Health TrialsbyHealthPanel

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

ConditionFibromyalgia (FM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minho

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections")

    Behavioral

    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: Psychoeducation and Relaxation without Dogs (Control)

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections")Experimental treatment 1 intervention
Group B: Behavioral: Psychoeducation and Relaxation without Dogs (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity (maximum and average) and pain interference

Measured by the Portuguese Brief Pain Inventory - Short Form , at T2 (post session 4), T3 (6 month follow up) and T4 (12 month follow up), to capture both short term change and medium term maintenance at 6 and 12 months after the first month (T2). Self reported pain intensity using a Numeric Rating Scale with faces / adapted Wong Baker Faces Pain Scale, collected at each session to monitor pain fluctuations across the acute and maintenance phases.

Time frame
13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
2

Fibromyalgia impact and functional status

Measured by the Portuguese Fibromyalgia Impact Questionnaire (FIQ P), at T2, T3 and T4, allowing evaluation of functional changes and their persistence at 6 and 12 months after the first month (T2)

Time frame
13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month

Secondary outcomes

1

Anxiety and depressive symptoms

Measured by the Hospital Anxiety and Depression Scale - Anxiety (HADS A, Portuguese version) and Depression (HADS D, Portuguese version) subscales, at T2, T3 and T4.

Time frame
13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
2

Pain catastrophizing

(total score and subscales: helplessness, magnification, rumination), assessed by the Portuguese version of the Pain Catastrophizing Scale, at T2, T3 and T4, to explore whether reductions observed after 1 month of intervention (T2) are sustained or enhanced at 6 (T3) and 12 (T4) months.

Time frame
13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minho

Lead sponsor

Unidade Local de Saúde do Alto Ave, EPE

Collaborator

Source ClinicalTrials.gov
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