Breathwork Training Reduces Anxiety In Outpatient Gastrointestinal Procedures
Pre-procedural Breath Training Reduces Anxiety and Physiologic Stress in Outpatient Gastrointestinal Procedures: A Controlled Clinical Study
Descripción general del estudio
Descripción detallada
Preoperative anxiety is a well-documented phenomenon that affects up to 80% of surgical patients and is particularly prevalent in outpatient procedures, where patients have limited time to acclimate to the medical environment. This heightened anxiety can lead to increased sympathetic nervous system activation, which elevates heart rate (HR), blood pressure (BP), and respiratory rate (RR), potentially complicating anesthesia induction and recovery.
Pharmaceutical agents such as benzodiazepines and opioids are commonly used to mitigate this anxiety. However, these medications are associated with side effects such as respiratory depression, delayed recovery, and increased cost. Non-pharmacologic interventions, including guided imagery, music therapy, and breathwork, have been investigated as adjunctive therapies for anxiety reduction with varying degrees of success.
Breathwork, particularly slow-paced breathing at a rate of six breaths per minute, has been shown to increase parasympathetic activity, improve autonomic balance and reduce physiologic stress markers. This study evaluates a structured, multisensory breath training intervention designed to facilitate paced breathing in patients undergoing outpatient gastrointestinal procedures.
In this prospective controlled study, 30 patients undergoing outpatient gastrointestinal (GI) procedures received a seven-minute pre-procedural breath training intervention and were compared to 30 matched retrospective controls. Physiologic parameters including heart rate (HR), blood pressure (BP), and respiratory rate (RR) were measured pre- and post-intervention. Recovery time was also assessed.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Jupiter, Florida, Estados Unidos, 33458
- Jupiter Medical Center Outpatient Surgical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 30 consecutive patients
- aged 18-85
- undergoing outpatient GI procedure (colonoscopy, upper GI endoscopy)
- under monitered anesthesia care
Exclusion Criteria:
- pregnancy
- pacemaker
- anti-arhythmic medications
- severe acute illness
- sensitivity or previous problems with general anesthesia
- fragrance sensitivity
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Arm 1- 30 sequential GI procedure outpatients
this arm receives the noninvasive, paced breathwork device breathwork intervention for 7 minutes and physiogic data is charted by the nursing staff before and after the intervention.
The patient therefore acts as their own control.
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The intervention is a noninvasive vibratory breathwork strategy, paced to 6 times per minute, and utilized for 7 minutes, in the preprocedure holding room.
This is meant to cue the patient to breath more slowly and calm the patient down before the procedure without pharmaceutical intervention.
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Sin intervención: retrospective chart review of 30 recent patients comparing recovery room times- no intervention
this arm did not have an intervention- therefore there is only one set of vitals in the chart.
this arm utilized 30 sequential patients for chart review of recovery room times only
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physiologic parameters of blood pressure
Periodo de tiempo: 7 minutes
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Evaluated via standard automated clinical monitors.
The metric reported is the mean change in blood pressure (in mmhg), from the pre-training baseline to the post-training 7-minute mark.
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7 minutes
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1. Physiologic parameters of heart rate
Periodo de tiempo: 7 minutes
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Evaluated via standard automated clinical monitors.
The metric reported is the mean change in heart rate in beats per minute, from the pre-training baseline to the post-training 7-minute mark.
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7 minutes
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Physiologic parameter of respiratory rate
Periodo de tiempo: 7 minutes
|
Evaluated via standard automated clinical monitors.
The metric reported is the mean change in respiratory rate in breaths per minute, from the pre-training baseline to the post-training 7-minute mark.
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7 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Length of Stay in postprocedure recovery room
Periodo de tiempo: From peri-procedure (recovery room admission through discharge home up to 120 minutes)
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The recovery room duration is defined as the exact time elapsed (in minutes) from the moment the patient enters the recovery room post-procedure until the formal medical discharge criteria are met and the patient is released home.
The metric reported represents the mean difference in recovery time between the prospective intervention group and the 30 randomized retrospective control patients.
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From peri-procedure (recovery room admission through discharge home up to 120 minutes)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Hernandez, MD, Jupiter Medical Center Outpatient Surgical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- Sterling IRB (ID #13491)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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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