- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07673653
Comparative Effects of Meditation, Nature Exposure, and Digital Activities on Physiological and Perceived Stress
Comparative Effects of Meditation, Nature Exposure, Digital Scrolling, and Reading on Physiological and Perceived Stress: A Non-Randomized Controlled Study
The present study aims to compare the effects of meditation, nature exposure, digital scrolling, and reading on physiological and perceived stress. Participants will undergo a baseline assessment including the Five Facet Mindfulness Questionnaire (FFMQ), a visual analogue scale (VAS) for anxiety, and salivary cortisol collection at 8:30 a.m, prior to cortisol peak. Participants will then engage in one of four activities: guided meditation, a walk in a forest environment, digital scrolling on a smartphone, or reading a neutral text. Following the activity, salivary cortisol will be collected again and anxiety will be reassessed using the VAS. The study will evaluate changes in cortisol levels, perceived stress and perceived anxiety across the four conditions and explore the potential moderating role of baseline mindfulness traits.
The central research question of this study is whether different experiential conditions elicit distinct psychophysiological responses, as reflected by changes in perceived stressm salivary cortisol and perceived anxiety and therefore this investigation could improve the understanding of how different experiential contexts influence short-term stress regulation.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Stress is a global phenomenon. Chronic exposure to stress is associated with adverse physical and mental health outcomes, including cardiovascular disease, anxiety, depression, sleep disturbances, and impaired cognitive functioning. Consequently, identifying accessible and effective strategies for stress reduction has become a major public health priority. To explore new ways of managing it is of crucial relevance, therefore the effects of meditation, nature exposure, digital scrolling, and neutral reading on physiological and perceived stress will be investigated.
Participants will be allocated to one of 5 intervention groups: (1) guided meditation, (2) guided meditaiton (3) forest walking, (4) smartphone scrolling, or (5) reading a neutral text.
All study procedures will take place in the morning to account for the circadian rhythm of cortisol secretion. At baseline, participants will complete demographic and study-related assessments, including the Five Facet Mindfulness Questionnaire (FFMQ) and a VAS measuring current stress and anxiety levels. A baseline saliva sample for cortisol determination will be collected at 8:45 a.m., shortly before the expected morning cortisol peak.
Participants will then engage in their assigned activity. The 2 meditation groups will complete a 20-minute guided meditation session using two different meditation techniques. The forest exposure group will undertake a 20-minute walk in a forest environment. The digital activity group will spend 20 minutes scrolling on a smartphone, while the control group will spend 20 minutes reading a neutral text. The duration of the intervention will be standardized across all groups.
Immediately following completion of the assigned activity, participants will undergo a second assessment at approximately 9:00 a.m. A post-intervention saliva sample will be collected for cortisol analysis, and participants will again complete the VAS for anxiety and stress. Salivary Cortisol and DHEA levels will be evaluated at 4 time points the above already mentioned two, and in the evening and before sleeep.
The primary objective of the study is to compare changes in perceived stress. Secondary objectives include evaluating changes in cortisool levels, DHEA, perceived anxiety and exploring the relationship between baseline mindfulness traits, as measured by the FFMQ, and physiological and psychological responses to the interventions.
The study aims to provide preliminary evidence regarding the immediate effects of contemplative practice, exposure to natural environments, and digital engagement on stress-related outcomes in healthy adult participants
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Italia
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Pavia, Italia, Włochy, 27100
- Cascina Cravino Via Bassi 21
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Understanding of the Italian language
Exclusion Criteria:
- Presence of severe mental disorders and/or significant medical conditions
- Endocrine or metabolic disorders
- Substance dependence
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Experimental
Participants in this groups will undergo a mindfulness based intervention.
The meditation tecniques will differ one from the other for focused breathing, body relaxation, emotional awareness and acceptance exercises.
The intervention consists of 1 in person session of 20 minutes.
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The intervention consists of 1 in person session of mindfulness of 20 minutes.
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Brak interwencji: No Intervention
Participants in this group will not receive any psychophysiological interventions during the study.
This group serve as a passiva control group to evaluate the effectivness of the mindfulness-based intervention by comparing pre and post intervention measures.
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Aktywny komparator: Forest bathing
The forest bathing group will act as a an active control group.
Forest bathing is known to exert psyhophysiological effects on the stress response system, allowing to evaluate different stress management techniques
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Participants engaged in guided forest immersion including mindful walking, sensory awareness, meditation, and nature-based contemplative activities.The intervention consists of 1 in person session of 20 minutes.
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Aktywny komparator: Scrolling
Scrolling group will act as an active control group to evaluate the absence of the positive psychophysiological stress response.
The intervention consists of 1 in person session of 20 minutes.
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Strolling consisted of a slow, relaxed walk in a natural environment without specific mindfulness or sensory-awareness instructions.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in perceived stress.
Ramy czasowe: Baseline and immediately after the single intervention session (same day).
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Change in perceived stress measured using a Visual Analog Scale for Stress (VAS-Stress), ranging from 0 to 100, where 0 indicates no perceived stress and 100 indicates the highest level of perceived stress imaginable.
The outcome will be calculated as the difference between post-intervention and pre-intervention scores.
Negative values indicate a reduction in perceived stress following the intervention.
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Baseline and immediately after the single intervention session (same day).
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in anxiety levels
Ramy czasowe: Baseline and immediately after the single intervention session (same day).
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Change in anxiety levels measured using a Visual Analog Scale for Anxiety (VAS-Anxiety), ranging from 0 to 100, where 0 indicates no anxiety and 100 indicates the highest level of anxiety imaginable.
The outcome will be calculated as the difference between post-intervention and pre-intervention scores.
Negative values indicate a reduction in anxiety following the intervention.
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Baseline and immediately after the single intervention session (same day).
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Change in salivary cortisol concentrations
Ramy czasowe: Baseline and immediately after the single intervention session (same day).
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Change in salivary cortisol concentration (nmol/L) measured from saliva samples collected immediately before and immediately after the intervention session.
The outcome will be calculated as the difference between post-intervention and pre-intervention cortisol concentrations
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Baseline and immediately after the single intervention session (same day).
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Change in salivary DHEA concentrations
Ramy czasowe: Baseline and immediately after the single intervention session (same day).
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Change in salivary dehydroepiandrosterone (DHEA) concentration (pg/mL) measured from saliva samples collected immediately before and immediately after the intervention session.
The outcome will be calculated as the difference between post-intervention and pre-intervention DHEA concentrations
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Baseline and immediately after the single intervention session (same day).
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Correlation between trait mindfulness and physiological stress responses
Ramy czasowe: Baseline and immediately after the single intervention session (same day).
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Correlation between trait mindfulness (measured by Five Facet Mindfulness Questionnaire total score) and change in salivary cortisol concentration
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Baseline and immediately after the single intervention session (same day).
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- Correlations among psychological and biological outcome measures, including VAS-Stress, VAS-Anxiety, cortisol, and DHEA
Ramy czasowe: Baseline and immediately after the single intervention session (same day).
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Baseline and immediately after the single intervention session (same day).
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Lum_1
Plan dla danych uczestnika indywidualnego (IPD)
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Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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