Yogic Breathing Exercise and Meditation for People With Spinal Cord Disorders
The goal of the study is to understand how well yogic breathing exercise and meditation improves breathing, fatigue, emotional well-being and quality of life in people with spinal cord disorders.
Aim 1. Evaluate the efficacy of an 8-week, virtual, coach-guided yogic breathing and meditation (YBM) program on QoL and mental health in people with spinal cord disorders.
This study will include completing several questionnaires 3 times, 8 weeks of participating in 2 sessions per week of yogic breathing exercise and meditation via Zoom and being interviewed once at the completion of the 8-week program.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
General Information You are being asked to take part in a research study. This research study is voluntary, meaning you do not have to take part in it. The procedures, risks, and benefits are fully described further in the consent form.
Purpose The purpose of the study is to understand how well yogic breathing exercise and meditation improves breathing, fatigue, and emotional well-being in people with spinal cord injury (SCI).
Duration & Visits You will complete several questionnaires (3 different times) that will take 30 minutes to complete each time, participate in 12-30-minute yogic breathing exercise and meditation sessions (over 8 weeks), complete a 25-minute interview and that you will be in the study for 2 months.
Overview of Procedures This study will include completing several questionnaires multiple times, 8 weeks of participating in 2 sessions per week of yogic breathing exercise and meditation via Zoom and being interviewed once.
Risks The most common risks include some tiredness and frustration while learning the yogic breathing exercise and meditation techniques. Loss of confidentiality is also a risk.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hon Yuen, PhD
- Número de teléfono: 12059346301
- Correo electrónico: yuen@uab.edu
Copia de seguridad de contactos de estudio
- Nombre: Adrian Smith, BS
- Número de teléfono: 12059348931
- Correo electrónico: adrian02@uab.edu
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Reclutamiento
- University of Alabama at Birmingham
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Investigador principal:
- Hon Yuen, PhD
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Contacto:
- Hon Yuen, PhD
- Número de teléfono: 2059346301
- Correo electrónico: yuen@uab.edu
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Contacto:
- Adrian Smith, BS
- Número de teléfono: 2059348931
- Correo electrónico: adrian02@uab.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- spinal cord disorders
- community-dwelling adults aged ≥ 18 years
- able to follow simple, three-step verbal instructions (e.g., close your eyes, open your mouth, close your mouth)
- access to the internet and an electronic device with videoconferencing capability
- able to set up virtual sessions with/without caregiver assistance
- sufficient English language proficiency to provide consent for study participation and complete self-report questionnaires
Exclusion Criteria:
- suicidal intent requiring emergency care
- bedridden with continuous use of noninvasive ventilation
- participating in weekly pulmonary PT, psychological therapy, or a clinical trial that could affect proposed study outcomes.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: yogic breathing and meditation
yogic breathing exercise and meditation exercise
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yogic breathing exercise and meditation exercise
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depressive symptoms as assessed by the PHQ-9
Periodo de tiempo: change from baseline in depressive symptoms at 8 and 16 weeks
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The Patient Health Questionnaire-9 (PHQ-9) consists of nine questions inquiring about symptoms experienced over the past two weeks, ranging from low energy and sleep issues to feelings of hopelessness and self-harm.
Each question is scored from 0 to 3, with a maximum total score of 27.
Higher scores indicate more severe depressive symptomology.
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change from baseline in depressive symptoms at 8 and 16 weeks
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|
Patient health questionnaire (PHQ-9)
Periodo de tiempo: baseline, post-program (8th week), and 16th week
|
The Patient Health Questionnaire-9 (PHQ-9) consists of nine questions inquiring about symptoms experienced over the past two weeks, ranging from low energy and sleep issues to feelings of hopelessness and self-harm.
Each question is scored from 0 to 3, with a maximum total score of 27.
Higher scores indicate more severe depressive symptomology.
|
baseline, post-program (8th week), and 16th week
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hon Yuen, PhD, University of Alabama at Birmingham
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades de la médula espinal
- Terapéutica
- Terapias de la mente-cuerpo
- Terapias complementarias
- Terapias espirituales
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Terapia de relajación
- Meditación
Otros números de identificación del estudio
- IRB-300011535 A
- UAB (Otro identificador: UAB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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