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

Overseen By Larissa A. Meyer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Opioids

Disqualifiers: Psychiatric disease, Hearing impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether self-hypnosis can aid recovery for women after surgery for gynecologic cancer. It examines if listening to a guided relaxation recording reduces pain and other symptoms compared to standard post-surgery care. Participants will either follow the regular recovery plan or add self-hypnosis to it. Women undergoing exploratory surgery for suspected gynecologic cancer who understand English may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods that could enhance the post-surgery experience.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who have been on long-acting opioids or frequent short-acting opioids recently. It's best to discuss your specific medications with the trial team.

What prior data suggests that self-hypnosis is safe for enhancing recovery after surgery?

Research shows that patients usually find self-hypnosis easy to manage. Studies have found that it can help reduce pain, anxiety, and fatigue after surgery. It has been used without causing major side effects, suggesting that self-hypnosis is a safe option for surgical recovery. While hypnosis has been used in various situations, discussing options with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about self-hypnosis for recovery after surgery in female reproductive system cancer because it offers a unique, non-drug approach to managing post-surgical recovery. Unlike traditional methods that rely heavily on medications for pain management, self-hypnosis uses guided relaxation techniques to help patients control pain and stress naturally. This method could potentially reduce the need for pain medication, minimizing side effects and enhancing the overall recovery experience. By empowering patients with a simple, self-directed tool, this approach may lead to faster recovery times and improved quality of life.

What evidence suggests that self-hypnosis is effective for recovery after gynecologic cancer surgery?

Studies have shown that self-hypnosis can help reduce anxiety in patients before gynecologic surgery. However, while it alleviates anxiety, it does not significantly affect post-surgery pain. In this trial, some participants will receive usual care, while others will receive usual care plus self-hypnosis guided relaxation. Self-hypnosis involves guided relaxation, helping patients feel calmer. Researchers aim to determine whether this method can also enhance recovery after surgery for patients with gynecologic cancer. Although the primary benefit appears to be anxiety reduction, its impact on overall recovery remains under investigation. ^{1 3 4 6 7}

Who Is on the Research Team?

Larissa A Meyer

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Consents to being part of a randomized study

I am planning to join the Enhanced Recovery Program for gynecologic surgery.

I am mentally and physically able to participate in the study.

Exclusion Criteria

I have been taking opioids regularly for the past month.

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

I am scheduled for or have had a pelvic exenteration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants engage in pre-operative self-hypnosis to prepare for surgery

1 day

1 visit (in-person)

Surgery and Immediate Recovery

Participants undergo open gynecologic surgery and receive usual care including multi-modal analgesia

1 day

Post-operative Recovery

Participants are monitored for post-surgical pain and recovery, including the use of self-hypnosis in Arm II

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Self-Hypnosis

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm II (usual care, self-hypnosis guided relaxation) Experimental Treatment 4 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 Control 3 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A group intervention combining self-care and self-hypnosis significantly reduced fatigue, sleep disturbances, and emotional distress in 95 female cancer survivors compared to a wait-list control group.

The positive effects of the hypnosis intervention were largely maintained one year after the treatment, suggesting potential long-term benefits for posttreatment cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Controlled Trial of an Intervention Combining Self-Care and Self-Hypnosis on Fatigue, Sleep, and Emotional Distress in Posttreatment Cancer Patients: 1-Year Follow-Up. Grégoire, C., Faymonville, ME., Vanhaudenhuyse, A., et al.[2022]

In a study of 36 head and neck cancer surgery patients, those who underwent a brief hypnosis intervention experienced significantly shorter postoperative hospital stays compared to those who received usual care without hypnosis.

Higher levels of hypnotizability in patients were associated with fewer surgical complications and less blood loss, suggesting that hypnosis may help improve surgical outcomes and reduce recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided imagery, hypnosis and recovery from head and neck cancer surgery: an exploratory study. Rapkin, DA., Straubing, M., Holroyd, JC.[2022]

A study involving 95 women with various cancer diagnoses showed that a self-hypnosis and self-care intervention significantly improved participants' quality of life, with 97.5% continuing to practice relaxation techniques after the program.

All components of the intervention, including group support and hypnosis exercises, were rated highly for their usefulness, indicating that a multicomponent approach may be effective in supporting cancer patients' self-care and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Group Intervention Combining Self-Hypnosis and Self-Care in Oncology: Implementation in Daily Life and Perceived Usefulness. Grégoire, C., Faymonville, ME., Vanhaudenhuyse, A., et al.[2023]

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