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Spots Global Cancer Trial Database for Self-Hypnosis for the Enhanced Recovery After Surgery in Patients With Gynecologic Cancer

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Trial Identification

Brief Title: Self-Hypnosis for the Enhanced Recovery After Surgery in Patients With Gynecologic Cancer

Official Title: Integration of Self-Hypnosis in an Enhanced Recovery After Surgery (ERAS) Program: A Prospective Randomized Trial

Study ID: NCT04266886

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

M D Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Larissa A Meyer

Affiliation: M.D. Anderson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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