Postoperative PainNCT07771751
The Effect of Acupressure Application on Respiratory Performance and Pain Levels in Adult Patients Undergoing Cardiac Surgery
A study testing Acupressure and Incentive spirometry in people with Postoperative Pain and Cardiac Surgery, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Cardiac Surgery, Postoperative Complications
- What is being tested?
- Acupressure and Incentive spirometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Sep 2026to 21 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Şehit Prof. Dr. İlhan Varank Sancaktepe Eğitim ve Araştırma Hastanesi
Istanbul, Sancaktepe, 34785
Ruhat Tilki, Ph.D. Candidate, +90 553 514 98 10, ruhat.tilki@fbu.edu.tr
About this study
Official title: The Effect of Acupressure Application on Respiratory Performance and Pain Levels in Adult Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Acupressure, Placebo Acuprresure, Incentive spirometry
- Keywords
- Respiratory Performance, Pain Management, Nursing Care, acupressure, cardiac surgery
- Medical subject headings
- Pain, Postoperative, Postoperative Complications, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureBehavioural
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).
Placebo AcuprresureBehavioural
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.
Incentive spirometryBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Group | Experimental | 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). Receives: Behavioral: Acupressure; Behavioral: Incentive spirometry |
| Placebo Acupressure Group | Sham comparator | 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. Receives: Behavioral: Placebo Acuprresure; Behavioral: Incentive spirometry |
| control group | Active comparator | Patients in this group will receive only standard postoperative nursing care and routine incentive spirometry exercises. Receives: Behavioral: Incentive spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory and Expiratory Airflow Volume and Rate
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.
Measured: Evaluated before and immediately after the intervention (acupressure, placebo acupressure, or standard triflow exercise).
Postoperative Pain Severity
Pain severity will be assessed using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Measured: Evaluated before and immediately after the intervention.
Secondary outcomes (2)
State and Trait Anxiety Levels
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.
Measured: State and Trait anxiety is evaluated right before and 20 minutes after the intervention.
Chest Tube Removal Time
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.
Measured: Up to hospital discharge, an average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start21 Sep 2026 (estimated)
- Primary completion21 Sep 2027 (estimated)
- Study completion21 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruhat Tilki, Fenerbahce University
- Investigators
- Ayda Kebapçı, Assc. Prof., Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771751
- Sponsor's protocol ID
- 23.2026fbu
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the published article will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure Application on Respiratory Performance and Pain Levels in Adult Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07771751
- Acronym / sponsor ID
- 23.2026fbu
- Keywords
- Respiratory Performance, Pain Management, Nursing Care, acupressure, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 21 Sep 2027 (estimated)
- Study completion
- 21 Sep 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group | Experimental | Behavioral: Acupressure, Behavioral: Incentive spirometryAcupressure 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). |
| Placebo Acupressure Group | Sham comparator | Behavioral: Placebo Acuprresure, Behavioral: Incentive spirometryIn 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. |
| control group | Active comparator | Behavioral: Incentive spirometryPatients in this group will receive only standard postoperative nursing care and routine incentive spirometry exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureAcupressure 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). | Behavioural | Acupressure Group |
| Placebo AcuprresureIn 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. | Behavioural | Placebo Acupressure Group |
| Incentive spirometryThe 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). | Behavioural | Acupressure Group, Placebo Acupressure Group, control group |
Primary outcome
Inspiratory and Expiratory Airflow Volume and Rate
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.
Postoperative Pain Severity
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).
2 secondary outcomes
State and Trait Anxiety Levels
Time frame: State and Trait anxiety is evaluated right before and 20 minutes after the intervention.
Chest Tube Removal Time
Time frame: Up to hospital discharge, an average of 7 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the published article will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayda Kebapçı, Assc. Prof. principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and Incentive spirometry in people with Postoperative Pain and Cardiac Surgery, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruhat Tilki, PhD Candidate (+90 553 514 98 10, ruhat.tilki@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory and Expiratory Airflow Volume and Rate (time frame: Evaluated before and immediately after the intervention (acupressure, placebo acupressure, or standard triflow exercise).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.