Impact of Auditory Environments on the Functioning of Pain Mechanisms in Fibromyalgia Syndrome: a Randomized, Triple-blind, Placebo-controlled 4×4 Crossover Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study examines whether different types of sounds can help reduce pain in people with fibromyalgia, a chronic condition that causes widespread pain and increased sensitivity to sensory experiences. Fibromyalgia affects approximately 2-3% of the global population and has limited treatment options. Recent research suggests that environmental sounds might have the capacity to influence pain perception, but their effects in chronic pain conditions remain largely unexplored. Such research could lead to new, non-invasive, sound-based approaches for managing fibromyalgia pain and inform the design of healthier acoustic environments for people with chronic pain conditions. The study will compare four different sound environments: natural soundscapes (like birdsong and rainfall), urban soundscapes (like traffic and background conversation), broadband sounds (white or pink noise), and silence (as a neutral/control condition with intended placebo effect). Researchers want to know if these different sound environments can change how people with fibromyalgia experience pain and if some environmental sounds might be more helpful than others. Each participant will experience all four sound conditions in a random order, with one session per week over four weeks. With this study design, each participant acts as their own control, which reduces differences between individuals and increases the reliability of the results. During each 20-minute session, participants will listen to the assigned sounds through a high-fidelity sound reproduction setup using headphones while lying comfortably on a padded therapy table in a controlled laboratory setting. Before and after each sound exposure, researchers measure pain intensity and sensitivity using standardized assessments to determine whether and how different sound environments, if any, might offer pain relief.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A diagnosis of fibromyalgia syndrome, documented in the medical record provided by the participant prior to enrollment.

• Moderate or greater pain intensity during the preceding week, defined as a score higher than 3 on an 11-point Numeric Rating Scale.

• Normal hearing confirmed by a hearing test, defined as a mean threshold of ≤ 20 dB HL at 0.125, 0.25, 0.5, 1, 2, 4, 6, and 8 kHz.

• Ability to communicate in Spanish.

• Provision of signed written informed consent to participate in the research.

Locations
Other Locations
Spain
Faculty of Health Sciences, University of Granada
RECRUITING
Granada
Contact Information
Primary
José Manuel Pérez Mármol, PhD
josemapm@ugr.es
(+34) 958 24 62 18
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2025-10
Participants
Target number of participants: 88
Treatments
Other: Sequence NBPU
Participants assigned to this sequence receive natural soundscape exposure in Week 1, broadband sound exposure in Week 2, placebo control (blank tape) in Week 3, and urban soundscape exposure in Week 4. Each session lasts 20 minutes, with one-week washout intervals between sessions.
Other: Sequence UPBN
Participants assigned to this sequence receive urban soundscape exposure in Week 1, placebo control (blank tape) in Week 2, broadband sound exposure in Week 3, and natural soundscape exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
Other: Sequence BUNP
Participants assigned to this sequence receive broadband sound exposure in Week 1, urban soundscape exposure in Week 2, natural soundscape exposure in Week 3, and placebo control (blank tape) in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
Other: Sequence PNUB
Participants assigned to this sequence receive placebo control (blank tape) in Week 1, natural soundscape exposure in Week 2, urban soundscape exposure in Week 3, and broadband sound exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
Related Therapeutic Areas
Sponsors
Leads: Universidad de Granada

This content was sourced from clinicaltrials.gov