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Search / Trial NCT07037134

Impact of Auditory Environments on Pain in Fibromyalgia: a 4×4 Crossover Trial

Launched by UNIVERSIDAD DE GRANADA · Jun 21, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Acoustic Environment Audioanalgesia Blank Tape Broadband Noise Chronic Primary Pain Clinical Trial Crossover Fibromyalgia Natural Sound Pain Modulation Pink Noise Soundscape Urban Sound White Noise

ClinConnect Summary

This study is looking at whether different types of sounds can help reduce pain for people with fibromyalgia, a condition that causes widespread pain and sensitivity. Researchers will compare four sound environments: natural sounds like birdsong and rain, urban sounds such as traffic and background chatter, steady noises like white or pink noise, and silence. The goal is to see if any of these sounds make pain feel better and if some are more helpful than others.

If you have fibromyalgia, moderate or higher pain, and normal hearing, you might be able to join. Participants will take part in four sessions, one per week, where they will listen to each type of sound for 20 minutes while resting comfortably. Before and after each session, researchers will check pain levels to see if the sounds have any effect. This study could help develop new, simple ways to manage fibromyalgia pain using sound.

Gender

ALL

Eligibility criteria

  • 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.

About Universidad De Granada

The Universidad de Granada is a prestigious academic institution in Spain, renowned for its commitment to research and innovation in the medical and health sciences. With a strong emphasis on interdisciplinary collaboration, the university engages in a wide range of clinical trials designed to advance medical knowledge and improve patient care. Its dedicated team of researchers and clinicians work closely to ensure the ethical conduct and scientific rigor of all trials, contributing to the advancement of evidence-based medicine. The Universidad de Granada is dedicated to fostering an environment that promotes excellence in research, ultimately aiming to translate findings into clinical practice for the benefit of society.

Locations

Granada, , Spain

Patients applied

0 patients applied

Trial Officials

José Manuel Pérez Mármol, PhD

Principal Investigator

Department of Physiotherapy, Faculty of Health Sciences, University of Granada

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported