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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Female Reproductive System Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Metastatic Cervical Cancer

Intervention / Treatment
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* Other: Best Practice
* Procedure: Hypnotherapy
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (usual care)<br>Patients receive usual care including receipt of multi-modal analgesia and the injection of a local analgesic at the time of surgery on the ERAS pathway. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (usual care, self-hypnosis guided relaxation)<br>Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Procedure: Hypnotherapy<br>* Receive self-hypnosis guided relaxation<br>* Other names: Hypnosis;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of participating in pre-operative self-hypnosis | Will assess proportion of participants who listen to the complete audio file in the preoperative holding area. | Up to 1 day | 
| Patients' perception of post-surgical pain | 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. | Post-operative day 1 (POD1) |