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Self-Hypnosis for Recovery After Surgery in Female Reproductive System Cancer

N/A

Waitlist Available

Led By Larissa A Meyer

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs

Patient must be able to read, understand, and speak English

Must not have

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

Patients undergoing known/anticipated anterior abdominal wall hernia repairs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative day 1 (pod1)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effects of self-hypnosis on post-surgery recovery in gynecologic cancer patients.

Who is the study for?

This trial is for English-speaking patients scheduled for exploratory laparotomy due to suspected gynecologic cancer, who can participate in the Enhanced Recovery Pathway. They must be able to understand and consent to a randomized study and have no major psychiatric diseases or hearing impairments that would interfere with self-hypnosis.

What is being tested?

The trial is testing if self-hypnosis can improve recovery after surgery for gynecologic cancer. Patients will use guided relaxation techniques aimed at reducing pain and discomfort post-surgery. The effectiveness of this method will be compared against standard care practices.

What are the potential side effects?

Self-hypnosis is generally considered safe with minimal risk of side effects. However, it may not be suitable for individuals with certain psychiatric conditions or those who are unable to hear the guided instructions properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having surgery to explore for suspected cancer in my reproductive organs.

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I can read, understand, and speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been taking opioids regularly for the past month.

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I am scheduled for or might need surgery to fix a hernia in my belly area.

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I am scheduled for or have had a pelvic exenteration.

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I am scheduled for surgery that includes rebuilding part of my belly area.

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I had emergency surgery recently, leaving no time to review this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative day 1 (pod1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative day 1 (pod1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 1 (pod1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of participating in pre-operative self-hypnosis

Patients' perception of post-surgical pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (usual care, self-hypnosis guided relaxation)Experimental Treatment4 Interventions

Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.

Group II: Arm I (usual care)Active Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypnotherapy

2016

Completed Phase 3

~810

0 / 7Eligibility criteria met