The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia (LA)

November 7, 2024 updated by: Yu-Jui Feng

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

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

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan, Taiwan, 111
        • Yu Jui Feng
      • Taipei, Taiwan, Taiwan, 111
        • YuJui Feng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

1. The acceptance conditions of the subject must meet:

  1. Adults (20-64 years old).
  2. Mainly patients receiving local anesthesia.
  3. Those who have no abnormal limb sensation and good skin integrity, and can perform normal acupoint pressure.
  4. Those who are willing to participate in this study and can communicate in Mandarin and Taiwanese.

2. Exclusion conditions:

  1. Those who have taken painkillers before surgery.
  2. The surgical site is already inflamed.
  3. Those diagnosed with mental illness and cognitive impairment.
  4. Heart disease and arrhythmia (pacemaker).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Group 1
Acupoint pressure Group 1relieves pain and anxiety pain .

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:
  • Experimental Group 1 - Acupoint Pressure: Other Names: 「穴位按壓」、「Acupressure」 Experimental Group 2 - Pressure Ball: Other Names: 「Holding stress ball in hand」、「握壓力球」、「壓力球療法」 Control Group - Convention
Active Comparator: Group 2
Holding a pressure ball Group 2reduces pain and anxiety pain.

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:
  • Experimental Group 1 - Acupoint Pressure: Other Names: 「穴位按壓」、「Acupressure」 Experimental Group 2 - Pressure Ball: Other Names: 「Holding stress ball in hand」、「握壓力球」、「壓力球療法」 Control Group - Convention
Sham Comparator: Group 3
conventional group 3 treatmente.

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:
  • Experimental Group 1 - Acupoint Pressure: Other Names: 「穴位按壓」、「Acupressure」 Experimental Group 2 - Pressure Ball: Other Names: 「Holding stress ball in hand」、「握壓力球」、「壓力球療法」 Control Group - Convention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
Acupressure with HRV
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
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
Physiological effects
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Estimated)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

November 1, 2024

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)?

NO

IPD Plan Description

This study needs to be reviewed by the hospital's clinical ethics committee before it can be accepted. The written informed consent form is signed and dated, and the researcher's contact information is clearly stated on the consent form. Participants can terminate participation in the study at any time. After all participants agree and sign a written consent form, they will fulfill their confidentiality responsibilities. Subject information will be replaced with personal information by codes to protect subject privacy. The case data are collected, each case is individually coded and locked in a designated cabinet. The key holder of the cabinet is the researcher. After the research data are kept for two years, they are shredded with a fine shredder and discarded.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Clinical Trials on Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatment

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