The Impact of Enhanced Music & Natural Visuals on Emotional Health
23. června 2026 aktualizováno: soundBrilliance LLC
Impacts of Music, Audio Enhancements, Audio Guidance, and Visuals on Physical and Emotional Well-being. (Emotional Health - Longitudinal 1 Randomized, Controlled Multi-center Study)
The investigators are conducting research on factors related to the self-regulation of mood and arousal states across a range of everyday activities as well as different levels of stress. Behavioral interventions-such as meditation, listening to music, or visualizing art or nature-offer important alternatives and/or adjunctive strategies to pharmaceutical tools or other mechanisms supporting physical and emotional well-being. This research will expand on the knowledge base regarding the impact of biophysical stimulation and/or frame of mind on an individual's self-directed management of physical and emotional health. Motivation, confidence, and composure are critical aspects of self-efficacy, framing a person's mindset to make healthy choices across daily activities.
The research in this protocol is carried out across multiple sites and studies by means of digital tools and a consistent participant experience workflow. Together, these resources are intended to support individuals across multiple self-directed experiences utilized in the maintenance of their basic health. Before, during, and after session experiences, the participant provides objective (physiological) responses and/or subjective (self-report) responses and reflections; some studies also include interviews or focus groups. The combined set of responses can be summarized, connected to other measures, and input to machine learning models to improve personalization of stimuli. By studying the effects of soundBrilliance experiences across a variety of contexts and participant samples, the investigators can better refine each element of the stimulus to improve satisfaction, tolerance, and targeted outcomes.
Přehled studie
Postavení
Postavení
Nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Intervenční
Zápis (Odhadovaný)
Zápis
200
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Robert Mele (VP of Clinical Research & Testing Operations), B.Eng
- Telefonní číslo: 1 7752444866
- E-mail: rob.mele@soundBrilliance.com
Studijní záloha kontaktů
- Jméno: Justin C Hayes (Manager, Research & Testing Operations), MA
- Telefonní číslo: 515-777-4591
- E-mail: justin.hayes@soundBrilliance.com
Studijní místa
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Colorado
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Fort Collins, Colorado, Spojené státy, 80523
- Nábor
- Colorado State University
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Kontakt:
- Blythe LaGasse, PhD
- Telefonní číslo: 970-491-4042
- E-mail: blagasse@colostate.edu
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Nebraska
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Omaha, Nebraska, Spojené státy, 68178
- Nábor
- Creighton University
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Kontakt:
- Ryan Batenhorst, EdD
- Telefonní číslo: 402-730-6632
- E-mail: RyanBatenhorst@creighton.edu
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Kontakt:
- Thomas L Lenz, PharmD
- Telefonní číslo: 402-280-3144
- E-mail: ThomasLenz@creighton.edu
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Nevada
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Reno, Nevada, Spojené státy, 89511
- Nábor
- Reno Running Company
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Kontakt:
- Anna Costello
- Telefonní číslo: 775-303-5845
- E-mail: Anna.Costello@WashoeSchools.net
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria:
- You are 13 years of age or older
- You can read, write, and speak English at a 5th-grade level or higher
- You are legally capable of providing informed consent (adult participants) or capable of providing assent (child participants)
- To the best of your knowledge, you are willing and able to commit to the session(s) and activities of this study
- You are willing and able to use the sound-delivery and data-collection apparatus of this study
- You are willing to use your own personal equipment. Depending on the study, you may need to have your own ear buds/headphones and/or a "smart" device with internet and/or Bluetooth access (e.g., smartphone, iPad).
- You have normal hearing in both ears.
- You never experience ringing noises or buzzing sensations in your ears (tinnitus)
- You do not use a heart/cardiac pacemaker and do not have any history of cardiac rhythm disturbances, such as cardiac conduction delays or blocks
- You have no known history of fainting, fainting, spells or seizures, spinning sensations, or trouble with balance (medical terms include epilepsy, seizures, syncope, vertigo, nystagmus)
- You do not use of any of the following medications: Beta blockers, steroids, ephedrine, acute anti-anxiety medication (e.g., benzodiazepines such as diazepam/Valium, lorazepam/Ativan or clonazepam/Klonopin), or acute or chronic pain medications (including narcotics and codeine)
- For any study session, you will not be under the influence of any substances that could prevent safe participation and will not have consumed e.g., alcohol, THC, Psilocybin, or other mood-altering drugs in the 12 hours preceding the session.
Exclusion Criteria:
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Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Aktivní komparátor: Group A - Intervention
Group A will be given access to the intervention (use of the soundBrillinace app) for 12 weeks
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Use of the soundBrilliance app (enhanced music, natural visuals, spoken guidance) over 12 weeks, targeting use of 4 days or more per week.
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Žádný zásah: Group B
Group B will receive no intervention (behavior as usual) for 12 weeks.
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in State Trait Anxiety Inventory - State (STAI-S) between treatment vs control groups.
Časové okno: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
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The 20 item STAI-S, a self-report survey reflecting current symptoms of anxiety, will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol.
The difference in group mean change of STAI-S from baseline across 2-week milestones will be estimated.
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Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
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Change in Patient Health Questionnaire (8 question; PHQ-8) between treatment vs control groups.
Časové okno: Baseline and at 2-week intervals over the duration of the 12-week protocol (0, 2, 4, 6, 8, 10, 12-week post-baseline).
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The 8 item PHQ-8, a self-report survey reflecting current symptoms of depression, will be given to both groups at baseline and at 20week intervals through the duration of the 12-week protocol.
The difference in group mean change of PHQ-8 from baseline across 2-week milestones will be estimated.
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Baseline and at 2-week intervals over the duration of the 12-week protocol (0, 2, 4, 6, 8, 10, 12-week post-baseline).
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Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) between treatment vs control groups.
Časové okno: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
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The 20 item PANAS-SF will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol.
The difference in group mean change of positive and negative affect scores from baseline across 2-week milestones will be estimated.
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Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Perceived Stress (PSS - 10 item) between treatment vs control groups.
Časové okno: Baseline and at week 12 (0, 12 weeks post-baseline).
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The 10 item PSS will be given to both groups at baseline and at 12-week protocol completion.
The difference in group mean change of STAI-S from baseline across 2-week milestones will be estimated.
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Baseline and at week 12 (0, 12 weeks post-baseline).
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Change in Quality of Life (Cantril's Ladder) between treatment vs control groups.
Časové okno: Baseline and at week 12 (0, 12 weeks post-baseline).
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Cantril's Ladder, a quality of life (QoL) measure, will be given to both groups at baseline and at the conclusion of the 12-week protocol (week 12).
The difference in group mean change of QoL from baseline to post-study will be estimated.
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Baseline and at week 12 (0, 12 weeks post-baseline).
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Change in Beck Depression Inventory-II (21 item; BDI-II) between treatment vs control groups.
Časové okno: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
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The 21 item BDI-II will be given to participants in a cohort supervised by a clinical sub-investigator providing ongoing care.
The BDI-II will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol.
The difference in group mean change of composite scores from baseline across 2-week milestones will be estimated.
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Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
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Planned Sub-group Analysis of Age
Časové okno: Baseline throughout the 12 week protocol. (0, 2, ... 12 weeks).
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We will do subgroup analysis with contrasts by age in years, for groups 13-17, 18-29, 30-49, 50+
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Baseline throughout the 12 week protocol. (0, 2, ... 12 weeks).
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Planned Sub-group Analysis of Sex
Časové okno: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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We will do subgroup analysis with contrasts by sex for groups male versus female.
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Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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Planned Sub-group Analysis of baseline scores of PSS
Časové okno: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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We will do subgroup analysis with contrasts by PSS (Perceived Stress Scale survey) baseline score for groups categorized into Low, Moderate, and High perceived stress.
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Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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Planned Sub-group Analysis of baseline scores of STAI-Trait Anxiety
Časové okno: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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We will do subgroup analysis with contrasts by STAI-Trait Anxiety baseline score for groups categorized into Low or No, Moderate, and High perceived anxiety and combinations thereof such as Low or No versus Moderate and High.
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Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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Planned Sub-group Analysis of baseline scores of Cantril's Ladder
Časové okno: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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We will do subgroup analysis with contrasts by Cantril's Ladder for the linear relationship between predictor and outcome.
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Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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Planned Sub-group Analysis of baseline scores of MAIA
Časové okno: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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We will do subgroup analysis with contrasts by MAIA (Multidimensional Assessment of Interoceptive Awareness survey) baseline score for groups categorized into Low (below 25th percentile), Average (25th to 75th percentile) and High (above 75th percentile) and combinations thereof such as Low versus Average and High.
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Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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Planned Sub-group Analysis of baseline scores of MAAS
Časové okno: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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We will do subgroup analysis with contrasts by MAAS (Mindful Attention Awareness Scale survey) for the linear relationship between predictor and outcome.
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Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
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Summarization of subjective Tolerance of stimuli
Časové okno: Tolerance data collected at completion of sessions, over the duration of 12-week protocol.
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Subjects have the option to report subjective tolerance of stimuli on a per-session basis.
These data will be reported using descriptive statistics such as counts (n's) and percentages of reports as well as summarized free-text responses.
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Tolerance data collected at completion of sessions, over the duration of 12-week protocol.
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Summarization of subjective Satisfaction with stimuli
Časové okno: Satisfaction data collected at completion of sessions, over the duration of 12-week protocol.
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Subjects have the option to report their satisfaction with stimuli on a per-session basis.
These data will be reported using descriptive statistics such as mean and standard deviation of 6-point Likert scale responses as well as summarized free-text responses.
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Satisfaction data collected at completion of sessions, over the duration of 12-week protocol.
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Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) from baseline pre and post session.
Časové okno: Pre and post stimuli for each treatment session over the duration of 12-week protocol
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The 20 item PANAS-SF, a self-report survey, will be an optional measure for the treatment group for each session pre and post stimuli through the duration of the 12-week protocol.
The change in scores from baseline to post session will be assessed over time.
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Pre and post stimuli for each treatment session over the duration of 12-week protocol
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Change in State Trait Anxiety Inventory - State (6 item; STAI-S) from baseline pre and post session.
Časové okno: Pre and post stimuli for each treatment session over the duration of 12-week protocol.
|
The 6-item STAI-S, a self-report survey reflecting current symptoms of anxiety, will be an optional measure for the treatment group for each session pre and post stimuli through the duration of the 12-week protocol.
The change in scores from baseline to post session will be assessed over time.
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Pre and post stimuli for each treatment session over the duration of 12-week protocol.
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Change in Modified Russel Circumplex (2 item; MRC Arousal & Valence axis)
Časové okno: Pre and post stimuli for each treatment session over the duration of 12-week protocol
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The 2-item MRC, a self-report survey reflecting Arousal level (9-point Likert from Low Energy to High Energy) and Valence (9-point Likert from Unpleasant to Pleasant), will be an optional measure for the treatment group for each session pre and post stimuli through the duration of the 12-week protocol.
The change in ratings from baseline to post session will be assessed over time.
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Pre and post stimuli for each treatment session over the duration of 12-week protocol
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Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Heart Rate Variability (Root Mean Square Successive Differences; RMSSD) between pre to post session in treatment group.
Časové okno: Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
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A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session.
RMSSD will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.
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Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
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Change in Sympathetic Nervous System (SNS) activation between pre to post session in treatment group.
Časové okno: Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
|
A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session.
SNS will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.
|
Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
|
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Change in Parasympathetic Nervous System (PNS) activation between pre to post session in treatment group.
Časové okno: Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol
|
A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session.
PNS will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.
|
Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol
|
|
Change in Stress Index between pre to post session in treatment group.
Časové okno: Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
|
A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session.
Stress Index (SI) will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.
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Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
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Beneficial change in both physiological and psychometric outcomes
Časové okno: Pre-post change measurements throughout study sessions for all sessions completed during the 12-week protocol.
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For the outcomes that have both categorical and continuous interpretations.
Changes from categorical baseline conditions will be tested using McNemar's Test (Shift Table).
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Pre-post change measurements throughout study sessions for all sessions completed during the 12-week protocol.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Jason S Doescher, MD, soundBrilliance LLC
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
- Taylor JM. Psychometric analysis of the Ten-Item Perceived Stress Scale. Psychol Assess. 2015 Mar;27(1):90-101. doi: 10.1037/a0038100. Epub 2014 Oct 27.
- Thompson, E. R. (2007). Development and validation of an internationally reliable short-form of the positive and negative affect schedule (PANAS). Journal of Cross-Cultural Psychology, 38(2), 227-242.
- Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
- Mohammed SEE, Warner G. The Cantril Ladder as a Measure of Well-Being and Life Satisfaction Among Refugee Youth Experiencing Symptoms of Post-Traumatic Stress. J Immigr Minor Health. 2024 Jun;26(3):539-545. doi: 10.1007/s10903-023-01563-5. Epub 2023 Oct 26.
- Spielberger, C. D. (1983). Manual for the State-Trait Anxiety Inventory: STAI (Form Y). Palo Alto, CA: Mind Garden.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
25. května 2026
Primární dokončení (Odhadovaný)
Primární dokončení
1. prosince 2026
Dokončení studie (Odhadovaný)
Dokončení studie
1. června 2027
Termíny zápisu do studia
První předloženo
První předloženo
1. května 2026
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
23. června 2026
První zveřejněno (Aktuální)
První zveřejněno
30. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
30. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. června 2026
Naposledy ověřeno
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- SBEMHL001
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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produkt vyrobený a vyvážený z USA
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .