- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07646002
Effectiveness of Balloon Blowing and Deep Breathing Exercise on Increasing Peripheral Oxygen Saturation in Patients With Chronic Obstructive Pulmonary Disease
This study aims to determine the effect of Balloon Blowing and Deep Breathing Exercise on Increasing Peripheral Oxygen Saturation in Patients with Chronic Obstructive Pulmonary Disease. The main question it aims to answer is:
1. What is the effect of balloon blowing breathing exercise on peripheral oxygen saturation in Chronic Obstructive Pulmonary Disease patients? Participants performed the exercise on the day agreed upon with the researcher. Respondents performed balloon-blowing breathing exercises twice daily for 7 days. These exercises consisted of deep breathing exercises followed by a slow balloon-blowing technique in three cycles per session, with a 1-minute rest interval between cycles. Each cycle included a deep breath for 3-4 seconds, a breath hold for 2-3 seconds, and a slow breath into the balloon for 5-8 seconds, repeated four times. Oxygen saturation was measured after the intervention on the seventh day to assess the effect of the exercise on peripheral oxygen saturation.
Researchers compared the intervention and control groups to determine whether there was a significant difference between respondents who performed deep breathing exercises and balloon-blowing (intervention) and those who performed only deep breathing exercises (control).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The research process was guided by the CONSORT Statement for RCTs. The process involved registration, allocation, follow-up, and analysis. The recruitment process began with a feasibility assessment for potential respondents. This process was carried out when the patient conducted a phase 2 pulmonary rehabilitation evaluation.
Researchers initially reviewed patient data through medical records, reviewing ID, color code, age, gender, medical history, patient condition, and location of residence. Patients' communication skills were assessed during the evaluation.
The inclusion criteria for this study were patients aged 18-60 years, diagnosed with mild to moderate COPD, or with other medical conditions but a history of COPD, able and calm to follow instructions to inhale using the balloon blowing technique, and willing to be studied with informed consent. Exclusion criteria included patients with severe shortness of breath, patients on respiratory support, and abnormal hemoglobin levels. Dropout criteria included discontinuation of the study and respondents not undergoing the appropriate intervention. The collected respondents were then randomly assigned using envelopes, dividing them into two groups: 23 respondents in the intervention group and 23 respondents in the control group.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Special Region of Aceh
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Banda Aceh, Special Region of Aceh, Indonesia, 32126
- dr. Zainoel Abidin Regional General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged 18-60 years, diagnosed with mild to moderate COPD, or with other medical conditions but a history of COPD, able and calm to follow instructions to inhale using the balloon blowing technique, and willing to be studied with informed consent.
Exclusion Criteria:
- Patients with severe shortness of breath, patients on respiratory support, and abnormal hemoglobin levels. Dropout criteria included discontinuation of the study and respondents not undergoing the appropriate intervention.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Group
Performed Balloon-blowing and Deep breathing exercises
|
Respondents performed balloon-blowing breathing exercises twice daily for 7 days.
These exercises consisted of deep breathing exercises followed by a slow balloon-blowing technique in three cycles per session, with a 1-minute rest interval between cycles.
Each cycle included a deep breath for 3-4 seconds, a breath hold for 2-3 seconds, and a slow breath into the balloon for 5-8 seconds, repeated four times.
|
|
Experimental: Control Group
Performed only deep breathing exercises
|
The participants performed deep breathing exercises twice daily for 7 days.
The exercises consisted of three cycles of deep breathing only per session, with a 1-minute rest interval between cycles.
Each cycle included a deep breath in for 3-4 seconds, a breath hold for 2-3 seconds, and a slow exhalation for 5-8 seconds, repeated four times.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peripheral Oxygen Saturation
Periodo de tiempo: Day 1 & Day 7
|
Peripheral oxygen saturation was measured using a Braun brand pulse oximeter after the intervention on the first and seventh days to assess the effect of the exercise.
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Day 1 & Day 7
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Chairul Huda, Master & Postgraduate Program, Indonesia University
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 770/Litbang
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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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