- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07771751
The Effect of Acupressure Application on Respiratory Performance and Pain Levels in Adult Patients Undergoing Cardiac Surgery
The Effect of Acupressure Application on Respiratory Performance and Pain Levels in Adult Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Cardiovascular diseases remain a major global health burden. While open-heart surgery is a vital treatment for many cardiac conditions, it is characterized by a high risk of complications and a long recovery period. Postoperative pulmonary complications, including hypoxemia, pneumonia, atelectasis, and respiratory failure, are prevalent among these patients. To prevent these issues and restore lung expansion, the regular use of an incentive spirometer is a standard and essential component of nursing care in the cardiovascular surgical intensive care unit.
However, severe postoperative pain restricts patients' ability to take deep breaths, which significantly reduces the effectiveness of incentive spirometry and increases the risk of lung complications. Furthermore, pharmacological agents commonly used for pain management can cause adverse effects like respiratory depression. This has directed nursing practice toward non-pharmacological, complementary symptom management strategies.
Acupressure is a non-invasive complementary therapy rooted in traditional medicine, involving the application of physical pressure to specific acupoints. Current literature indicates that stimulating specific points, such as LU7 (Lieque) and PC6 (Neiguan), can regulate autonomic nervous system activities, increase parasympathetic tone, and improve overall respiratory function. Although its potential in general symptom management is recognized, clinical evidence regarding the direct impact of acupressure on respiratory performance in post-cardiac surgery intensive care patients remains highly limited. This study aims to address this gap by determining the physiological and clinical effects of acupressure on both pain levels and respiratory capacity in this specific patient population.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ruhat Tilki, PhD Candidate
- Número de teléfono: +90 553 514 98 10
- Correo electrónico: ruhat.tilki@fbu.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Ayda Kebapçı, Assc. Prof.
- Número de teléfono: +90 536 858 91 14
- Correo electrónico: akebapci@ku.edu:tr
Ubicaciones de estudio
-
-
Sancaktepe
-
Istanbul, Sancaktepe, Turquía (Türkiye), 34785
- Şehit Prof. Dr. İlhan Varank Sancaktepe Eğitim ve Araştırma Hastanesi
-
Contacto:
- Ruhat Tilki, Ph.D. Candidate
- Número de teléfono: +90 553 514 98 10
- Correo electrónico: ruhat.tilki@fbu.edu.tr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Aged 18 years and older.
- Undergoing cardiac surgery for the first time.
- Extubated and hemodynamically stable in the postoperative period.
- A Glasgow Coma Scale (GCS) score of 15.
- Absence of arterial or venous catheters, incisions, hematomas, ecchymoses, or any skin lesions/deformities at the acupressure application sites.
- No analgesic medication administered within the last four hours.
- No known neuromuscular diseases that could affect respiratory muscle strength or performance.
- Ability to speak Turkish and absence of any communication barriers.
Exclusion Criteria:
- Development of postoperative complications (e.g., severe arrhythmia, need for re-intubation, active bleeding).
- Receiving sedation in the intensive care unit.
- Presence of chronic pain syndrome or regular use of opioids/analgesics.
- Known psychiatric disorders.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Acupressure Group
Acupressure will be applied to the LI4 (Hegu) (on the dorsum of the hand, between the 1st and 2nd metacarpal bones), LU7 (Lieque) (on the radial side of the forearm, approximately 3.75 cm [1.5 cun] above the wrist crease), and PC6 (Neiguan) (on the palmar aspect of the forearm, approximately 5 cm [2 cun] above the wrist crease) acupoints (Appendix-4), which are reported in the literature to positively affect pain and the respiratory system.
The intervention will be performed by a researcher holding an acupressure certification.
Using the thumb, index finger, or middle finger, pressure will be applied to the identified LI4, LU7, and PC6 points to a depth of 1 to 1.5 cm for 10 seconds.
After a 2-second release, the pressure will be continued for 2 minutes (Düzel et al., 2023; Vanzini et al., 2021; Narimani et al., 2018).
|
Acupressure will be applied to the LI4 (Hegu) (on the dorsum of the hand, between the 1st and 2nd metacarpal bones), LU7 (Lieque) (on the radial side of the forearm, approximately 3.75 cm [1.5 cun] above the wrist crease), and PC6 (Neiguan) (on the palmar aspect of the forearm, approximately 5 cm [2 cun] above the wrist crease) acupoints (Appendix-4), which are reported in the literature to positively affect pain and the respiratory system.
The intervention will be performed by a researcher holding an acupressure certification.
Using the thumb, index finger, or middle finger, pressure will be applied to the identified LI4, LU7, and PC6 points to a depth of 1 to 1.5 cm for 10 seconds.
After a 2-second release, the pressure will be continued for 2 minutes (Düzel et al., 2023; Vanzini et al., 2021; Narimani et al., 2018).
The study will use a triflow device, which consists of three separate chambers and a breathing tube with a mouthpiece. The chambers contain colored balls corresponding to flow volumes of 600, 900, and 1200 mL/sec, respectively. An inspiratory flow of 600 mL/sec raises the ball in the first chamber, an inspiratory flow of 900 mL/sec raises the ball in the second chamber, and an inspiratory flow of 1200 mL/sec raises the ball in the third chamber (Amin et al., 2021). To measure inspiratory flow rate and volume, patients will be instructed to seal their lips tightly around the triflow mouthpiece, ensuring no gaps remain. Patients will be asked to take a deep and slow breath to raise the balls. Subsequently, to measure expiratory flow rate and volume, they will be asked to remove the mouthpiece, hold their breath for 3 to 5 seconds, and then exhale normally (Gökçe et al., 2025). |
|
Comparador falso: Placebo Acupressure Group
In the placebo acupressure group, all procedural steps will be performed in the exact same manner as in the true acupressure group.
However, very light pressure will be applied to sham areas located 1.5 cm away from the LI4, LU7, and PC6 acupoints that do not fall on any meridian.
Using the thumb, index finger, or middle finger, this very light pressure will be applied to each point for 10 seconds, followed by a 2-second rest, continuing for 2 minutes per point.
The application will be performed bilaterally and will take an average of 15 minutes.
Following the procedure, a 20-minute resting period will be provided.
|
The study will use a triflow device, which consists of three separate chambers and a breathing tube with a mouthpiece. The chambers contain colored balls corresponding to flow volumes of 600, 900, and 1200 mL/sec, respectively. An inspiratory flow of 600 mL/sec raises the ball in the first chamber, an inspiratory flow of 900 mL/sec raises the ball in the second chamber, and an inspiratory flow of 1200 mL/sec raises the ball in the third chamber (Amin et al., 2021). To measure inspiratory flow rate and volume, patients will be instructed to seal their lips tightly around the triflow mouthpiece, ensuring no gaps remain. Patients will be asked to take a deep and slow breath to raise the balls. Subsequently, to measure expiratory flow rate and volume, they will be asked to remove the mouthpiece, hold their breath for 3 to 5 seconds, and then exhale normally (Gökçe et al., 2025).
In the placebo acupressure group, all procedural steps will be performed in the exact same manner as in the true acupressure group.
However, very light pressure will be applied to sham areas located 1.5 cm away from the LI4, LU7, and PC6 acupoints that do not fall on any meridian.
Using the thumb, index finger, or middle finger, this very light pressure will be applied to each point for 10 seconds, followed by a 2-second rest, continuing for 2 minutes per point.
The application will be performed bilaterally and will take an average of 15 minutes.
Following the procedure, a 20-minute resting period will be provided.
|
|
Comparador activo: control group
Patients in this group will receive only standard postoperative nursing care and routine incentive spirometry exercises.
|
The study will use a triflow device, which consists of three separate chambers and a breathing tube with a mouthpiece. The chambers contain colored balls corresponding to flow volumes of 600, 900, and 1200 mL/sec, respectively. An inspiratory flow of 600 mL/sec raises the ball in the first chamber, an inspiratory flow of 900 mL/sec raises the ball in the second chamber, and an inspiratory flow of 1200 mL/sec raises the ball in the third chamber (Amin et al., 2021). To measure inspiratory flow rate and volume, patients will be instructed to seal their lips tightly around the triflow mouthpiece, ensuring no gaps remain. Patients will be asked to take a deep and slow breath to raise the balls. Subsequently, to measure expiratory flow rate and volume, they will be asked to remove the mouthpiece, hold their breath for 3 to 5 seconds, and then exhale normally (Gökçe et al., 2025). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Inspiratory and Expiratory Airflow Volume and Rate
Periodo de tiempo: Evaluated before and immediately after the intervention (acupressure, placebo acupressure, or standard triflow exercise).
|
Airflow rate (mL/sec) and volume (mL) will be measured using a three-chamber incentive spirometer (triflow).
The average of the three highest values obtained during five inspirations and five expirations will be recorded.
|
Evaluated before and immediately after the intervention (acupressure, placebo acupressure, or standard triflow exercise).
|
|
Postoperative Pain Severity
Periodo de tiempo: Evaluated before and immediately after the intervention.
|
Pain severity will be assessed using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
|
Evaluated before and immediately after the intervention.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
State and Trait Anxiety Levels
Periodo de tiempo: State and Trait anxiety is evaluated right before and 20 minutes after the intervention.
|
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), which consists of 40 items on a 4-point Likert scale.
Scores range from 20 to 80, with higher scores indicating higher anxiety levels.
|
State and Trait anxiety is evaluated right before and 20 minutes after the intervention.
|
|
Chest Tube Removal Time
Periodo de tiempo: Up to hospital discharge, an average of 7 days.
|
The duration from the end of the surgical procedure until the removal of the chest tube.
This outcome will be measured and reported in hours.
|
Up to hospital discharge, an average of 7 days.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ayda Kebapçı, Assc. Prof., Koc University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Procesos Patológicos
- Manifestaciones neuroconductuales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Agnosia
- Complicaciones Postoperatorias
- Terapéutica
- Terapias complementarias
- Modalidades de fisioterapia
- Rehabilitación
- Terapia, tejido blando
- Manipulaciones musculoesqueléticas
- Acupresión
Otros números de identificación del estudio
- 23.2026fbu
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .