Malignant Female Reproductive System Neoplasm Clinical Trial
Official title:
Integration of Self-Hypnosis in an Enhanced Recovery After Surgery (ERAS) Program: A Prospective Randomized Trial
This trial studies how well self-hypnosis works in enhancing recovery after surgery in patients with gynecologic cancer. A guided relaxation method called self-hypnosis may help affect how patients feel pain and symptoms after surgery.
PRIMARY OBJECTIVE: I. To evaluate whether participation in pre-operative self-hypnosis (SH) is feasible and will improve patients' perception of post-surgical pain, after undergoing open gynecologic surgery (laparotomy) on an enhanced recovery pathway. SECONDARY OBJECTIVES: I. To evaluate whether participation in pre-operative SH is associated with changes in use of opioid medication, including time to first postoperative opioid and total dose of opioids taken (converted to morphine equivalents) and avoidance of opioids. II. To explore whether participation in pre-operative SH is associated with changes in length of stay. III. To explore whether there are differences between the two study arms in other common symptoms of women undergoing gynecologic surgery, functional recovery after surgery and quality of life (QOL). IV. To explore whether expectations regarding symptom management or hypnotic susceptibility are related to or influence the perception of symptoms after surgery. V. To measure satisfaction with the intervention (patients on arm 2). VI. To perform sub analyses to explore whether other common clinical or demographic factors are potential covariates. EXPLORATORY OBJECTIVE: I. To compare two different instruments measuring patient reported outcomes in hospital postoperative recovery. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive usual care including receipt of multi-modal analgesia and the injection of a local analgesic at the time of surgery on the enhanced recovery after surgery (ERAS) pathway. ARM II: Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway. ;
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