Effect of Electronic Moxibustion Apparatus on Pain Degree and Wound Healing of Patients After Craniocerebral Surgery

Официальное название

Ffect of Electronic Moxibustion Apparatus on Pain Degree and Wound Healing of Patients After Craniocerebral Surgery

Обзор

According to statistics, about 70% to 84% of patients after craniocerebral surgery will have moderate to severe wound pain, especially within 24h after surgery \[1\]. Pain can reduce the comfort of patients, affect the speed of incision healing, and interfere with the prognosis and rehabilitation effect in the later stage. At present, non-steroidal drugs are often used clinically for analgesic intervention, but the use of drugs often brings gastrointestinal discomfort such as nausea and vomiting, and is easy to produce dependence. In addition, redness, swelling, fluid leakage, cracking or no hair growth around the incision are prone to poor surgical incision healing after cranial surgery \[2\]. Poor healing of surgical incision will not only lead to prolonged hospital stay, increase hospital costs, but also bring trauma and pain to patients, and even induce medical disputes. Moxibustion is an important branch of TCM physiotherapy. It has the functions of warming, clearing and dispersing. It can inhibit inflammation through various ways, relieve local pain and edema, and its effect is mild. At present, moxibustion is mostly used to promote the recovery of urinary or gastrointestinal functions, and the healing of surgical wounds after anal fistula or perianal abscess. There are no relevant studies on its application to surgical incision in patients after craniocerebral surgery. The effect of moxibustion on improving the pain and healing of surgical incision in patients after craniocerebral surgery is still unknown. Considering the disadvantages of traditional moxibustion, such as inconvenient operation, easy burn at high temperature and environmental pollution by moxibustion smoke, this study will use an electronic moxibustion instrument. Patients on the third day after craniectomy were divided into two groups by random number table method. Patients in the control group were given routine care; patients in the experimental group were irradiated with the postoperative incision with an electronic moxibustion instrument every day on the basis of the control group. The pain score at the surgical incision, the healing score value of the surgical incision, the healing time of the incision and the occurrence of adverse events during the incision healing were compared between the two groups.

Вмешательства

• Устройство electronic moxibustion apparatus
  The experimental group used the electronic moxibustion instrument every day on the basis of the control group

Первичные конечные точки

• pain score [Срок оценки: Baseline and 5 days after intervention]

Вторичные конечные точки (3)

• Incision healing score [Срок оценки: Baseline and 5 days after intervention]
• Incision healing time [Срок оценки: 4 weeks after intervention]
• The occurrence of adverse events in incision healing [Срок оценки: Baseline and 5 days after intervention]

Критерии участия

Критерии включения

• Patients on the third day after craniocerebral surgery; ② Patients with vital signs and stable condition for more than 24 hours; (3) Meet the requirements of medical research ethics, and the subjects voluntarily join the clinical study and sign the informed consent; (4) The expected duration of hospitalization is > 3 days; ⑤ Age > 18 years old;

Критерии исключения

① Patients with serious heart, lung, liver, kidney and other vital organ dysfunction; ② Female patients in lactation period, menstrual period, pregnancy period or allergic constitution; Exclusion criteria: ① Patients or their family members should be excluded from this study in time due to disputes with the hospital during diagnosis or treatment (including requests for early transfer and termination of treatment).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine — Yiwu

Идентификаторы

NCT: NCT06534710 · KY-2024-117

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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