- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06681519
The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia (LA)
Background: Local anaesthesia surgeries are outpatient procedures that allow patients to go home the same day. However, these surgeries often cause pain and anxiety for patients. Opioids are commonly used for pain management, but concerns about allergies and side effects have driven the need for alternative, safer treatments. Traditional Chinese medicine emphasizes the meridian system, which regulates qi, energy, and blood flow in the body. Stimulating acupoints on these meridians may help alleviate various ailments. This study examines whether acupressure can reduce pain and anxiety and improve physiological outcomes in patients undergoing local anaesthesia.
Objective: To assess the effectiveness of acupressure on reducing pain and anxiety, and enhancing physiological outcomes in local anaesthesia patients.
Methods: A randomized controlled trial was conducted with adult patients under local anaesthesia. The experimental group received acupressure at specific points (Hegu LI4 and Shenmen HT7), while the control group received standard care. Pain, anxiety, and autonomic function were measured before and after the intervention using IBMSPSS version 20.0 for analysis.
Study Overview
Status
Detailed Description
Summary:
Outpatient surgeries with local anesthesia allow patients to return home the same day but can often lead to pain and anxiety. Although opioids are frequently used for pain management, concerns about allergies and side effects prompt the search for safer alternatives. Traditional Chinese medicine (TCM) suggests that stimulating acupoints along the body's meridian system can promote the flow of qi, energy, and blood, potentially alleviating various ailments. This study investigates whether acupressure can effectively reduce pain, anxiety, and improve physiological outcomes in patients undergoing local anesthesia.
Objective: To determine if acupressure can reduce pain and anxiety while improving physiological outcomes in patients receiving local anesthesia.
Methods: A randomized controlled trial was conducted with adults undergoing local anesthesia. The experimental group received acupressure on the Hegu (LI4) and Shenmen (HT7) points, while the control group received standard care. Pain, anxiety, and autonomic function were measured before and after the intervention, analyzed using IBM SPSS version 20.0.
Additional Context: Distraction techniques, including VR, music, videos, breathing exercises, vibration stimulation, and acupressure with hand-held pressure balls, have been shown to help patients manage pain and anxiety during procedures. This study uses acupressure and pressure balls to create a positive psychological model for managing stress, fear, and anxiety, potentially helping patients adopt a better mental approach toward surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taipei, Taiwan, Taiwan, 111
- Yu Jui Feng
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Taipei, Taiwan, Taiwan, 111
- YuJui Feng
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
1. The acceptance conditions of the subject must meet:
- Adults (20-64 years old).
- Mainly patients receiving local anesthesia.
- Those who have no abnormal limb sensation and good skin integrity, and can perform normal acupoint pressure.
- Those who are willing to participate in this study and can communicate in Mandarin and Taiwanese.
2. Exclusion conditions:
- Those who have taken painkillers before surgery.
- The surgical site is already inflamed.
- Those diagnosed with mental illness and cognitive impairment.
- Heart disease and arrhythmia (pacemaker).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Group 1
Acupoint pressure Group 1relieves pain and anxiety pain .
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Interventions Group 1 - Acupoint Pressure Group 2 - Hand-Held Pressure Ball Control Group 3 - Conventional Treatment Other Names: Stress ball holding, acupoint pressure, conventional treatment Description: Before the intervention, subjects completed a pre-test. Afterward, they assumed a relaxed, comfortable lying position. The examiner applied acupoint pressure at four specific points: Hegu (LI4), Shenmen (HT7), Neiguan (PC6), and Zhongchong (PC9). The technique involves using the thumb pad to apply circular and vertical pressure on each acupoint, with the other four fingers stabilizing against the skin to ensure even pressure. The pressure is gradually increased from light to moderate until the patient experiences sensations of soreness, numbness, or swelling, commonly described as deqi (Ye Meiling et al., 2020). Each acupoint is pressed vertically for 3 seconds, then rotated clockwise at a rate of 2-3 rotations per second for another 3 second
Other Names:
|
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Active Comparator: Group 2
Holding a pressure ball Group 2reduces pain and anxiety pain.
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Interventions Group 1 - Acupoint Pressure Group 2 - Hand-Held Pressure Ball Control Group 3 - Conventional Treatment Other Names: Stress ball holding, acupoint pressure, conventional treatment Description: Before the intervention, subjects completed a pre-test. Afterward, they assumed a relaxed, comfortable lying position. The examiner applied acupoint pressure at four specific points: Hegu (LI4), Shenmen (HT7), Neiguan (PC6), and Zhongchong (PC9). The technique involves using the thumb pad to apply circular and vertical pressure on each acupoint, with the other four fingers stabilizing against the skin to ensure even pressure. The pressure is gradually increased from light to moderate until the patient experiences sensations of soreness, numbness, or swelling, commonly described as deqi (Ye Meiling et al., 2020). Each acupoint is pressed vertically for 3 seconds, then rotated clockwise at a rate of 2-3 rotations per second for another 3 second
Other Names:
|
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Sham Comparator: Group 3
conventional group 3 treatmente.
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Interventions Group 1 - Acupoint Pressure Group 2 - Hand-Held Pressure Ball Control Group 3 - Conventional Treatment Other Names: Stress ball holding, acupoint pressure, conventional treatment Description: Before the intervention, subjects completed a pre-test. Afterward, they assumed a relaxed, comfortable lying position. The examiner applied acupoint pressure at four specific points: Hegu (LI4), Shenmen (HT7), Neiguan (PC6), and Zhongchong (PC9). The technique involves using the thumb pad to apply circular and vertical pressure on each acupoint, with the other four fingers stabilizing against the skin to ensure even pressure. The pressure is gradually increased from light to moderate until the patient experiences sensations of soreness, numbness, or swelling, commonly described as deqi (Ye Meiling et al., 2020). Each acupoint is pressed vertically for 3 seconds, then rotated clockwise at a rate of 2-3 rotations per second for another 3 second
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
Time Frame: This study used Visual Analogue Scales (VAS) to measure patient pain. Divide a straight line about 10 centimeters into 10 equal parts from left to right. The left side is 0 points, no pain at all, and the right side is 10 points, very painful. Ask the su
|
Acupressure relieves pain and relieves anxiety
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This study used Visual Analogue Scales (VAS) to measure patient pain. Divide a straight line about 10 centimeters into 10 equal parts from left to right. The left side is 0 points, no pain at all, and the right side is 10 points, very painful. Ask the su
|
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The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
Time Frame: Heart rate variability (HRV, Heart Rate Variability) in patients undergoing local anesthesia surgery refers to the change in heartbeat intervals. High HRV is generally considered a sign of health, meaning that the heart is able to flexibly respond to var
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Acupressure with HRV
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Heart rate variability (HRV, Heart Rate Variability) in patients undergoing local anesthesia surgery refers to the change in heartbeat intervals. High HRV is generally considered a sign of health, meaning that the heart is able to flexibly respond to var
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The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
Time Frame: This study used the Chinese version of The State-Trait Anxiety Inventory (STAI-6) to measure the patient's anxiety state. The Short State-Trait Anxiety Inventory-6 (Short State-Trait Anxiety Inventory-6) consists of 6 questions selected from the STAI on
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Physiological effects
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This study used the Chinese version of The State-Trait Anxiety Inventory (STAI-6) to measure the patient's anxiety state. The Short State-Trait Anxiety Inventory-6 (Short State-Trait Anxiety Inventory-6) consists of 6 questions selected from the STAI on
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Collaborators and Investigators
Sponsor
Publications and helpful links
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Local Anesthesia
- MMH IRB (Other Identifier: MMH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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