level of education, lifestyle factors such as activity, coping strategies and disease-specific information such as diagnosis, time since diagnosis, and co-morbidities. In addition, the Beck Depression Inventory (BDI-9) is used to measure depression, the Spielberger State Anxiety Inventory (STAI) to define the rate of anxiety, the WHO Well-Being Index (WBI) to find out about quality of life, the Illness Intrusiveness Rating Scale (IIRS) to rate general condition and the impact of the therapy received on different aspects of life, as well as the Visual Analogue Scale (VAS) to measure pain. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Anxiety measured using the Spielberger State Anxiety Inventory (STAI) at baseline and after the last, third therapy session 2. Quality of life measured using the WHO Well-Being Index (WBI) at baseline and after the last, third therapy session 3. General condition and the impact of the therapy on different aspects of life measured using the Illness Intrusiveness Rating Scale (IIRS) at baseline and after the last, third therapy session |
| Secondary outcome measures | 1. Depression measured using the Beck Depression Inventory (BDI-9) at baseline and after the last, third therapy session. 2. Pain measured using the Visual Analogue Scale (VAS) at baseline and after the last, third therapy session |
| Overall study start date | 01/09/2018 |
| Completion date | 31/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Total final enrolment | 118 |
| Key inclusion criteria | Patients aged 18 years and over with neurological and musculoskeletal disorders (e.g. stroke, multiple sclerosis, arthrosis, amputation, bone fractures) |
| Key exclusion criteria | 1. Dog hair allergy 2. Immunosuppressed status 3. Early postoperative status 4. Age less than 18 years 4. Dementia 5. Refusal to participate in research 6. Decompensated physical and psychological status determined by the treating physician |
| Date of first enrolment | 01/10/2019 |
| Date of final enrolment | 15/03/2020 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Jahn Ferenc Street 62-66
Budapest
1196
Hungary
Sponsor information
University/education
Üllői Street 26
Budapest
1086
Hungary
| Phone | +36 (0)12102930 |
|---|---|
| titkarsag.magatartastudomany@semmelweis-univ.hu | |
| Website | http://semmelweis.hu/english/the-university/ |
"ROR" |
https://ror.org/01g9ty582 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Veronika Mittly (mittly.veronika@dpckorhaz.hu) should be contacted for access to the dataset. Data will be shared for scientific purposes, e.g. meta-analysis, and raw data will be sent by email upon request. Data will be released at the request of members of any research team. The dataset contains sensitive data, patients are anonymised so that they cannot be identified. The database includes patient code, age, sex, level of education, marital status, diagnosis, co-morbidities and their answers to questionnaires at baseline and after the last, third therapy session. Informed, written consent of participants for data sharing is available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/06/2024 | 13/06/2024 | Yes | No |
Editorial Notes
13/06/2024: Publication reference added.
15/03/2022: Trial's existence confirmed by the Hungarian Medical Research Council.
