Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial.

BACKGROUND: Transcutaneous electric acupoint stimulation (TEAS) has shown benefits when used peri-operatively. However, the role of numbers of areas with acupoint stimulation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using TEAS in elderly patients subjected to gastrointestinal surgery, and comparing dual-acupoint and single-acupoint stimulation. METHODS/DESIGN: A multicenter, randomized, controlled, three-arm design, large-scale trial is currently undergoing in four hospitals in China. Three hundred and forty-five participants are randomly assigned to three groups in a 1:1:1 ratio, receiving dual-acupoint TEAS, single-acupoint TEAS, and no stimulation, respectively. The primary outcome is incidence of pulmonary complications at 30 days after surgery. The secondary outcomes include the incidence of pulmonary complications at 3 days after surgery; the all-cause mortality within 30 days and 1 year after surgery; admission to the intensive care unit (ICU) and length of ICU stay within 30 days after surgery; the length of postoperative hospital stay; and medical costs during hospitalization after surgery. DISCUSSION: The result of this trial (which will be available in September 2019) will confirm whether TEAS before and during anesthesia could alleviate the postoperative pulmonary complications after gastrointestinal surgery in elderly patients, and whether dual-acupoint stimulation is more effective than single-acupoint stimulation. TRIALS REGISTRATIONS: ClinicalTrials.gov, ID: NCT03230045 . Registered on 10 July 2017.

A spirituality teaching program for depression: a randomized controlled trial.

OBJECTIVE: This randomized controlled trial assessed the efficacy of a Spirituality Teaching Program to treat unipolar major depression. METHOD: A randomized controlled, assessor blinded trial design was used. A total of 84 individuals aged 18 years or older with unipolar major depression of mild to moderate severity were recruited in Calgary, Canada and randomized to two study arms: 1) Spirituality Teaching Program Group (8 week, home-based Spirituality Teaching Program); and 2) Waitlist Control Group (no intervention followed by Spirituality Teaching Program starting at week 9). Outcome measures (depression severity, response rate, remission rate) were assessed at baseline, 8, 16, and 24 weeks using the Hamilton Depression Rating Scale (HAM-D). RESULTS: The two trial groups were similar in their demographic and disease characteristics at baseline. At the 8-week point, the change in depression severity was significantly different between the two groups (change in HAM-D score: 8.5 for the Spirituality Group and 2.3 for the Waitlist Control Group, p < 0.001). The Spirituality Teaching Program Group had significantly higher response (36% vs. 4.4%, p < 0.001) and remission rates (31% vs. 4.4%, p < 0.001) than the Waitlist Control Group. The benefits remained throughout the observation period for the Spirituality Teaching Program Group participants with response rates of 56.4% at 16 weeks and 58.9% at 24 weeks. CONCLUSION: The Spirituality Program significantly reduced depression severity and increased response and remission rates. This non-drug treatment program should be investigated further as a treatment option for depression.