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

Malignant Female Reproductive System Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04266886
• Other study ID #: 2018-0143
• Secondary ID: NCI-2019-0822220
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm
• Metastatic Cervical Cancer
• Neoplasms
• Recurrent Malignant Female Reproductive System Neoplasm

Intervention

Other:
• Best Practice
Receive usual care

Procedure:
• Hypnotherapy
Receive self-hypnosis guided relaxation

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)

External Links

•   MD Anderson Cancer Center Website