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

NCT07231289 | Completed

• 1 other identifier: FIBROSOUNDS2025
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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:
• Answer questions about how they feel before listening to sounds.
• Lie comfortably and listen to one type of sound for 20 minutes through headphones.
• Answer the same questions again after listening.
• 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

Keywords

Acoustic environment; Anxiety; Blank tape; Broadband noise; Chronic pain; Chronic primary pain; Clinical trial; Crossover; Emotional distress; Fibromyalgia; Mental health; Natural sound; Pink noise; Soundscape; Stress; Urban sound; White noise

Outcome Measures

Primary Outcomes (1)

• Mood states

  The positive and negative mood states will be assessed using the shortened version of the Profile of Mood States. This version comprises 30 self-administered items, evenly distributed across six mood dimensions: tension, depression, anger, fatigue, vigor, and friendliness. Each item is rated on a five-point Likert scale ranging from zero ("not at all") to four ("extremely"), yielding subscale scores ranging from zero to 20. Higher scores on the vigor and friendliness subscales reflect a more positive mood, whereas higher scores on the remaining subscales indicate greater negative mood. A total mood disturbance index is calculated by subtracting the sum of the positive mood subscales from the sum of the negative mood subscales. The total mood disturbance score ranges from -40 to 80, with lower scores denoting less mood disturbance-that is, a more positive overall mood.

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

Secondary Outcomes (2)

• Perceived stress

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

• State anxiety

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

Other Outcomes (1)

• Connectedness to nature

  Assessed immediately after the final 20-minute intervention session, following completion of all other outcome assessments during the fourth crossover period (Week 4)

Study Arms (4)

Sequence NBPU

OTHER

Participants assigned to this sequence receive natural soundscape exposure in Week 1, broadband sound active control 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: Natural soundscape exposure; Other: Urban soundscape exposure; Other: Broadband sound active control; Other: Blank tape

Sequence UPBN

OTHER

Participants assigned to this sequence receive urban soundscape exposure in Week 1, placebo control (blank tape) in Week 2, broadband sound active control in Week 3, and natural soundscape exposure in Week 4. Each session lasts 20 minutes, with one-week washout intervals between sessions.

Other: Natural soundscape exposure; Other: Urban soundscape exposure; Other: Broadband sound active control; Other: Blank tape

Sequence BUNP

OTHER

Participants assigned to this sequence receive broadband sound active control 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: Natural soundscape exposure; Other: Urban soundscape exposure; Other: Broadband sound active control; Other: Blank tape

Sequence PNUB

OTHER

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 active control in Week 4. Each session lasts 20 minutes, with one-week washout intervals between sessions.

Other: Natural soundscape exposure; Other: Urban soundscape exposure; Other: Broadband sound active control; Other: Blank tape

Interventions

Natural soundscape exposure OTHER

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.

Also known as: Experimental intervention N

Sequence BUNP; Sequence NBPU; Sequence PNUB; Sequence UPBN

Urban soundscape exposure OTHER

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.

Also known as: Experimental intervention U

Sequence BUNP; Sequence NBPU; Sequence PNUB; Sequence UPBN

Broadband sound active control OTHER

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.

Also known as: Active control

Sequence BUNP; Sequence NBPU; Sequence PNUB; Sequence UPBN

Blank tape OTHER

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.

Also known as: Placebo attention control

Sequence BUNP; Sequence NBPU; Sequence PNUB; Sequence UPBN

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences, University of Granada

Granada, Granada, 18016, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Anxiety Disorders; Chronic Pain; Psychological Well-Being

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• José Manuel Pérez Mármol, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employs a triple-blind design: intervention administrator, outcome assessor, and data analyst will be fully blinded, while participants will remain unaware (masked, not blinded) of the study hypotheses. The intervention administrator will be blinded to the audio content being delivered, as stimuli will be labeled with non-descriptive codes by a separate investigator. The outcome assessor will not be involved in the intervention and will be blinded to group allocation. Participants will be instructed not to disclose any intervention-related information. Any potentially unblinding data that could reveal group allocation will be masked before it reaches the outcome assessor. The data analyst will receive fully de-identified datasets, with groups labeled only as "Group A/B/C/D"; unblinding will occur only after all analyses have been completed and verified.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study employs a randomized, triple-blind, placebo-controlled crossover design based on a 4×4 Williams Latin square. Each participant receives all four interventions in a randomized, balanced sequence across four periods, with one-week washout intervals separating each session to mitigate residual effects. The design ensures equal representation of each condition across periods and sequences (uniform within sequences and periods), controlling for first-order carryover effects.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 24, 2025
• Primary Completion: February 6, 2026
• Study Completion: February 6, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

ES (1)