Assessing the Effect of Acupoint Massage on Pain and Anxiety in Patients Undergoing Surgery Under Local AnesthesiaLANCT06681519
The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
A study of Assessing the Effect of Acupoint Massage on Pain and Anxiety in Patients Undergoing Surgery Under Local Anesthesia, run by Yu-Jui Feng at 2 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Assessing the Effect of Acupoint Massage on Pain and Anxiety in Patients Undergoing Surgery Under Local Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Sep 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
- 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.
- 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).
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Being tested
- Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatment
- Keywords
- Key words: local anaesthesia , acupressure, physiology, psychology, autonomic nerve system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional TreatmentProcedure or surgery
Also called 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
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Acupoint pressure Group 1relieves pain and anxiety pain . Receives: Procedure: Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatment |
| Group 2 | Active comparator | Holding a pressure ball Group 2reduces pain and anxiety pain. Receives: Procedure: Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatment |
| Group 3 | Sham comparator | conventional group 3 treatmente. Receives: Procedure: Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
Acupressure relieves pain and relieves anxiety
Measured: 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
Acupressure with HRV
Measured: 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
Physiological effects
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Sep 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessing the Effect of Acupoint Massage on Pain and Anxiety in Patients Undergoing Surgery Under Local AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Jui Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu-Jui Feng, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681519
- Sponsor's protocol ID
- Local Anesthesia
- Other IDs
- MMH IRB
- Acronym
- LA
- Status last verified
- Nov 2024
- First submitted
- 16 Sep 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
- ClinicalTrials.gov ID
- NCT06681519
- Acronym / sponsor ID
- LA / Local Anesthesia
- Keywords
- Key words: local anaesthesia , acupressure, physiology, psychology, autonomic nerve system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yu-Jui FengUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional TreatmentAcupoint pressure Group 1relieves pain and anxiety pain . |
| Group 2 | Active comparator | Procedure: Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional TreatmentHolding a pressure ball Group 2reduces pain and anxiety pain. |
| Group 3 | Sham comparator | Procedure: Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional Treatmentconventional group 3 treatmente. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Group 1 - Acupoint Pressure Experimental Group 2 - Pressure Ball Control Group - Conventional TreatmentAlso: 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 - ConventionInterventions 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 | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- https://pubmed.ncbi.nlm.nih.gov/?term=%231+AND+%235\&sort=date\&filter=pubt.randomizedcontrolledtrial\&filter=pubt.randomizedcontrolledtrialLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Assessing the Effect of Acupoint Massage on Pain and Anxiety in Patients Undergoing Surgery Under Local Anesthesia, run by Yu-Jui Feng at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.