Impact of Auditory Environments on Pain in Fibromyalgia: a 4×4 Crossover Trial
CompletedNot applicableNCT07037134
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Impact of Auditory Environments on the Functioning of Pain Mechanisms in Fibromyalgia Syndrome: a Randomized, Triple-blind, Placebo-controlled 4×4 Crossover Trial
- Conditions
- Interventions
- Other: Natural soundscape exposure
- Other: Urban soundscape exposure
- Other: Broadband sound exposure
- Other: Blank tape attention placebo control
- Sponsor
- Universidad de Granada
- Start date
- 2025-08-04
- Primary completion
- 2025-10-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * A diagnosis of misophonia or auditory processing disorders, as documented in the participant's medical record. * Concurrent neuropathic or acute pain. * Severe cognitive impairment, defined as a Mini-Mental State Examination score ≤ 17. * Severe psychiatric disorders in the symptomatic phase. * History of substance abuse in the past 12 months or current substance use disorder as reported by the participant. * Changes in ongoing therapy during or within one month prior to study enrollment per participant self-reports. * Central nervous system disorders. * Any other serious or unstable medical condition that could interfere with study participation. * Known allergies or hypersensitivity to study materials. * Pregnancy, lactation, or being within three months postpartum at the time of study enrollment.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07037134