Clinical trial NCT04266886: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Female Reproductive System Neoplasm
Recurrent Malignant Female Reproductive System Neoplasm
Metastatic Cervical Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-12
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of participating in pre-operative self-hypnosis
timeFrame: Up to 1 day
measure: Patients' perception of post-surgical pain
timeFrame: Post-operative day 1 (POD1)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Larissa A Meyer
role: PRINCIPAL_INVESTIGATOR
References: