Şehit Prof. Dr. İlhan Varank Sancaktepe Eğitim ve Araştırma Hastanesi
Istanbul, Sancaktepe, 34785, Turkey (Türkiye)
NCT Number: NCT07771751
The purpose of this randomized controlled trial is to evaluate the effect of acupressure on respiratory performance and pain levels in adult patients who have undergone open-heart surgery. Pulmonary complications and severe pain are common after cardiac surgery, often limiting the effectiveness of standard deep breathing exercises such as incentive spirometry. This study investigates whether applying acupressure-a non-invasive complementary therapy-can help manage postoperative pain and improve respiratory capacity. By potentially reducing pain without the respiratory side effects associated with pharmacological medications, acupressure may enable patients to perform their breathing exercises more effectively and support their overall recovery.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Istanbul, Sancaktepe, 34785, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Ayda Kebapçı, Assc. Prof.
CONTACT
Ruhat Tilki, PhD Candidate
CONTACT
Fenerbahce University
Other
The Effect of Acupressure Application on Respiratory Performance and Pain Levels in Adult Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05575700
Acute Pain, Agnosia
Brøndby, Denmark
View Trial DetailsNCT06342076
Agnosia, Analgesia
Istanbul, Basaksehir, Turkey (Türkiye)
View Trial DetailsNCT06425601
Agnosia, Nervous System Diseases
Ljubljana, Slovenia
View Trial DetailsNCT05432011
Acute Pain, Agnosia
Rome, Italy
View Trial Details