Abdominal SurgeriesNCT06978335
Acupoint Stimulation Improves Postoperative Wound Pain
A study testing Acupoint Stimulation in people with Abdominal Surgeries and Pain, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
Postoperative pain remains one of the most common and distressing symptoms experienced by surgical patients. Poorly managed postoperative pain can impede recovery, reduce patient willingness to mobilize, increase the risk of complications, and negatively affect overall quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgeries, Pain, Acupuncture Points
- What is being tested?
- Acupoint Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jun 2024to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Surgical wound length ≥ 10 cm
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Receiving intravenous patient-controlled analgesia (IV PCA)
- Clear consciousness and ability to communicate
- Willingness to participate and provide informed consent
Who cannot join
- Presence of arrhythmia
- Implanted artificial cardiac pacemaker
- Cutaneous lesions at the acupoint or auricular application sites
- History of chronic pain or abdominal surgery within the past 6 months
- Non-ambulatory status prior to surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acupoint Stimulation Intervention Improves Postoperative Wound Pain and Mobility in Patients With Abdominal Surgery
Postoperative pain remains one of the most common and distressing symptoms experienced by surgical patients. Poorly managed postoperative pain can impede recovery, reduce patient willingness to mobilize, increase the risk of complications, and negatively affect overall quality of life. Currently, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are the primary pharmacological strategies for managing postoperative pain. However, these medications often carry the risk of adverse effects and may not adequately address all aspects of patient comfort and recovery.
In response to this challenge, this study aims to evaluate the effects of a non-pharmacological, non-invasive intervention-acupoint stimulation-on postoperative wound pain and mobilization in patients undergoing abdominal surgery. Ultimately, this study seeks to contribute to the development of more diversified and patient-centered pain management strategies, with the expectation that the integration of Chinese and Western medicine will lead to improved patient care and enhanced postoperative recovery.
- Conditions
- Abdominal Surgeries, Pain, Acupuncture Points
- Being tested
- Acupoint Stimulation, Sham Acupoint Stimulation
- Keywords
- acupoint stimulation, postoperative pain
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupoint StimulationOther
This intervention involves acupoint stimulation and auricular acupressure. Stimulation of selected body acupoints is administered by trained personnel following a standardized protocol. The intervention is provided once daily for three consecutive days, beginning post-surgery. For auricular acupressure, additional auricular points are chosen based on the involved abdominal organ and its corresponding viscera-meridian locations on the auricle. Vaccaria seeds are applied to the selected points with adhesive patches, and patients are instructed to apply pressure to the points regularly throughout the day.
Sham Acupoint StimulationOther
Participants in this group will receive a sham acupoint stimulation procedure. Acupoint stimulation will be using identical procedures to the experimental group, without applying pressure. No stimulation or manipulation was performed. The frequency and timing of the sham intervention matched that of the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Acupoint Stimulation | Experimental | Acupoint stimulation was administered on six points and auricular points on three points on the left ear, additional auricular points were selected according to the abdominal organ involved in surgery and its corresponding meridian representation on the auricle. Receives: Other: Acupoint Stimulation |
| Control: Sham Acupoint Stimulation | Sham comparator | Not described Receives: Other: Sham Acupoint Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS). The primary analysis will focus on changes in pain intensity over time between the two groups.
Measured: At 1, 4, 12, 24, 48, and 72 hours post-surgery
Secondary outcomes (1)
Pain Impact Assessed by Brief Pain Inventory - Taiwan Version (BPI-Taiwan)
The Brief Pain Inventory - Taiwan version (BPI-Taiwan) will be used to assess the impact of pain on various aspects of daily functioning. Total and subscale scores will be analyzed to evaluate differences in pain interference between the two groups.
Measured: On postoperative Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start19 Jun 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeriesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978335
- Sponsor's protocol ID
- (1090)113A-20
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupoint Stimulation Intervention Improves Postoperative Wound Pain and Mobility in Patients With Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06978335
- Acronym / sponsor ID
- (1090)113A-20
- Conditions
- Abdominal Surgeries, Pain, Acupuncture Points
- Keywords
- acupoint stimulation, postoperative pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 May 2025 (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.
Postoperative pain remains one of the most common and distressing symptoms experienced by surgical patients. Poorly managed postoperative pain can impede recovery, reduce patient willingness to mobilize, increase the risk of complications, and negatively affect overall quality of life. Currently, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are the primary pharmacological strategies for managing postoperative pain. However, these medications often carry the risk of adverse effects and may not adequately address all aspects of patient comfort and recovery.
In response to this challenge, this study aims to evaluate the effects of a non-pharmacological, non-invasive intervention-acupoint stimulation-on postoperative wound pain and mobilization in patients undergoing abdominal surgery. Ultimately, this study seeks to contribute to the development of more diversified and patient-centered pain management strategies, with the expectation that the integration of Chinese and Western medicine will lead to improved patient care and enhanced postoperative recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Acupoint Stimulation | Experimental | Other: Acupoint StimulationAcupoint stimulation was administered on six points and auricular points on three points on the left ear, additional auricular points were selected according to the abdominal organ involved in surgery and its corresponding meridian representation on the auricle. |
| Control: Sham Acupoint Stimulation | Sham comparator | Other: Sham Acupoint Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Surgical wound length ≥ 10 cm
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Receiving intravenous patient-controlled analgesia (IV PCA)
- Clear consciousness and ability to communicate
Key exclusion criteria (5 listed)
- Presence of arrhythmia
- Implanted artificial cardiac pacemaker
- Cutaneous lesions at the acupoint or auricular application sites
- History of chronic pain or abdominal surgery within the past 6 months
- Non-ambulatory status prior to surgery
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 |
|---|---|---|
| Acupoint StimulationThis intervention involves acupoint stimulation and auricular acupressure. Stimulation of selected body acupoints is administered by trained personnel following a standardized protocol. The intervention is provided once daily for three consecutive days, beginning post-surgery. For auricular acupressure, additional auricular points are chosen based on the involved abdominal organ and its corresponding viscera-meridian locations on the auricle. Vaccaria seeds are applied to the selected points with adhesive patches, and patients are instructed to apply pressure to the points regularly throughout the day. | Other | Experimental: Acupoint Stimulation |
| Sham Acupoint StimulationParticipants in this group will receive a sham acupoint stimulation procedure. Acupoint stimulation will be using identical procedures to the experimental group, without applying pressure. No stimulation or manipulation was performed. The frequency and timing of the sham intervention matched that of the experimental group. | Other | Control: Sham Acupoint Stimulation |
Primary outcome
Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: At 1, 4, 12, 24, 48, and 72 hours post-surgery
Pain intensity will be assessed using the Visual Analog Scale (VAS). The primary analysis will focus on changes in pain intensity over time between the two groups.
1 secondary outcome
Pain Impact Assessed by Brief Pain Inventory - Taiwan Version (BPI-Taiwan)
Time frame: On postoperative Day 3
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 28 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupoint Stimulation in people with Abdominal Surgeries and Pain, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. 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: enrolling by invitation, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: At 1, 4, 12, 24, 48, and 72 hours post-surgery). 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 28 May 2025.