CompletedNot Applicable

Effect of Soundscapes on Emotional Distress in Fibromyalgia: a 4×4 Crossover Trial

Spain72 participantsStarted 2025-11-24

Plain-language summary

This study tests whether different types of sounds can help reduce emotional distress in people with fibromyalgia. Fibromyalgia is a condition that causes widespread muscle and joint pain and makes people extra sensitive to sounds and other sensations. Many people with fibromyalgia also struggle with emotional distress symptoms. About half of people with fibromyalgia (54 out of 100) have depression symptoms, while 55 out of 100 also have anxiety symptoms. Researchers want to know if listening to environmental sounds can help people with fibromyalgia feel less distressed. The study will include four different types of sounds: * Natural sounds (like birds singing, water flowing, and wind in trees) * City sounds (like traffic, people talking, machines) * Broadband sounds (steady sounds like white noise) * Silence (no sound at all) People with fibromyalgia who are between 18 and 64 years old may be able to join. The study takes 4 weeks total. Each person will visit the research center 4 times over these weeks. Each visit takes about 1 hour. Visits are scheduled 1 week apart. During each visit, participants will: 1. Answer questions about how they feel before listening to sounds. 2. Lie comfortably and listen to one type of sound for 20 minutes through headphones. 3. Answer the same questions again after listening. Each person will try all 4 types of sounds in a random order. This helps researchers compare how each sound affects the same person. Before and after each sound session, participants will fill out questionnaires about: * Their mood states at the moment of evaluation * How stressed they feel at the moment of evaluation * How anxious they feel at the moment of evaluation These questionnaires have been tested in many studies and work well for people with chronic pain conditions. Participants' mood, stress, and anxiety levels might change after listening to certain sounds. If the study shows that sounds help, this could lead to new treatment options and preventive measures that are easy to use and would be safe and cost much less than medications.

Who can participate

Age range18 Years – 64 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A diagnosis of fibromyalgia syndrome, documented in the medical record provided by the participant prior to enrollment. * 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. * 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. * 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.

What they're measuring

Mood states

Timeframe: Change from immediately before to immediately after each 20-minute intervention session during each of the four crossover periods

Trial details

NCT IDNCT07231289

SponsorUniversidad de Granada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-06