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Effects of the Kampo medicine Yokukansan for perioperative anxiety and postoperative pain in women undergoing breast surgery: A randomized, controlled trial

ABSTRACT: Yokukansan (YKS) is a traditional Japanese herbal (Kampo) medicine prescribed for anxiety. In this randomized controlled trial, we compared the subjective assessment of anxiety using questionnaires and its objective assessment using salivary alpha-amylase concentrations in YKS and control (CNT) groups of women undergoing breast surgery. The trial was registered at the University Hospital Medical Information Network Clinical Trials Registry (registration number: UMIN000028998), and the investigators were blinded to drug administration. One hundred patients who underwent breast cancer surgery were allocated to either the YKS or the CNT group. Finally, 35 and 42 patients in the YKS and CNT groups were analyzed, respectively. The YKS group received two 2.5 g doses of the medication before sleeping on the night before surgery and 2 h before inducing anesthesia, while the CNT group did not receive medication preoperatively. Patients answered two questionnaires, the Hospital Anxiety and Depression Scale and the State-Trait Anxiety Inventory, pre-and postoperatively as subjective anxiety assessments. As an objective anxiety indicator, salivary alpha-amylase levels were measured the day before, directly before, and the day after surgery (T3). In the YKS group, salivary alpha-amylase scores directly before operation were significantly lower than those on the day before surgery and at one day postoperatively (F [2,150] = 3.76, p = 0.03). Moreover, the Hospital Anxiety and Depression Scale-Anxiety and State-Trait Anxiety Inventory-Trait scores were significantly more improved postoperatively in the YKS group than in the CNT group (difference in Hospital Anxiety and Depression Scale-Anxiety: YKS, mean -2.77, 95% confidence interval [-1.48 –-4.06], p <0.001, and CNT, -1.43 [-0.25–-2.61], p = 0.011; and difference in State-Trait Anxiety Inventory: YKS group, -4.23 [-6.95–-1.51], p = 0.0004; and CNT group, 0.12 [-2.36–2.60], p = 0.92). No side effects were associated with YKS. YKS may reduce perioperative anxiety in patients undergoing surface surgery.

SUBMITTER: Tanaka M

PROVIDER: S-EPMC8612547 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAnxiety may adversely impact mother and her newborn. Music listening is a safe and efficacious treatment that may to reduce perioperative anxiety. The effect on acute pain and pain catastrophizing scores remains unclear. We aimed to determine whether perioperative music listening reduces anxiety, acute pain, and pain catastrophizing scale (PCS) scores following elective cesarean delivery under spinal anesthesia.MethodsAfter randomization into music listening and control groups, baseline patient characteristics, visual analog scale-anxiety (VAS-A) scores, pain scores, PCS total and sub-scores, and music preferences were collected preoperatively. Before surgery, parturients in the experimental group listened to music of their own choice for 30 min. Music listening was continued during administration of spinal anesthesia and cesarean delivery, and for 30 min following surgery. Postoperative VAS-A score, acute pain score, PCS scores, music preferences, satisfaction score, and feedback were recorded.ResultsWe analyzed 108 parturients (music: n = 53; control: n = 55). Music listening was associated with reduced postoperative VAS-A (mean difference (MD) -1.43, 95%CI -0.63 to -2.22), PCS total score (MD -6.39, 95%CI -2.11 to -10.66), PCS sub-scores on rumination (MD -1.68, 95%CI -0.12 to -3.25), magnification (MD -1.53, 95%CI -0.45 to -2.62), and helplessness (MD -3.17, 95%CI -1.29 to -5.06) sub-scores. There was no significant difference in postoperative acute pain scores. The majority (> 95%) of parturients reported "excellent" and "good" satisfaction with music listening, and most provided positive feedback.ConclusionPerioperative music listening was associated with reduced postoperative anxiety and lower pain catastrophizing. Based on the good patient satisfaction and positive feedback received, the use of music listening in the obstetric setting is recommended.Trial registrationThis study was registered on Clinicaltrials.gov NCT03415620 on 30/01/2018.

Project description:ImportanceBoth augmented reality (AR) and virtual reality (VR) have had increasing applications in medicine, including medical training, psychology, physical medicine, rehabilitation, and surgical specialties, such as neurosurgery and orthopedic surgery. There are little data on AR's effect on patients' anxiety and experiences.ObjectiveTo determine whether the use of an AR walkthrough effects patient perioperative anxiety.Design, setting, and participantsThis randomized clinical trial was conducted at an outpatient surgery center in 2021 to 2022. All patients undergoing elective orthopedic surgery with the senior author were randomized to the treatment or control group. Analyses were conducted per protocol. Data analysis was performed in November 2022.InterventionAR experience explaining to patients what to expect on their day of surgery and walking them through the surgery space. The control group received the standard educational packet.Main outcomes and measuresThe main outcome was change in State-Trait Anxiety Inventory (STAI) from the screening survey to the preoperative survey.ResultsA total of 140 patients were eligible, and 45 patients either declined or were excluded. Therefore, 95 patients (63 [66.3%] male; mean [SD] age, 38 [16] years) were recruited for the study and included in the final analysis; 46 patients received the AR intervention, and 49 patients received standard instructions. The AR group experienced a decrease in anxiety from the screening to preoperative survey (mean score change, -2.4 [95% CI, -4.6 to -0.3]), while the standard care group experienced an increase (mean score change, 2.6 [95% CI, 0.2 to 4.9]; P = .01). All patients postoperatively experienced a mean decrease in anxiety score compared with both the screening survey (mean change: AR, -5.4 [95% CI, -7.9 to -2.9]; standard care, -6.9 [95% CI, -11.5 to -2.2]; P = .32) and preoperative survey (mean change: AR, -8.0 [95% CI, -10.3 to -5.7]; standard care, -4.2 [95% CI, -8.6 to 0.2]; P = .19). Of 42 patients in the AR group who completed the postoperative follow-up survey, 30 (71.4%) agreed or strongly agreed that they enjoyed the experience, 29 (69.0%) agreed or strongly agreed that they would recommend the experience, and 28 (66.7%) agreed or strongly agreed that they would use the experience again. No differences were observed in postoperative pain levels or narcotic use.Conclusions and relevanceIn this randomized clinical trial, the use of AR decreased preoperative anxiety compared with traditional perioperative education and handouts, but there was no significant effect on postoperative anxiety, pain levels, or narcotic use. These findings suggest that AR may serve as an effective means of decreasing preoperative patient anxiety.Trial registrationClinicalTrials.gov Identifier: NCT04727697.

Project description:BackgroundPreoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; therefore, these conditions require early prevention and treatment. However, no standard preventive or therapeutic methods have been established for them. Yokukansan, a Japanese herbal medicine for the treatment of insomnia and anxiety, causes relatively few adverse drug reactions and effectively improves the behavioral and psychological symptoms of dementia. Thus, it is expected to be useful for treating and/or preventing perioperative psychiatric symptoms in patients with cancer. The objective of this study is to clarify the therapeutic effect of Yokukansan for preoperative anxiety and its preventive effect on postoperative delirium in cancer patients, as well as to confirm its safety profile.MethodsThis study is a randomized, double-blind, placebo-controlled study in cancer patients scheduled to undergo tumor resection. Patients who provide consent are randomly allocated to receive oral administration of Yokukansan or placebo, and study drug administration is continued for 4 days or longer prior to surgery. We defined two primary endpoints, change in preoperative anxiety and incidence of postoperative delirium. Secondary endpoints are severity score of postoperative delirium, duration of postoperative delirium, amount of benzodiazepines used prior to surgery, amount of antipsychotic agents used after surgery, and number of postoperative hospitalization days. We plan to complete the analysis on March 31, 2021. The target number of registered patients is 110 per group, or 220 in total.DiscussionThis study is the first randomized, double-blind, placebo-controlled study intended to clarify the effects of a Japanese herbal medicine, Yokukansan, in the prevention and treatment of perioperative psychiatric symptoms in patients with cancer. The trial was initiated on August 14, 2017, with 195 subjects randomized by October 5, 2018.Trial registrationUMIN Clinical Trials Registry (UMIN-CTR), UMIN000027561 . Registered on 31 May 2017.

Project description:IntroductionIntravenous lignocaine is an amide local anaesthetic known for its analgesic, antihyperalgesic and anti-inflammatory properties. Administration of intravenous lignocaine has been shown to enhance perioperative recovery parameters. This is the protocol for a systematic review which intends to summarise the evidence base for perioperative intravenous lignocaine administration in patients undergoing spinal surgery.Methods and analysisOur primary outcomes include: postoperative pain scores at rest and movement at predefined early, intermediate and late time points and adverse events. Other outcomes of interest include perioperative opioid consumption, composite morbidity, surgical complications and hospital length of stay. We will include randomised controlled trials, which compared intravenous lignocaine infusion vs standard treatment for perioperative analgesia. We will search electronic databases from inception to present; MEDLINE, EMBASE and Cochrane Library (Cochrane Database of Systematic Reviews and CENTRAL). Two team members will independently screen all citations, full-text articles and abstract data. The individual study risk of bias will be appraised using the Cochrane risk of bias tool. We will obtain a risk ratio or mean difference (MD) from the intervention and control group event rates based on the nature of data. We will correct for the variable measurement tools by using the standardised MD (SMD). We will use a random-effects model to synthesise data. We will conduct five subgroup analysis: major versus minor surgery, emergency versus elective surgery, patients with chronic pain conditions versus patients without, duration of lignocaine infusion and adult versus paediatric. Confidence in cumulative evidence for will be classified according to the Grading of Recommendations, Assessment, Development and Evaluation system. We will construct summary of findings tables supported detailed evidence profile tables for predefined outcomes.Ethics and disseminationFormal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication.Prospero registration numberCRD420201963314.

Project description:BackgroundThe international scale and spread of evidence-based perioperative medicine for older people undergoing surgery (POPS) services has not yet been fully realised. Implementation science provides a structured approach to understanding factors that act as barriers and facilitators to the implementation of POPS services. In this study, we aimed to identify factors that influence the implementation of POPS services in the UK.MethodsA qualitative case study at three UK health services was undertaken. The health services differed across contextual factors (population, workforce, size) and stages of POPS service implementation maturity. Semi-structured interviews with purposively sampled clinicians (perioperative medical, nursing, allied health, and pharmacy) and managers (n = 56) were conducted. Data were inductively coded, then thematically analysed using the Consolidated Framework for Implementation Research (CFIR).ResultsFourteen factors across all five CFIR domains were relevant to the implementation of POPS services. Key shared facilitators included stakeholders understanding the rationale of the POPS service, with support from their networks, POPS champions, and POPS clinical leads. We found substantial variation and flexibility in the way that health services responded to these shared facilitators and this was relevant to the implementation of POPS services.ConclusionsHealth services planning to implement a POPS service should use health service-specific strategies to respond flexibly to local factors that are acting as barriers or facilitators to implementation. To support implementation of a POPS service, we recommend health services prioritise understanding local networks, identifying POPS champions, and ensuring that stakeholders understand the rationale for the POPS service. Our study also provides a structure for future research to understand the factors associated with 'unsuccessful' implementation of a POPS service, which can inform ongoing efforts to implement evidence-based perioperative models of care for older people.

Project description:Background: Previous studies have suggested that dexmedetomidine may have a protective effect on renal function. However, it is currently unclear whether perioperative dexmedetomidine administration is associated with postoperative acute kidney injury (AKI) incidence risk in hypertensive patients undergoing non-cardiac surgery. Methods: This investigation was a retrospective cohort study. Hypertensive patients undergoing non-cardiac surgery in Third Xiangya Hospital of Central South University from June 2018 to December 2019 were included. The relevant data were extracted through electronic cases. The univariable analysis identified demographic, preoperative laboratory, and intraoperative factors associated with acute kidney injury. Multivariable stepwise logistic regression was used to assess the association between perioperative dexmedetomidine administration and postoperative acute kidney injury after adjusting for interference factors. In addition, we further performed sensitivity analyses in four subgroups to further validate the robustness of the results. Results: A total of 5769 patients were included in this study, with a 7.66% incidence of postoperative acute kidney injury. The incidence of postoperative acute kidney injury was lower in the dexmedetomidine-administered group than in the control group (4.12% vs. 8.06%, p < 0.001). In the multivariable stepwise logistic regression analysis, perioperative dexmedetomidine administration significantly reduced the risk of postoperative acute kidney injury after adjusting for interference factors [odds ratio (OR) = 0.56, 95% confidence interval (CI): 0.36-0.87, p = 0.010]. In addition, sensitivity analysis in four subgroups indicated parallel findings: i) eGRF <90 mL/min·1.73/m2 subgroup (OR = 0.40, 95% CI: 0.19-0.84, p = 0.016), ii) intraoperative blood loss <1000 mL subgroup (OR = 0.58, 95% CI: 0.36-0.94, p = 0.025), iii) non-diabetes subgroup (OR = 0.51, 95% CI: 0.29-0.89, p = 0.018), and iv) older subgroup (OR = 0.55, 95% CI: 0.32-0.93, p = 0.027). Conclusion: In conclusion, our study suggests that perioperative dexmedetomidine administration is associated with lower risk and less severity of postoperative acute kidney injury in hypertensive individuals undergoing non-cardiac surgery. Therefore, future large-scale RCT studies are necessary to validate this benefit.

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Effects of the Kampo medicine Yokukansan for perioperative anxiety and postoperative pain in women undergoing breast surgery: A randomized, controlled trial

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