Mobile App-Based Yoga and Meditation in Rheumatoid Arthritis
18. června 2026 aktualizováno: Tugba Civi Karaaslan
Effectiveness of a Mobile Application-Based Yoga and Meditation Program in Patients With Rheumatoid Arthritis: A Single-Blind Randomized Controlled Trial.
The goal of this single-blind, randomized controlled trial is to evaluate the clinical effectiveness and short-term economic impact of a mobile application-based, personalized yoga and meditation program in adult patients with Rheumatoid Arthritis (RA).
The main questions it aims to answer are:
Does an 8-week digital yoga and meditation intervention reduce anxiety and improve other clinical/psychological outcomes (such as depression, pulmonary function, reaction time, quality of life, and stress) compared to standard medical care? Does this digital intervention reduce short-term healthcare utilization and associated direct medical costs?
Researchers will compare the Mobile App Group (receiving personalized yoga and meditation via the Meditopia app) to a Control Group (receiving usual medical care) to evaluate the effectiveness and cost-efficiency of the intervention.
Participants in the experimental group will:
Use a mobile application to practice 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week over an 8-week period.
Complete clinical, psychometric, and economic assessments at baseline, week 4, and week 8.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
102
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
- Jméno: Tuğba Çivi Karaaslan, PhD
- Telefonní číslo: 40193 +902124141500
- E-mail: tugba.civi@iuc.edu.tr
Studijní záloha kontaktů
- Jméno: Pedram Shahriyari, PT
- Telefonní číslo: +905346838530
Studijní místa
-
-
Istanbul
-
Istanbul, Istanbul, Turecko (Türkiye), 34500
- Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology
-
Kontakt:
- Tuğba Çivi Karaaslan, PhD
- Telefonní číslo: 40193 +902124141500
- E-mail: tugba.civi@iuc.edu.tr
-
-
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
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Adults aged between 18 and 65 years.
- Diagnosed with Rheumatoid Arthritis (RA) by a rheumatologist.
- Disease in a stable phase (remission or low disease activity).
- Access to a smartphone or tablet and sufficient proficiency in using mobile applications.
- Cognitive sufficiency to provide written and verbal informed consent in Turkish.
Exclusion Criteria:
- Presence of acute RA flare-ups.
- Severe psychiatric diagnoses (e.g., psychosis, bipolar disorder, or severe major depression).
- Severe cognitive impairment or dementia.
- Pregnancy.
- Regular practice of meditation or mindfulness within the last 6 months.
- Participation in any other stress management program within the last 3 months.
- Receipt of mental health services within the last 6 months.
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: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Mobile Application Group
Participants in this group will receive a personalized 8-week yoga and meditation program via the Meditopia mobile application, in addition to their usual medical care.
|
The intervention consists of an 8-week individualized program.
It includes yoga sequences selected by a physiotherapist based on the patient's functional capacity and joint mobility.
It also includes mindfulness-based and emotion regulation-focused meditation content selected by a clinical psychologist.
Participants are expected to practice for 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week.The intervention is delivered through the Meditopia mobile application.
|
|
Žádný zásah: Control Group
Participants in this group will continue their usual medical follow-up and routine care without any structured digital mind-body intervention.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
Časové okno: Baseline (T0), Week 4 (T1), and Week 8 (T2).
|
Evaluated using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A).
The HADS-A is a 7-item self-report scale scored from 0 to 21.
Higher scores indicate a greater symptom burden of anxiety.
|
Baseline (T0), Week 4 (T1), and Week 8 (T2).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Perceived Stress Scale (PSS-10)
Časové okno: Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
Measured by the Perceived Stress Scale (PSS-10), a 10-item tool (scored 0-40) assessing how unpredictable or uncontrollable patients find their lives.
|
Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
|
Fatigue Severity Scale (FSS)
Časové okno: Baseline and Week 8
|
The Fatigue Severity Scale (FSS) is a 9-item self-report scale used to evaluate the impact of fatigue on daily functioning and social life.
Each item is scored on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree).
The total score is calculated as the mean of the 9 items, with a final score ranging from 1 to 7. A higher mean score indicates a greater severity of fatigue and a more significant impact of fatigue on the individual's daily activities.
|
Baseline and Week 8
|
|
Pittsburgh Sleep Quality Index (PSQI)
Časové okno: Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire used to assess sleep quality and disturbances over a one-month time interval.
It evaluates seven 'component' scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21.
A total global score of greater than 5 is generally used to indicate poor sleep quality.
Higher global scores represent poorer sleep quality and more significant sleep disturbances.
|
Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
|
Rheumatoid Arthritis Quality of Life (RAQOL)
Časové okno: Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
The Rheumatoid Arthritis Quality of Life (RAQOL) questionnaire is a disease-specific instrument designed to assess the quality of life in patients with rheumatoid arthritis using a needs-based model.
It consists of 30 items with a binary response format (Yes/No).
Each 'Yes' response is scored as 1, and each 'No' response is scored as 0. The total score ranges from 0 to 30, with higher scores representing a poorer quality of life and a greater negative impact of the disease on the individual's life.
The scale focuses on various domains, including mood, social life, hobbies, everyday tasks, and physical contact.
|
Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
|
Chronic Illness Self-Management (CISM) Scale
Časové okno: Baseline (T0) and Week 8 (T2)
|
The Chronic Illness Self-Management (CISM) scale is a 23-item tool designed to assess the self-management behaviors and perceptions of individuals living with chronic conditions.
It consists of four subscales: Self-Stigma (7 items), Coping with Stigma (5 items), Healthcare Effectiveness (5 items), and Treatment Adherence (6 items).
Each item is evaluated based on the patient's experience, providing a comprehensive measure of how well the individual manages the challenges associated with their illness.
Higher scores in specific domains indicate better self-management capabilities and adaptation to the chronic condition.
|
Baseline (T0) and Week 8 (T2)
|
|
Forced Vital Capacity (FVC)
Časové okno: Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
Quantitative measurement of respiratory function will be performed using a calibrated spirometer in accordance with the ATS/ERS standardization protocols.
FVC (expressed in Liters) will be recorded in a seated position to assess the presence and severity of extra-articular pulmonary involvement.
The best of at least three acceptable maneuvers will be used for analysis.
|
Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Časové okno: Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
Quantitative measurement of respiratory function assessed using a calibrated spirometer in accordance with the ATS/ERS standardization protocols.
FEV1 measures the volume of air exhaled in the first second of the forceful exhalation.
|
Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
|
FEV1/FVC Ratio
Časové okno: Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
The ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity, calculated from the spirometry maneuver to assess obstructive or restrictive pulmonary patterns.
|
Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
|
Peak Expiratory Flow (PEF)
Časové okno: Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
Quantitative measurement of respiratory function assessed using a calibrated spirometer in accordance with the ATS/ERS standardization protocols.
PEF measures the maximum speed of expiration.
|
Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
|
Visual Reaction Time (BlazePod)
Časové okno: Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
Visual reaction time will be measured using the BlazePod device, a portable visual-cognitive technology designed to assess response speed to light stimuli.
Simple and selective reaction time tasks will be performed where participants respond by touching or tapping the pod when it illuminates.
To ensure reliability, each participant will complete multiple trials (typically 5-10), and the average reaction time in milliseconds will be calculated after excluding outliers.
The testing procedure will be standardized regarding lighting conditions, distance, and participant positioning.
This measurement serves as a neurocognitive performance indicator to evaluate the systemic and cognitive effects of the intervention.
|
Baseline (T0), Week 4 (T1), and Week 8 (T2)
|
|
Total Direct Healthcare Costs (Partial Cost Analysis)
Časové okno: Baseline (T0) and Week 8 (T2)
|
A partial cost analysis will be conducted from a healthcare system perspective to evaluate the short-term economic impact of the digital intervention.
Data on healthcare resource utilization-including the number of planned or unplanned rheumatology/internal medicine outpatient visits, emergency room admissions, and the number and duration of hospitalizations-will be collected retrospectively for the 8-week period using a structured 'Healthcare Utilization Questionnaire'.
To calculate the total direct medical cost per patient, these frequency data will be multiplied by official unit costs derived from the current Social Security Institution (SGK) Health Implementation Communiqué (SUT) tariffs and supported by relevant cost-of-illness literature in Turkey.
This analysis aims to provide preliminary empirical evidence on the cost-effectiveness of integrating mobile mind-body interventions into the routine management of Rheumatoid Arthritis.
|
Baseline (T0) and Week 8 (T2)
|
|
System Usability Scale (SUS)
Časové okno: At the end of the 8-week intervention
|
The System Usability Scale will be administered only to participants in the intervention group to evaluate the usability, ease of use, and overall acceptability of the digital system used during the intervention.
The SUS is a validated 10-item questionnaire scored on a 5-point Likert scale.
Total scores range from 0 to 100, with higher scores indicating better perceived usability and user satisfaction with the system.
|
At the end of the 8-week intervention
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
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 (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
1. května 2027
Dokončení studie (Odhadovaný)
1. června 2027
Termíny zápisu do studia
První předloženo
15. května 2026
První předloženo, které splnilo kritéria kontroly kvality
18. června 2026
První zveřejněno (Aktuální)
24. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. června 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci pohybového aparátu
- Duševní poruchy
- Artritida
- Onemocnění kloubů
- Revmatická onemocnění
- Nemoci pojivové tkáně
- Autoimunitní onemocnění
- Onemocnění imunitního systému
- Symptomy chování
- Chování
- Onemocnění kůže a pojivové tkáně
- Úzkostné poruchy
- Artritida, revmatoidní
- Stres, psychologický
- Terapeutika
- Terapie mysli a těla
- Doplňkové terapie
- Duchovní terapie
- Terapie chování
- Psychoterapie
- Disciplíny a činnosti chování
- Relaxační terapie
- Rozjímání
Další identifikační čísla studie
- IUC-2025-641
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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 .