- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411417
Combined Acupressure Effects on Post-Thoracotomy Pain and Lung Volume
The Effects of Acupressure Combination on Post-Thoracotomy Pain and Lung Volume During Rest, Breathing-Coughing Exercises: A Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Many non-drug applications such as music therapy, transcutaneous electrical nerve stimulation, cryotherapy, acupuncture, electroacupuncture are used in pain management after thoracic surgery and to reduce analgesic use. Acupuncture is an application that provides the balance of energy flow (Qi) on meridians with thin needles placed at certain points of the body, which has been widely applied in China for more than 4000 years. Factors such as trauma and surgical incision disrupt the energy flow between meridians and cause problems in organ groups where meridians are effective. Acupuncture is accepted as an application that helps to balance this energy flow. Acupressure application, which is included in nursing practices, is a holistic non-pharmaceutical application based on acupuncture. Acupressure is a holistic treatment method that includes manual and noninvasive methods that provide stimulation to acupuncture points with pressure instead of needle stimulation. The point where acupressure will be applied is selected among the acupuncture points on the relevant meridian according to the problem existing in the individual. In acupressure application, pressure can be applied to a single point or more than one point consecutively.In acupressure application, it is reported that pressure can be applied to a single point, as well as stimulating multiple points consecutively will increase the desired effect. As the preferred acupuncture key points on the meridians, points on the hand, finger, wrist, palm, elbow, knee, and feet are often preferred. Acupressure tactilely reduces the sensation of pain by stimulating Aβ nerve fibres; increases the pain threshold by supporting the release of endogenous opioids; regulates the transmission of pain signals by secreting serotonin and norepinephrine, which are neurotransmitters responsible for the regulation of pain. In a randomised controlled study, the efficacy of acupressure in the treatment of postoperative pain in patients undergoing thoracoscopic surgery was examined. The participants in the experimental group were acupressured three times a day for two days at LI11, LU7, LU9, LU5, LU1, LU2, TE5, TE6, PC4, PC6 and LI4 acupressure points. In the control group, routine treatment of the clinic was applied and acupressure was not applied. After acupressure application, the pain score of the experimental group was found to be lower compared to the control group (p < 0.001). Similarly, it is reported in the literature that the use of acupressure is one of the best options for the relief of postoperative pain. It is also reported in the literature that acupressure can effectively improve lung function, dyspnoea and quality of life of patients with pneumonia.
Non-drug applications planned for the expected pain in the early postthoracotomy period are important in terms of reducing respiratory complications, improving the quality of pain management and supporting patients. When the literature is examined, there is no study examining the effect of acupressure on pain and lung volume during deep breathing and cough exercises, which have an important role in maintaining and improving lung volume after thoracotomy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Özgül Aydemir, Doctor
- Phone Number: +905435326567
- Email: ozgul6761@gmail.com
Study Contact Backup
- Name: Öykü Kara, Specialist
- Phone Number: +905546669614
- Email: oyku.kara@iuc.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34067
- Recruiting
- Özgül Aydemir
-
Contact:
- Özgül Aydemir, Doctor
- Phone Number: +905435326567
- Email: ozgul6761@gmail.com
-
Contact:
- Öykü Kara, Specialist
- Phone Number: +905546669614
- Email: oyku.kara@iuc.edu.tr
-
Principal Investigator:
- İlhan Öztekin, Professor
-
Sub-Investigator:
- Seher Deniz Öztekin, Professor
-
Sub-Investigator:
- Nurgül Yurtseven, Professor
-
Sub-Investigator:
- Tamer Okay, Professor
-
Sub-Investigator:
- Hilal Yavuzel, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Underwent thoracotomy
- Undergoing thoracic surgery for the first time
- Classified as ASA (American Society of Anesthesiology) physical status I, II and III
- Presence of a drain upon admission to the intensive care unit
- Conscious, oriented, and cooperative
- Provided verbal and written informed consent after receiving information about the study
Exclusion Criteria:
- Intubated
- Persistent anxiety before the surgery
- Diagnosed with panic disorder
- Chemotherapy within the last 6 months
- Diagnosed psychiatric illness or mental health problems
- Presence of edema
- Intraoperative or postoperative complications
- Non-Turkish speaking, or presence of hearing or visual impairment
- Body mass index (BMI) greater than 30
- Participation in another clinical trial during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupressure group
Patients meeting the research criteria were included in the experimental group according to the randomisation table. The acupressure combination will be applied to the LI11, LU7, LU9, LU5, LU1, LU2, TE5, TE6,PC4, PC6 and LI4 points 2, 6 and 24 hours after surgery. Applications will last 1 minute for each point. Applications will last 1 minute for each point. Patients in this group will continue to receive routine clinical treatment and care. The patients' pain level during rest, breathing, coughing and mobilisation before surgery and 2, 6 and 24 hours after surgery, blood pressure, respiratory rate, respiratory count, SpO2 values, and lung volume before surgery and 24 hours after surgery will be measured and recorded using triflow. Additionally, the individuals' breathing and coughing exercise status will be assessed within the first 24 hours after surgery. These stages will also be carried out in a similar manner in the control group without any intervention. |
A series of acupressure applications
|
|
No Intervention: Control group
Patients meeting the study criteria were included in the control group according to the randomisation table. Patients in this group will continue to receive routine clinical treatment and care. The patients' pain level during rest, breathing, coughing and mobilisation before surgery and 2, 6 and 24 hours after surgery, blood pressure, respiratory rate, respiratory count, SpO2 values, and lung volume before surgery and 24 hours after surgery will be measured and recorded using triflow. Additionally, individuals' breathing and coughing exercise status will be assessed within the first 24 hours after surgery. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain after thoracotomy
Time Frame: The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery,
|
Pain after thoracotomy
|
The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery,
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain during rest
Time Frame: The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery
|
Pain during rest
|
The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain during respiratory exercise
Time Frame: The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery
|
Pain during respiratory exercise
|
The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery
|
|
Pain during coughing exercise
Time Frame: The patient's visual analogue scale pain score at (VAS) 2, 6, and 24 hours post-surgery
|
Pain during coughing exercise
|
The patient's visual analogue scale pain score at (VAS) 2, 6, and 24 hours post-surgery
|
|
Lung function
Time Frame: Preoperative triflow measurement results and postoperative 24-hour triflow measurement results (cc/s)
|
Lung function
|
Preoperative triflow measurement results and postoperative 24-hour triflow measurement results (cc/s)
|
|
Total amount of analgesics used
Time Frame: The total amount of analgesic administered to the patient at the 2nd, 6th and 24th postoperative hours will be recorded.
|
Total amount of analgesics used
|
The total amount of analgesic administered to the patient at the 2nd, 6th and 24th postoperative hours will be recorded.
|
|
Pain before thoracotomy
Time Frame: The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery
|
Pain before thoracotomy
|
The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: İlhan Öztekin, Professör, Yeditepe University
- Study Director: Seher Deniz Öztekin, Professör, Doğuş University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-95961207-202.3.02-5421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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