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

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.

Conditions

• Fibromyalgia Syndrome

Interventions

OTHER

Natural soundscape exposure

Participants receive a standardized 20-minute auditory exposure to curated natural soundscapes via high-fidelity open-back reference headphones powered by a DAC/amplifier and corrected for frequency response using calibration software. Participants are randomly assigned a recording with 10-second fade-in/out effects and calibrated to between 45 and 55 dB (Leq,20min). The stereo recordings (320-kbps MP3, 48 kHz/24-bit) feature biophony (e.g., bird vocalizations) and geophony (e.g., rainfall), free of urban sounds and selected for ecological validity based on predefined criteria: (i) recognizable/context-specific sounds; (ii) culturally neutral; (iii) foreground presence and depth; (iv) no prolonged silence; (v) no technical artifacts. During exposure, they lie supine in a 60° Fowler's position on a therapy table, with sensory input minimized through auditory isolation and controlled ambient conditions. The session involves active listening under continuous researcher supervision.

OTHER

Urban soundscape exposure

Participants receive a standardized 20-minute auditory exposure to curated urban soundscapes, using the same equipment and technical specifications as all other intervention conditions. Each participant is randomly assigned a recording that is calibrated between 60 and 70 dB (Leq,20min), with 10-sec fade-in/fadeouts. The recordings feature anthropophony (e.g., unintelligible background speech) and technophony (e.g., transportation-related sounds), free of natural sounds and selected for ecological validity based on the same predefined criteria as the natural soundscapes. To prevent semantic processing, participants are pre-screened and post-session reconfirmed to ensure they do not understand the languages used. During exposure, participants lie supine in a 60° Fowler's position on a therapy table, with sensory input minimized through auditory isolation and controlled ambient conditions. The session involves active listening and is conducted under continuous researcher supervision.

OTHER

Broadband sound active control

Participants receive a standardized 20-minute auditory exposure to broadband sounds (i.e., white or pink noise), using the same equipment and technical specifications as all other intervention conditions. Each participant is randomly assigned to one of the two noise types, with equal distribution across conditions. The stimuli are generated using professional audio software and calibrated to 50 dB (Leq,20min). During exposure, participants lie supine in a 60° Fowler's position on a therapy table, with sensory input minimized through auditory isolation and controlled ambient conditions. The session involves active listening and is conducted under continuous researcher supervision.

OTHER

Blank tape

Participants receive a standardized 20-minute exposure to blank audio (silence), using the same equipment and technical specifications as all other intervention conditions. At study onset, participants are informed they will hear a range of environmental sounds, including some that may be inaudible (i.e., present but beyond the range of human hearing). During the placebo condition, a blank recording is played, producing silence, while participants remain unaware of whether they are receiving an active or placebo stimulus. This attention-control condition ensures procedural consistency while delivering no auditory stimulation. During exposure, participants lie supine in a 60° Fowler's position on a therapy table, with sensory input minimized through auditory isolation and controlled ambient conditions. The session involves active listening and is conducted under continuous researcher supervision.

Sponsors & Collaborators

• Universidad de Granada

  lead OTHER

Principal Investigators

• José Manuel Pérez Mármol, PhD · Department of Physiotherapy, Faculty of Health Sciences, University of Granada

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-24

Primary Completion

2026-02-06

Completion

2026-02-06

Countries

• Spain

Study Locations