Clinical trial NCT06681519: The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
Official title: The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Assessing the Effect of Acupoint Massage on Pain and Anxiety in Patients Undergoing Surgery Under Local Anesthesia
Keywords: Key words: local anaesthesia , acupressure, physiology, psychology, autonomic nerve system
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
timeFrame: 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
measure: The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
timeFrame: 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
measure: The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: Yu Jui Feng
city: Taipei, Taiwan
country: Taiwan
facility: YuJui Feng
Study officials:
References: