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

NCT ID: NCT06534710

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-08-01

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.

Conditions

Patients Undergoing Craniocerebral Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

experimental group

On the basis of the control group, an electronic moxibustion instrument was used every day (CreditEase Medical Device Technology, YXB-AJY-06) : The patient was placed in a comfortable lying position and the surgical incision area was fully exposed. The nurse placed the moxibustion tablets on the moxibustion head of the electronic moxibustion instrument, and the moxibustion head was connected to the electronic moxibustion treatment instrument through a wire. The moxibustion temperature should be slightly red on the skin and the patient should tolerate it. The total intervention time was 5 days, and the relevant study data at discharge were recorded if the patient was discharged early

Group Type: EXPERIMENTAL

electronic moxibustion apparatus

Intervention Type: DEVICE

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

control group

The routine nursing plan was adopted. (1) Pain knowledge education, including understanding of pain and analgesic drugs, pain assessment methods, selection of analgesic drugs, etc. within 24 hours of admission and before and after surgery, to alleviate patients' fear and anxiety about pain; ② After surgery, choose the appropriate position, gently turn over, and try to avoid pain caused by the change of position and pressure on the affected side; ③ After the gauze or dressing was removed from the surgical incision, the nurse disinfected the surgical incision twice a day with iodophor cotton swabs, observed the healing of the wound at the surgical incision every day, and reported to the doctor in time if there was blood or fluid leakage.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

electronic moxibustion apparatus

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

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine，Zhejiang University

Yiwu, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

guanhua hou

Role: CONTACT

jigoulunli_zy4y@163.com

+86 0579-89935052

Facility Contacts

guanhua hou

Role: primary

Other Identifiers

KY-2024-117

Identifier Type: -

Identifier Source: org_study_id