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NCT Number: NCT06914323

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hungkuang University

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Acupressure

Procedure

improvements in pain, limb swelling, and comfort

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hungkuang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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