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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Mood states
研究概览
简要总结
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.
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.
详细描述
This study investigates whether distinct soundscapes can alleviate emotional distress symptoms in individuals with fibromyalgia syndrome. The study's theoretical foundation is grounded in converging evidence from environmental neuroscience and psychology research demonstrating that auditory stimuli can significantly influence emotional processing through neural pathways connecting the auditory cortex with brain areas involved in emotional regulation. By investigating how different soundscapes influence emotional distress, this research may contribute to the field of environmental psychology, as well as inform environmental health policies and acoustic design strategies for healthcare settings.
Soundscapes represent acoustic environments that are perceived, experienced, and interpreted within specific contexts. For research purposes, soundscapes are categorized based on their sources: natural soundscapes comprise biophonies (sounds produced by non-human living organisms) and geophonies (sounds generated by non-biological natural processes), while urban soundscapes feature anthropophonies (human-generated sounds) and technophonies (sounds produced by mechanical and technological sources).
Emerging neuroscientific research has identified direct neural pathways between the auditory cortex and emotion-processing brain areas, including the limbic and paralimbic regions. These auditory-emotion connections may provide a neurobiological foundation for investigating how environmental soundscapes might modulate emotional states in populations with altered sensory processing. Moreover, numerous studies conducted in healthy populations suggest that soundscapes can influence mood states and stress levels. Natural soundscapes have been shown to elicit distinct neural signatures compared to urban soundscapes, with differential effects on emotional distress symptoms.
Fibromyalgia syndrome affects approximately 2 to 3% of the global population and is commonly associated with emotional distress, with clinical symptoms of depression and anxiety occurring in 54% and 55% of affected individuals, respectively. This high prevalence of emotional comorbidity significantly impacts various aspects of life in this population. The hypothalamic-pituitary-adrenal axis dysfunction observed in fibromyalgia may contribute to altered stress responsivity and emotional regulation difficulties. Furthermore, the chronic pain experience itself can precipitate and maintain emotional distress through various psychological mechanisms. The substantial emotional burden associated with fibromyalgia necessitates efficacious strategies that can address emotional distress symptoms characteristic of this condition.
The use of environmental acoustic stimuli to influence emotional distress symptoms may offer a promising management strategy in individuals with fibromyalgia. This proposition is supported by two core characteristics of the condition. First, fibromyalgia is associated with increased sensory sensitivity, which may heighten responsiveness to acoustic features of the environment. Second, emotion regulation difficulties have been identified as a key factor mediating the relationship between fibromyalgia symptoms and emotional distress. In particular, individuals with fibromyalgia often demonstrate reduced efficacy in employing adaptive emotion regulation strategies, such as cognitive reappraisal and emotional acceptance. These limitations may contribute to the persistence and intensification of affective symptoms. Together, these factors indicate that environmental sounds capable of modulating emotional distress symptoms through non-cognitive mechanisms represent a theoretically grounded and clinically relevant intervention approach for this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ≤
- •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.
研究组 & 干预措施
Sequence NBPU
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.
干预措施: Natural soundscape exposure (Other)
Sequence NBPU
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.
干预措施: Urban soundscape exposure (Other)
Sequence NBPU
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.
干预措施: Broadband sound active control (Other)
Sequence NBPU
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.
干预措施: Blank tape (Other)
Sequence UPBN
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.
干预措施: Broadband sound active control (Other)
Sequence UPBN
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.
干预措施: Blank tape (Other)
Sequence UPBN
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.
干预措施: Natural soundscape exposure (Other)
Sequence UPBN
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.
干预措施: Urban soundscape exposure (Other)
Sequence BUNP
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.
干预措施: Natural soundscape exposure (Other)
Sequence BUNP
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.
干预措施: Urban soundscape exposure (Other)
Sequence BUNP
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.
干预措施: Broadband sound active control (Other)
Sequence BUNP
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.
干预措施: Blank tape (Other)
Sequence PNUB
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.
干预措施: Natural soundscape exposure (Other)
Sequence PNUB
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.
干预措施: Urban soundscape exposure (Other)
Sequence PNUB
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.
干预措施: Broadband sound active control (Other)
Sequence PNUB
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.
干预措施: Blank tape (Other)
结局指标
主要结局
Mood states
时间窗: Change from immediately before to immediately after each 20-minute intervention session during each of the four crossover periods
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.
次要结局
- 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)
研究者
José Manuel Pérez Mármol
Associate Professor
Universidad de Granada