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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05100108
Other study ID # AAI_Teachers
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 26, 2021
Est. completion date December 23, 2021

Study information

Verified date October 2021
Source King Juan Carlos University
Contact Daniel Collado-Mateo, PhD
Phone +34 914 88 75 18
Email daniel.collado@urjc.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controlled trial aims to evaluate the effects of an 8-week program consisting of dog-assisted therapy on the work engagement, burnout, pain, and quality of life among professionals working in a School for Special Education. A total of 30 participants will be involved in the program, which will be comprised of eight 50-min sessions conducted once a week. The hypothesis of the researchers in this study is that this program will achieve a reduction in burnout levels in workers, as well as an improvement in engagement and quality of life.


Description:

Animal-assisted interventions have shown numerous benefits in different populations including children with cerebral palsy or autism spectrum disorder, people with chronic pain, older adults, or people in prison. Recently, different initiatives have been carried out focused on improving the work environment, especially among professionals in clinical settings and obtaining benefits in mood, as well as a reduction in the levels of stress and burnout of employees. In addition, it has also been observed that these animals in the workplace can produce an improvement in health, productivity or job satisfaction. The presence of stress or anxiety among professionals working in Special Education Schools has been previously reported and could increase burnout and reduce the engagement and health-related quality of life of these workers. Therefore, the current randomized controlled trial aims to evaluate the effects of an 8-week program consisting of dog-assisted therapy on the work engagement, burnout, pain, and quality of life among professionals working in a School for Special Education. A total of 30 participants will be involved in the program, which will be comprised of eight 50-min sessions conducted once a week. The hypothesis of the researchers is that this program will achieve a reduction in burnout levels in workers, as well as an improvement in engagement and quality of life.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 23, 2021
Est. primary completion date December 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - be aged >18 years - be workers in a School for Special Education - work in direct contact with children (teachers, physiotherapists, etc.) Exclusion Criteria: - People with dog-allergy - People with dog phobia - People with a history of impulsive animal aggression

Study Design


Intervention

Behavioral:
Dog-assisted therapy
The program will involve 8 sessions, conducted once a week for 8 weeks. Each session will include three parts: 1) a welcome part aimed to get in touch with the dog, 2) a main part, where participants will be taught basic notions about dog training and then try to train the dogs. In this part, the patients will perform different activities and exercises with the dog. 3) A closing part to relaxation and say goodbye to the dogs.

Locations

Country Name City State
Spain King Juan Carlos University Móstoles Madrid

Sponsors (2)

Lead Sponsor Collaborator
Daniel Collado-Mateo Asociación Dame La Pata

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Burnout levels assessed using the Burnout Clinical Subtypes Questionnaire The Burnout Clinical Subtypes Questionnaire (BCSQ-36) evaluates by means of 36 items the burnout of the participants. Each of the items can be scored on a Likert scale from 1 to 7; 1 being totally disagree and 7 being totally agree. In addition, the questionnaire is divided into 3 subtypes with their respective dimensions: Frantic subtype (Involvement, Ambition and Overload), Unchallenged subtype (Indifference, Boredom and Lack of Development), Worn-out subtype (Abandonment, Lack of Control and Lack of Recognition). The Burnout Clinical Subtypes Questionnaire (BCSQ-12) also assesses burnout and is calculated with the items of the BCSQ-36. At baseline and immediately after the intervention (within 7 days after the last session)
Primary Changes in Burnout levels assessed using the Burnout Maslach Burnout Inventory (MBI) The Burnout Maslach Burnout Inventory (MBI) is a tool for the assessment of burnout, as an antithesis of the UWES questionnaire focused on engagement. This questionnaire consists of 22 items that give rise to 3 dimensions: Emotional exhaustion (decrease and loss of energy or emotional resources); Depersonalization or Cynicism (negative attitudes and feelings towards the people for whom the work is intended) and Lack of personal accomplishment or professional efficacy (tendency of professionals to evaluate themselves negatively). At baseline and immediately after the intervention (within 7 days after the last session)
Primary Changes in Burnout levels assessed using one Item for Burnout assessment One Item for Burnout assessment where under the statement of "In general, according to your definition of burnout, how would you rate your level of burnout?" participants have 5 response options from "I enjoy my work. I have no symptoms of burnout" to "I feel completely burned out and often wonder if I can keep going. I am at a point where I may need some changes or should seek some kind of help." At baseline and immediately after the intervention (within 7 days after the last session)
Secondary Changes in work engagement Assessed through the Utrecht Work Engagement Scale (UWES), which is a scale widely used for the evaluation of engagement in the workplace . It is composed of 17 items distributed in three factors: 1) vigor (6 items, e.g., "In my work I feel full of energy"), 2) dedication (6 items, e.g., "My work has meaning") and 3) absorption (5 items, e.g., "When I am working I forget everything that happens around me"). It consists of a seven-item Likert scale (from 0 = "never" to 6 = "always"). At baseline and immediately after the intervention (within 7 days after the last session)
Secondary Changes in Health-related quality of life It will be assessed using the EQ-5D-5L Questionnaire (EuroQoL 5 dimensions 5 levels): it is a questionnaire consisting of 5 dimensions with 5 levels of response, the first dimension refers to mobility, the second to personal care, the third to daily activities, the fourth to pain/discomfort, and the fifth to anxiety and depression. At baseline and immediately after the intervention (within 7 days after the last session)
Secondary Changes in Health Status It will be assessed using the Visual Analog Scale of the EQ-5D-5L Questionnaire (EuroQoL 5 dimensions 5 levels). It is represented as a thermometer ranging from 0 to 100, where 0 is the worst state of health that can be imagined and 100 is the best state of health imaginable. At baseline and immediately after the intervention (within 7 days after the last session)
Secondary Changes in pain Assessed through a visual analog pain scale, which is represented as a thermometer ranging from 0 to 100, where 0 is the absence of pain and 100 the highest pain level imaginable At baseline and immediately after the intervention (within 7 days after the last session)
Secondary Changes in blood pressure Systolic and diastolic blood pressure using the Omron MIT Elite Plus Oscillometer At baseline and immediately after the intervention (within 7 days after the last session)
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