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

The purpose of this study is to evaluate the effectiveness and medium-term maintenance of a structured dog-assisted therapy (DAT) protocol, "Entre Patas e Afetos" (Between Paws and Affections), in reducing pain, anxiety and depressive symptoms and in improving functional status and quality of life in Portuguese patients with fibromyalgia (FM) followed at ULS Alto Ave, with systematic outcome assessment in the immediate post intervention phase (T2), 6-month follow-up (T3) and 12-month follow-up (T4).

ClinicalTrials.gov IDNCT07356206

PhaseNA

Enrollment60

SponsorUniversity of Minho

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Fibromyalgia (FM)

About this study

Interventions

Behavioral: Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections") — Dog Assisted Therapy (DAT - "Between Paws and Affections") - Intervention group that will receive a total of 10 group sessions at the Psychiatry Day Hospital of ULS Alto Ave, organized into 4 weekly structured sessions (combining psychoeducation on fibromyalgia and chronic pain, functional training and self care, lifestyle counseling and guided relaxation, all mediated by trained therapy dogs and a professional dog handler), followed by 6 monthly guided relaxation "booster" sessions with the dogs.
Behavioral: Behavioral: Psychoeducation and Relaxation without Dogs (Control) — Control group that will receive the same 10 session program, with structure, duration and content identical to the DAT arm (4 weekly structured psychoeducation and functional/self care sessions plus 6 monthly guided relaxation "booster" sessions), but delivered entirely without dogs.

Primary outcomes

Pain intensity (maximum and average) and pain interference (13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month)
Fibromyalgia impact and functional status (13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month)

Eligibility information

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations

Unidade Local de Saúde (ULS) Alto Ave, Guimarães, 4835-044 Portugal

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.