M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT04266886
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Interventional
Not applicable
Houston, Texas, 77030, United States
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 and other baseline demographic, medical, and psychosocial variables are related to or influence outcomes over time including preoperative anxiety and postoperative outcomes (e.g., MEDD, LOS, complications, symptoms, and QOL).
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive usual care
Other names: standard of care, standard therapy
Receive self-hypnosis guided relaxation
Other names: Clinical Hypnosis, Hypnosis
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Time frame: Up to 1 day
Will assess proportion of participants who listen to the complete audio file in the preoperative holding area.
Time frame: Post-operative day 1 (POD1)
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.
M.D. Anderson Cancer Center
Other
Integration of Self-Hypnosis in an Enhanced Recovery After Surgery (ERAS) Program: A Prospective Randomized Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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