Malignant Female Reproductive System NeoplasmNCT04266886
Self-Hypnosis for the Enhanced Recovery After Surgery in Patients With Gynecologic Cancer
A study testing Best Practice, Hypnotherapy and Quality-of-Life Assessment in people with Malignant Female Reproductive System Neoplasm and Recurrent Malignant Female Reproductive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Metastatic Cervical Cancer
- What is being tested?
- Best Practice, Hypnotherapy and Quality-of-Life Assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integration of Self-Hypnosis in an Enhanced Recovery After Surgery (ERAS) Program: A Prospective Randomized Trial
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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).
- 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:
- 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.
- Conditions
- Malignant Female Reproductive System Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Metastatic Cervical Cancer
- Being tested
- Best Practice, Hypnotherapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
HypnotherapyProcedure or surgery
Also called Clinical Hypnosis, Hypnosis
Receive self-hypnosis guided relaxation
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Procedure: Hypnotherapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-operative day 1 (POD1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start11 Sep 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Larissa A Meyer, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266886
- Sponsor's protocol ID
- 2018-0143
- Other IDs
- NCI-2019-08222, 2018-0143
- Status last verified
- Sep 2026
- First submitted
- 30 Dec 2019
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Self-Hypnosis in an Enhanced Recovery After Surgery (ERAS) Program: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04266886
- Acronym / sponsor ID
- 2018-0143
- Conditions
- Malignant Female Reproductive System Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Metastatic Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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).
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
| Arm II (usual care, self-hypnosis guided relaxation) | Experimental | Other: Best Practice, Procedure: Hypnotherapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm I (usual care), Arm II (usual care, self-hypnosis guided relaxation) |
| HypnotherapyAlso: Clinical Hypnosis, HypnosisReceive self-hypnosis guided relaxation | Procedure or surgery | Arm II (usual care, self-hypnosis guided relaxation) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (usual care), Arm II (usual care, self-hypnosis guided relaxation) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (usual care), Arm II (usual care, self-hypnosis guided relaxation) |
Primary outcome
Feasibility of participating in pre-operative self-hypnosis
Time frame: Up to 1 day
Will assess proportion of participants who listen to the complete audio file in the preoperative holding area.
Patients' perception of post-surgical pain
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa A Meyer principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Hypnotherapy and Quality-of-Life Assessment in people with Malignant Female Reproductive System Neoplasm and Recurrent Malignant Female Reproductive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of participating in pre-operative self-hypnosis (time frame: Up to 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.