Effect of Soundscapes on Emotional Distress in Fibromyalgia: a 4×4 Crossover Trial
A legfontosabb adatok
- Ki végzi
- Universidad de Granada
- Hol
- Spanyolország1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 72 fő vett részt
- Kezdés
- 2025. nov. 24.
- Befejezés
- 2026. febr. 6.
- A vizsgálat típusa
- Beavatkozással járó, 4 csoport
- A vizsgált kezelések
- Natural soundscape exposure
- Urban soundscape exposure
- Broadband sound active control
- Blank tape
- A regiszteradat frissítve
- 2026. február 9.
Ki vehet részt
- Életkor
- 18 év – 64 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 12 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Changes in ongoing therapy during or within one month prior to study enrollment per participant self-reports
- 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
- 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
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 4 csoportja
- Sequence NBPUEgyéb csoport
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.
Kezelés: Natural soundscape exposure, Urban soundscape exposure, Broadband sound active control és Blank tape
- Sequence UPBNEgyéb csoport
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.
Kezelés: Natural soundscape exposure, Urban soundscape exposure, Broadband sound active control és Blank tape
- Sequence BUNPEgyéb csoport
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.
Kezelés: Natural soundscape exposure, Urban soundscape exposure, Broadband sound active control és Blank tape
- Sequence PNUBEgyéb csoport
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.
Kezelés: Natural soundscape exposure, Urban soundscape exposure, Broadband sound active control és Blank tape
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Effects of Soundscapes on the Mood States, Stress, and Anxiety in Individuals With Fibromyalgia Syndrome: A Randomized, Triple-Blind, Placebo-Controlled 4×4 Crossover Trial
- A regiszteradat frissítve
- 2026. február 9.