NCT04266886

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 and other baseline demographic, medical, and psychosocial variables are related to or influence outcomes over time including preoperative anxiety and postoperative outcomes (e.g., MEDD, LOS, complications, symptoms, and QOL). 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.

Conditions

• Malignant Female Reproductive System Neoplasm
• Recurrent Malignant Female Reproductive System Neoplasm
• Metastatic Cervical Cancer

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
PROCEDURE	Hypnotherapy	Receive self-hypnosis guided relaxation
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-09-11
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-02-12
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States