The Effects of Acupressure on Pain, Swelling and Comfort in Patients With Femoral Fracture Surgery

Not Applicable

Active, not recruiting

• Conditions: Acupressure

• Registration Number: NCT06914323
• Lead Sponsor: Hungkuang University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-18
• Study First Submitted: 2025-03-11
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-02-18
• Study Completion: 2026-02-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. 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.
2. Adults aged 18 years or older.
3. Conscious and able to communicate in Mandarin or Taiwanese (Min Nan).
4. Intact and without missing lower limbs.
5. Willing to sign the informed consent form after being briefed on the study objectives and procedures.

Exclusion Criteria

1. Diagnosis of musculoskeletal tumors.
2. History of cerebrovascular accident or peripheral vascular neuropathy.
3. Major medical conditions such as cirrhosis, renal failure, heart failure, cancer, and severe brain diseases.
4. Edema caused by nutritional deficiency or mucinous causes.
5. Pregnant or lactating women.
6. Patients using patient-controlled analgesia post-surgery.
7. Severe psychiatric disorders or perceptual disorders.
8. Platelet count less than 20 x 10^3/uL before screening.
9. Albumin less than 3.5g/dL before screening.
10. Individuals closely related to the trial personnel, such as immediate family or dependents of the principal investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in pain	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	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	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.

Trial Locations

Locations (1)

Hungkuang University; 🇨🇳 Taichung, Taiwan