Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07356206

Between Paws and Affections: Impact of Dog Assisted Therapy on Pain, Emotional Symptoms, and Functioning in Fibromyalgia

Led by University of Minho · Updated on 2026-05-05

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Minho

Lead Sponsor

U

Unidade Local de Saúde do Alto Ave, EPE

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of a structured dog-assisted therapy program called "Entre Patas e Afetos" (Between Paws and Affections) on Portuguese patients with fibromyalgia. The study aims to evaluate how this therapy reduces pain, anxiety, and depressive symptoms while improving functional status and quality of life. Outcomes are assessed immediately after the intervention, and then again at 6 and 12 months to understand medium-term maintenance of benefits. The trial includes an intervention group receiving 10 group sessions at the Psychiatry Day Hospital of ULS Alto Ave. These sessions consist of 4 weekly structured dog-assisted therapy sessions combining education on fibromyalgia, functional training, self-care, lifestyle advice, and guided relaxation mediated by trained therapy dogs and a professional handler. This is followed by 6 monthly guided relaxation booster sessions with the dogs. A control group receives the same 10-session program without dogs, matching the structure, duration, and content of the intervention. Participants provide informed consent and complete baseline questionnaires before starting. Assessments occur after the fourth session, at 6 months, before the tenth session, and 12 months after the intervention ends. The study includes evaluations of pain intensity and interference, fibromyalgia impact and function, anxiety, depressive symptoms, and pain catastrophizing. The therapy is delivered by a multidisciplinary team with veterinary and safety oversight. The total participation spans about 13 months, including follow-up periods to monitor progress and maintenance of results.

CONDITIONS

Brief Title

Between Paws and Affections - Impact of Dog-Assisted Therapy in Fibromyalgia Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed diagnosis of fibromyalgia
  • Being followed at ULS Alto Ave by the Multidisciplinary Pain Unit, Internal Medicine (Auto immune diseases), Physical and Rehabilitation Medicine or Neurology
  • Ability to read and write Portuguese and to understand the study procedures
  • Willingness and ability to participate voluntarily in the 10 session program and all scheduled assessments (T1-T4)
  • Provision of written informed consent
Not Eligible

You will not qualify if you...

  • Allergy to dogs or marked fear of dogs
  • History of aggression towards animals
  • History of oncological disease
  • Concomitant systemic or rheumatologic disease that may confound pain and functional assessment
  • Decompensated psychiatric disorder or severe cognitive impairment that may compromise comprehension of the protocol or adherence to the intervention
  • Refusal to participate or withdrawal of consent at any point

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 7 months

Participants attend a total of 10 group sessions over several months. This includes 4 weekly structured sessions combining psychoeducation, functional training, lifestyle counseling, and guided relaxation, followed by 6 monthly guided relaxation booster sessions.

4 weekly visits followed by 6 monthly visits (in-person)

Follow-up

Duration - Up to 12 months after treatment start

Participants complete follow-up assessments at multiple time points to monitor short-term response, maintenance of gains, and long-term outcomes.

Assessments immediately after session 4, at 6 months, before session 10, and at 12 months after intervention end

Trial Site Locations

Total: 1 location

1

Unidade Local de Saúde (ULS) Alto Ave

Guimarães, Portugal, 4835-044

Actively Recruiting

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Research Team

A

Armando Almeida, Associate Professor

F

Filipa Martins-Alves, Psychiatric Hospital Assistant

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Oxytocin and Cortisol Levels in Dog Owners and Their Dogs Are Associated with Behavioral Patterns: An Exploratory Study.

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[Cultural adaptation and validation of the "Fibromyalgia Impact Questionnaire"--Portuguese version].

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https://pubmed.ncbi.nlm.nih.gov/17058362

The Role of Animal-Assisted Therapy in Enhancing Patients' Well-Being: Systematic Study of the Qualitative and Quantitative Evidence.

Ramendra Pati Pandey, Himanshu, Gunjan...

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