NCT05100108

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

October 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

October 16, 2021

Last Update Submit

October 27, 2021

Conditions

Keywords

dog-assistedBurnoutQuality of lifeWork EngagementHuman-animal interactionAnimal-assisted

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (5)

  • Changes in work engagement

    At baseline and immediately after the intervention (within 7 days after the last session)

  • Changes in Health-related quality of life

    At baseline and immediately after the intervention (within 7 days after the last session)

  • Changes in Health Status

    At baseline and immediately after the intervention (within 7 days after the last session)

  • Changes in pain

    At baseline and immediately after the intervention (within 7 days after the last session)

  • Changes in blood pressure

    At baseline and immediately after the intervention (within 7 days after the last session)

Study Arms (2)

Control group

NO INTERVENTION

They will be on a waiting list. They will be assessed before and after the 8 week program but will not take part in it.

Experimental group

EXPERIMENTAL

Participants in this group will take part in the 8 sessions of dog-assisted therapy. They will be assessed before and after the 8 week program.

Behavioral: Dog-assisted therapy

Interventions

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.

Also known as: animal-assisted therapy, animal-assisted intervention
Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be aged \>18 years
  • be workers in a School for Special Education
  • work in direct contact with children (teachers, physiotherapists, etc.)

You may not qualify if:

  • People with dog-allergy
  • People with dog phobia
  • People with a history of impulsive animal aggression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Juan Carlos University

Móstoles, Madrid, 28933, Spain

RECRUITING

MeSH Terms

Conditions

Occupational StressBurnout, PsychologicalHuman-Animal Interaction

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Daniel Collado-Mateo, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Collado-Mateo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will be aware of the group they belong. Assessors and investigators will not be aware of the group participants belong.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with two groups: a) the experimental group and b) a control group (waiting list)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 16, 2021

First Posted

October 29, 2021

Study Start

October 26, 2021

Primary Completion

December 23, 2021

Study Completion

December 23, 2021

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations