This is a study protocol for a single-center, randomized controlled study conducted at the Affiliated Hospital of Jiaxing University. The planned population includes 252 female patients scheduled for elective surgery under general anesthesia. The intervention is active repetitive transcranial magnetic stimulation (rTMS) compared to sham rTMS.
The primary outcome is the change in anxiety score from baseline to 3 days post-operation. Secondary outcomes include anxiety scores, occurrence of postoperative delirium (POD), pain scores, frailty scores, and sleep quality scores. Follow-up is limited to 3 days post-operation.
Safety data such as adverse events, serious adverse events, discontinuations, and tolerability are not reported in this protocol. Limitations are not yet available as this is a protocol. Funding and conflicts of interest are not reported.
The practice relevance is expected to offer a successful non-pharmacological treatment approach for clinical practice, but this is speculative until results are available. Clinicians should await the completed study before considering rTMS for perioperative anxiety.
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IntroductionPerioperative anxiety is a widespread psychological issue among patients undergoing surgery and often has a significant impact on patient outcomes. Due to physiological and psychological characteristics such as hormonal fluctuations and higher emotional sensitivity, female patients generally have a higher incidence of perioperative anxiety compared to male patients. This investigation aims to examine the repetitive transcranial magnetic stimulation (rTMS) effects on perioperative anxiety in female patients.MethodsThis single-center, randomized, regulated investigation will be performed at the Affiliated Hospital of Jiaxing University. The investigation plans to enroll 252 female individuals scheduled for elective surgery under general anesthesia, who will be classified in a random manner to active rTMS or sham rTMS. The primary outcome is the change in anxiety score from baseline to 3 days post-operation. Secondary outcome measures include anxiety scores, occurrence of postoperative delirium (POD), pain scores, frailty scores, and sleep quality scores. Intention-to-treat and per-protocol populations were employed to conduct analyses.DiscussionThis research aims to estimate the influence of rTMS on perioperative anxiety in female patients. It is expected to offer a successful non-pharmacological treatment approach for clinical practice, alleviate anxiety symptoms in female patients during the perioperative period, and enhance the safety of surgical procedure and the quality of post-operative recovery for patients.Clinical trial registrationhttps://www.chictr.org.cn/index.html, identifier ChiCTR2500097991.