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

NCT04266886 | Active Not Recruiting DMC

• 2 other identifiers: 2018-0143NCI-2019-08222
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Malignant Female Reproductive System Neoplasm; Metastatic Cervical Cancer; Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Arm I (usual care)

ACTIVE COMPARATOR

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; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (usual care, self-hypnosis guided relaxation)

EXPERIMENTAL

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; Procedure: Hypnotherapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (usual care); Arm II (usual care, self-hypnosis guided relaxation)

Hypnotherapy PROCEDURE

Receive self-hypnosis guided relaxation

Also known as: Clinical Hypnosis, Hypnosis

Arm II (usual care, self-hypnosis guided relaxation)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (usual care); Arm II (usual care, self-hypnosis guided relaxation)

Questionnaire Administration OTHER

Ancillary studies

Arm I (usual care); Arm II (usual care, self-hypnosis guided relaxation)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Hypnosis

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Larissa A Meyer

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: February 12, 2020
• Study Start: September 11, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)