Gynecologic oncology · 2025
Integration of self-hypnosis in an enhanced recovery after surgery program in gynecologic oncology - A prospective randomized trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
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Iniesta Maria D, Ramirez Pedro T, Munsell Mark F, Basabe Sol, Shen Shu-En, Cain Katherine E, Shafer Aaron, Lasala Javier, Mena Gabriel, Wang Xin S, Cohen Lorenzo, Meyer Larissa
Аннотация
OBJECTIVE: To evaluate whether adding self-hypnosis (SH) to our enhanced recovery after surgery (ERAS) pathway was feasible and could improve patient-reported pain.
METHODS: Patients undergoing exploratory laparotomy were randomized to ERAS or ERAS+SH. Patients in the ERAS+SH arm were asked to listen a SH audio file in the preoperative holding area. Feasibility endpoint was defined as 60 % of patients listening to the audio in the preoperative holding area. Primary effectiveness outcome was patient-reported worst pain on postoperative day 1. Secondary outcomes included patient-reported anxiety, quality of life, symptom burden, time to first opioid, morphine equivalent daily dose after surgery, and satisfaction with the SH experience.
RESULTS: 152 patients were randomized and 138 underwent open gynecologic surgery and were evaluable: 67 (48.6 %) to ERAS and 71 (51.4 %) to ERAS+SH. Incorporation of SH was considered feasible with 77.5 % of patients listening to the entire audio file in the holding area. The study was closed prematurely before achieving the N = 224 sample size due to futility in achieving the primary effectiveness outcome. There were no significant group differences in patient-reported worst pain on postoperative day 1, median morphine equivalents during admission or time to first opioid after surgery. In the ERAS+SH arm, there was a 2-point decrease (median score of 2; IQR 1-3; p < 0.001) in anxiety scores after the SH intervention. Median scores on satisfaction questions were 8/10 or above.
CONCLUSIONS: Incorporating SH to an ERAS pathway was feasible with high levels of satisfaction. While the SH intervention statistically and clinically significantly decreased self-reported anxiety, there was no improvement in self-reported pain, quality of life, time to first opioid, or opioid consumption during admission.
METHODS: Patients undergoing exploratory laparotomy were randomized to ERAS or ERAS+SH. Patients in the ERAS+SH arm were asked to listen a SH audio file in the preoperative holding area. Feasibility endpoint was defined as 60 % of patients listening to the audio in the preoperative holding area. Primary effectiveness outcome was patient-reported worst pain on postoperative day 1. Secondary outcomes included patient-reported anxiety, quality of life, symptom burden, time to first opioid, morphine equivalent daily dose after surgery, and satisfaction with the SH experience.
RESULTS: 152 patients were randomized and 138 underwent open gynecologic surgery and were evaluable: 67 (48.6 %) to ERAS and 71 (51.4 %) to ERAS+SH. Incorporation of SH was considered feasible with 77.5 % of patients listening to the entire audio file in the holding area. The study was closed prematurely before achieving the N = 224 sample size due to futility in achieving the primary effectiveness outcome. There were no significant group differences in patient-reported worst pain on postoperative day 1, median morphine equivalents during admission or time to first opioid after surgery. In the ERAS+SH arm, there was a 2-point decrease (median score of 2; IQR 1-3; p < 0.001) in anxiety scores after the SH intervention. Median scores on satisfaction questions were 8/10 or above.
CONCLUSIONS: Incorporating SH to an ERAS pathway was feasible with high levels of satisfaction. While the SH intervention statistically and clinically significantly decreased self-reported anxiety, there was no improvement in self-reported pain, quality of life, time to first opioid, or opioid consumption during admission.