Clinical trial NCT06534710: Effect of Electronic Moxibustion Apparatus on Pain Degree and Wound Healing of Patients After Craniocerebral Surgery
Official title: Ffect of Electronic Moxibustion Apparatus on Pain Degree and Wound Healing of Patients After Craniocerebral Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patients Undergoing Craniocerebral Surgery
Keywords: Craniocerebral surgery
Electronic moxibustion
Wound healing;
Pain
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Creditease Medical Device Technology，YXB-AJY-06
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

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).

Primary outcomes:
measure: pain score
timeFrame: Baseline and 5 days after intervention
Secondary outcomes:
measure: Incision healing score
timeFrame: Baseline and 5 days after intervention
measure: Incision healing time
timeFrame: 4 weeks after intervention
measure: The occurrence of adverse events in incision healing
timeFrame: Baseline and 5 days after intervention
Other outcomes:
Locations:
city: Yiwu
country: China
facility: the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine，Zhejiang University
state: Zhejiang
Study officials:
References: