- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ruhat Tilki, PhD Candidate
- Número de telefone: +90 553 514 98 10
- E-mail: ruhat.tilki@fbu.edu.tr
Estude backup de contato
- Nome: Ayda Kebapçı, Assc. Prof.
- Número de telefone: +90 536 858 91 14
- E-mail: akebapci@ku.edu:tr
Locais de estudo
-
-
Sancaktepe
-
Istanbul, Sancaktepe, Turquia (Türkiye), 34785
- Şehit Prof. Dr. İlhan Varank Sancaktepe Eğitim ve Araştırma Hastanesi
-
Contato:
- Ruhat Tilki, Ph.D. Candidate
- Número de telefone: +90 553 514 98 10
- E-mail: ruhat.tilki@fbu.edu.tr
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Inspiratory and Expiratory Airflow Volume and Rate
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
State and Trait Anxiety Levels
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Processos Patológicos
- Manifestações Neurocomportamentais
- Distúrbios Perceptivos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor, Pós-operatório
- Agnosia
- Complicações pós-operatórias
- Terapêutica
- Terapias complementares
- Modalidades de fisioterapia
- Reabilitação
- Terapia, tecido mole
- Manipulações músculo -esqueléticas
- Acupressão
Outros números de identificação do estudo
- 23.2026fbu
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .