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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-08222 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0143 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larissa A Meyer | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Hypnotherapy | Procedure | Receive self-hypnosis guided relaxation |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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