AcupressureNCT06914323
The Effects of Acupressure on Pain, Swelling and Comfort in Patients With Femoral Fracture Surgery
A study testing Acupressure in people with Acupressure, run by Hungkuang University at 1 site in Taiwan.
Trial summary
Pain is a subjective and unpleasant sensory and emotional experience associated with actual or potential tissue damage. Fractures result from a disruption in the continuity of bone, where bones are subjected to traction, twisting, or compression, causing damage to the surrounding muscular tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acupressure
- What is being tested?
- Acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Feb 2025to 18 Feb 2026
- 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
- The patient was hospitalized due to injuries from an accident, diagnosed with unilateral femoral fracture and underwent open reduction internal fixation surgery, hemiarthroplasty, and total hip arthroplasty.
- Adults aged 18 years or older.
- Conscious and able to communicate in Mandarin or Taiwanese (Min Nan).
- Intact and without missing lower limbs.
- Willing to sign the informed consent form after being briefed on the study objectives and procedures.
Who cannot join
- Diagnosis of musculoskeletal tumors.
- History of cerebrovascular accident or peripheral vascular neuropathy.
- Major medical conditions such as cirrhosis, renal failure, heart failure, cancer, and severe brain diseases.
- Edema caused by nutritional deficiency or mucinous causes.
- Pregnant or lactating women.
- Patients using patient-controlled analgesia post-surgery.
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- Severe psychiatric disorders or perceptual disorders.
- Platelet count less than 20 x 10^3/uL before screening.
- Albumin less than 3.5g/dL before screening.
- Individuals closely related to the trial personnel, such as immediate family or dependents of the principal investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Pain is a subjective and unpleasant sensory and emotional experience associated with actual or potential tissue damage. Fractures result from a disruption in the continuity of bone, where bones are subjected to traction, twisting, or compression, causing damage to the surrounding muscular tissues. The treatment of displaced or complex fractures typically requires internal fixation surgery. 89% of fracture patients experience postoperative pain and swelling by the second day following open reduction and internal fixation surgery. These negative sensations can lead to increased pain, limb deformity, and neurovascular compression injuries. If postoperative pain is not adequately managed, it can affect wound healing, increase metabolism and oxygen consumption, and place additional strain on cardiopulmonary function. It is necessary to integrate alternative, non-pharmacological, non-invasive pain relief measures. Effectively and safely alleviating acute postoperative pain can enhance comfort, promote early mobilization, improve adherence to postoperative physical therapy, enhance quality of life and shorten hospital stays.
- Conditions
- Acupressure
- Being tested
- Acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureProcedure or surgery
improvements in pain, limb swelling, and comfort
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | Not described Receives: Procedure: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain
Pain is measured using the Visual Analog Scale (VAS). The left end is labeled as "no pain," which represents 0, and the right end as "the most severe pain imaginable," which represents 100.
Measured: post op day 1 to post op day 2
Change in limb swelling
Foot circumference at the midpoint of the line connecting the fifth toe to the lateral malleola is measured in centimeters for swelling assessment. A measuring tape is used. During the measurement, the patient is positioned in a supine posture.
Measured: post op day 1 to post op day 2
Changes in patient comfort
Shortened General Comfort Questionnaire (SGCQ) for measuring comfort. The questionnaire consists of 28 items, assessed on a 6-point Likert scale ranging from "strongly disagree" to "strongly agree." A score of 1 represents "strongly disagree," while a score of 6 represents "strongly agree." The total score ranges from 28 to 148, with higher scores indicating greater levels of comfort.
Measured: post op day 1 to post op day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start18 Feb 2025
- Primary completion18 Feb 2026 (estimated)
- Study completion18 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupressureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hungkuang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Tzu Chang, Hungkuang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914323
- Sponsor's protocol ID
- Interventional
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acupressure on Pain, Swelling and Comfort in Patients With Femoral Fracture Surgery
- ClinicalTrials.gov ID
- NCT06914323
- Acronym / sponsor ID
- Interventional
- Conditions
- Acupressure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hungkuang UniversityUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 18 Feb 2026 (estimated)
- Study completion
- 18 Feb 2026 (estimated)
- First posted
- 6 Apr 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.
Pain is a subjective and unpleasant sensory and emotional experience associated with actual or potential tissue damage. Fractures result from a disruption in the continuity of bone, where bones are subjected to traction, twisting, or compression, causing damage to the surrounding muscular tissues. The treatment of displaced or complex fractures typically requires internal fixation surgery. 89% of fracture patients experience postoperative pain and swelling by the second day following open reduction and internal fixation surgery. These negative sensations can lead to increased pain, limb deformity, and neurovascular compression injuries. If postoperative pain is not adequately managed, it can affect wound healing, increase metabolism and oxygen consumption, and place additional strain on cardiopulmonary function. It is necessary to integrate alternative, non-pharmacological, non-invasive pain relief measures. Effectively and safely alleviating acute postoperative pain can enhance comfort, promote early mobilization, improve adherence to postoperative physical therapy, enhance quality of life and shorten hospital stays.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Procedure: Acupressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient was hospitalized due to injuries from an accident, diagnosed with unilateral femoral fracture and underwent open reduction internal fixation surgery, hemiarthroplasty, and total hip arthroplasty.
- Adults aged 18 years or older.
- Conscious and able to communicate in Mandarin or Taiwanese (Min Nan).
- Intact and without missing lower limbs.
- Willing to sign the informed consent form after being briefed on the study objectives and procedures.
Key exclusion criteria (10 listed)
- Diagnosis of musculoskeletal tumors.
- History of cerebrovascular accident or peripheral vascular neuropathy.
- Major medical conditions such as cirrhosis, renal failure, heart failure, cancer, and severe brain diseases.
- Edema caused by nutritional deficiency or mucinous causes.
- Pregnant or lactating women.
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 |
|---|---|---|
| Acupressureimprovements in pain, limb swelling, and comfort | Procedure or surgery | Acupressure |
Primary outcome
Changes in pain
Time frame: post op day 1 to post op day 2
Pain is measured using the Visual Analog Scale (VAS). The left end is labeled as "no pain," which represents 0, and the right end as "the most severe pain imaginable," which represents 100.
Change in limb swelling
Time frame: post op day 1 to post op day 2
Foot circumference at the midpoint of the line connecting the fifth toe to the lateral malleola is measured in centimeters for swelling assessment. A measuring tape is used. During the measurement, the patient is positioned in a supine posture.
Changes in patient comfort
Time frame: post op day 1 to post op day 2
Shortened General Comfort Questionnaire (SGCQ) for measuring comfort. The questionnaire consists of 28 items, assessed on a 6-point Likert scale ranging from "strongly disagree" to "strongly agree." A score of 1 represents "strongly disagree," while a score of 6 represents "strongly agree." The total score ranges from 28 to 148, with higher scores indicating greater levels of comfort.
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 6 Apr 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. This study is not recruiting at the moment.
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 Acupressure in people with Acupressure, run by Hungkuang University 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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 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. 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?
Changes in pain (time frame: post op day 1 to post op day 2). 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 6 Apr 2025.