NCT07771751

Brief 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. 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 Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
12mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2027

Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 11, 2026

Last Update Submit

August 14, 2026

Conditions

Keywords

Respiratory PerformancePain ManagementNursing Careacupressurecardiac surgery

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    Evaluated before and immediately after the intervention.

Secondary Outcomes (2)

  • State and Trait Anxiety Levels

    State and Trait anxiety is evaluated right before and 20 minutes after the intervention.

  • Chest Tube Removal Time

    Up to hospital discharge, an average of 7 days.

Study Arms (3)

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).

Behavioral: AcupressureBehavioral: 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.

Behavioral: Placebo AcuprresureBehavioral: Incentive spirometry

control group

ACTIVE COMPARATOR

Patients in this group will receive only standard postoperative nursing care and routine incentive spirometry exercises.

Behavioral: Incentive spirometry

Interventions

AcupressureBEHAVIORAL

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 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.

Placebo Acupressure Group

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).

Acupressure GroupPlacebo Acupressure Groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şehit Prof. Dr. İlhan Varank Sancaktepe Eğitim ve Araştırma Hastanesi

Istanbul, Sancaktepe, 34785, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePostoperative ComplicationsAgnosia

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Ayda Kebapçı, Assc. Prof.

    Koç University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruhat Tilki, PhD Candidate

CONTACT

Ayda Kebapçı, Assc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In the study, patient blinding will be achieved by using placebo acupressure. However, since the same researcher will both administer the intervention and monitor the patients, blinding of the researcher cannot be achieved. Therefore, the study has been designed as a single-blind trial.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 18, 2026

Study Start (Estimated)

September 21, 2026

Primary Completion (Estimated)

September 21, 2027

Study Completion (Estimated)

September 21, 2027

Last Updated

August 18, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data that underlie the results reported in the published article will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available beginning 6 months and ending 36 months following article publication.
Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal for secondary analyses. Requests should be directed to the central contact person via email.

Locations