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NCT Number: NCT04266886

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

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.

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This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
  • Planned participation in the Gynecologic Enhanced Recovery Pathway
  • Patient must be able to read, understand, and speak English
  • Consents to being part of a randomized study
  • Patient has physical and mental capabilities to take part in study

Exclusion criteria

  • Sensitivity to amide-type local anesthetics
  • Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
  • Emergency surgery of any type that does not allow for proper time for protocol review by the patient
  • Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
  • Patients undergoing known/anticipated anterior abdominal wall hernia repairs
  • Patients undergoing pelvic exenteration
  • Patients with known major psychiatric disease
  • Patients with hearing impairment such that they are unable to hear the intervention

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

hypnotherapy

Procedure

Receive self-hypnosis guided relaxation

Other names: Clinical Hypnosis, Hypnosis

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility of participating in pre-operative self-hypnosis

    Time frame: Up to 1 day

    Will assess proportion of participants who listen to the complete audio file in the preoperative holding area.

  2. Patients' perception of post-surgical pain

    Time frame: Post-operative day 1 (POD1)

    Will summarize POD1 pain scores for each treatment arm using descriptive statistics. Will use a Wilcoxon rank sums test to determine if the POD1 pain scores in the self-hypnosis arm are lower than the usual care arm. Pain intensity score from 0 to 10.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2020
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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