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

NCT ID: NCT06681519

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Assessing the Effect of Acupoint Massage on Pain and Anxiety in Patients Undergoing Surgery Under Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Research model type: Indicate whether parallel group design, crossover design, causal comparison, etc. are used. For example: "This study uses a parallel group design, randomly assigning subjects to the experimental group and the control group."

Details of the intervention model: If different intervention approaches or multiple intervention groups are involved, you can describe the details of each intervention group. For example: "The experimental group received specific acupoint massage (Hegu LI4, Shenmen HT7), and the control group received standard care."

Allocation and randomization methods: Describe the allocation method, such as random assignment or stratified randomization.

Experimental controls: If there are control groups, placebo controls, or other controls, you can state this here.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Acupoint pressure Group 1relieves pain and anxiety pain .

Group Type ACTIVE_COMPARATOR

Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatment

Intervention Type PROCEDURE

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

Group 2

Holding a pressure ball Group 2reduces pain and anxiety pain.

Group Type ACTIVE_COMPARATOR

Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatment

Intervention Type PROCEDURE

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

Group 3

conventional group 3 treatmente.

Group Type SHAM_COMPARATOR

Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatment

Intervention Type PROCEDURE

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

Interventions

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Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatment

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

Intervention Type PROCEDURE

Other Intervention Names

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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

Eligibility Criteria

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Exclusion Criteria

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yu-Jui Feng

OTHER

Sponsor Role lead

Responsible Party

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Yu-Jui Feng

postgraduate

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Yu Jui Feng

Taipei, Taiwan, , Taiwan

Site Status

YuJui Feng

Taipei, Taiwan, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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https://pubmed.ncbi.nlm.nih.gov/?term=%231+AND+%235&sort=date&filter=pubt.randomizedcontrolledtrial&filter=pubt.randomizedcontrolledtrial

https://pubmed.ncbi.nlm.nih.gov/?term=%231+AND+%235\&sort=date\&filter=pubt.randomizedcontrolledtrial\&filter=pubt.randomizedcontrolledtrial

Other Identifiers

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MMH IRB

Identifier Type: OTHER

Identifier Source: secondary_id

Local Anesthesia

Identifier Type: -

Identifier Source: org_study_id

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