Effect of Electronic Moxibustion Apparatus on Pain Degree and Wound Healing of Patients After Craniocerebral Surgery
NCT Number: NCT06534710
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patients Undergoing Craniocerebral Surgery
Interventions: DEVICE: electronic moxibustion apparatus
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 228
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2025-08-01

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.

Primary Outcome Measures: pain score, Awake patients were scored with numeric rating scales (NRS). 0 was classified as no pain, 1-3 was classified as mild pain (pain did not affect sleep), 4-6 was classified as moderate pain (pain did not affect sleep), and 7-10 was classified as severe pain (unable to fall asleep or wake up with pain). Patients with coma or disturbance of consciousness were treated with behavioral pain scale (specific score)., Baseline and 5 days after intervention
Secondary Outcome Measures: Incision healing score, Scalp incision healing criteria were evaluated, with a score of 3 to 13,3 to 5 as incision healing, and ≥6 as poor incision healing. The surgical incisions were evaluated and recorded by nurses daily according to the wound healing scale., Baseline and 5 days after intervention|Incision healing time, According to the scalp incision healing standard, when the score is less than 6 points, it is considered as surgical incision healing. If the surgical incision had not healed at the time of discharge, the wound healing score at discharge was recorded., 4 weeks after intervention|The occurrence of adverse events in incision healing, Adverse reactions related to surgical incision healing (such as suppuration, crusts, tension blisters, skin ecchymosis around the incision or incision split, etc.), severity and treatment methods were included in the study during the study process, and their safety was objectively evaluated., Baseline and 5 days after intervention