Rectal CancerNCT07619768
Self Regulation Hypnotic Intervention for Pain and Anxiety During Rectal Brachytherapy
A study testing Self-Regulation hypnosis in people with Rectal Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
Trial summary
The goal of this study is to compare a Self-Regulation Hypnotic Intervention (SRHI) to the standard procedure (Treatment As Usual with analgesic and sedative agents) for pain and anxiety management during rectal cancer brachytherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Self-Regulation hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score over 25 on the MMSE,
- Fluent in english or french elected for brachytherapy treatment for rectal cancer
Who cannot join
- Medication for pain, anxiety or depression on a non-regular basis.
- Organic brain condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Regulation Hypnotic Intervention for Pain and Anxiety During Brachytherapy for Rectal Cancer: A Randomized Controlled Trial
The goal of this study is to compare a Self-Regulation Hypnotic Intervention (SRHI) to the standard procedure (Treatment As Usual with analgesic and sedative agents) for pain and anxiety management during rectal cancer brachytherapy. Hypnotizability of patients undergoing this procedure will be assessed and those who are thought to need analgesic and sedative agents during the procedure will be distributed (sequentially adjusted randomization) in two groups, one that will be trained and assisted using hypnosis and one that will not. Procedural pain, anxiety, difficulty and patients' vital sign will be assessed. Our hypothesis is that patients in the hypnosis group will experience less pain and anxiety and will need less medication than those in the control group.
Read the detailed description
Research question and Specific Aims:
Primary objectives of this pilot Randomized Controlled Trial are to evaluate the effects of SRHI with colorectal cancer patients receiving brachytherapy on: 1) self-reported pain and anxiety levels (measured with a self-report numeric rating scale and facial pain expression) 2) frequency and total doses of administered analgesics and sedatives, procedural length and difficulty and 3) fluctuations of vital signs (heart rate, respiratory rate, pulse oximetry and blood pressure). Ancillary measures will also be taken in order to fuel several future research projects. These include measures of anxiety, depression, personality, quality of life, self-efficacy, and brachytherapy outcome. Since the brachytherapy procedure is new and treats the most prevalent cancer, knowing if hypnosis can be used to ease the experience of patients is important. Unfortunately, research on this subject is scarce.
Study Design:
Patients deemed eligible for brachytherapy will meet the research assistant (RA) who will explain research consent form and proceed with Mini Mental State Examination. If all inclusion criteria are met, the RA will hand out a package of self-report questionnaires. All participants will be given an appointment for the hypnotizability measure. Participants will all be told that they responded well to the instructions but they will remain blind to their hypnotizability score/performance. Self-report questionnaires and hypnotizability measures must be completed before first brachytherapy session.
Eligible participants who are thought to need in-procedure pain and anxiety management will be randomized to a) those who will get the SRHI and b) those who will not (control group). All participants will be told that they would have access to as much medication as they want within safe limits.
Hence, we will have a total of two groups: I) the experimental group, participants who receive SRHI and II) participants who will act as the group control for the experimental group and will not receive the SRHI. All participants assigned to the experimental group will meet a psychologist duly trained in clinical hypnosis once for training and will be continually assisted during the intervention (see Intervention section).
Hypnotisability measure will be verified by an inter-rater reliability measure. Twenty-five percent (25%) of the administrations will be scored by an independent coder. For the patients in the standard procedure and those in the control group, the medical staff will be instructed to behave naturally the same way they usually do during the procedure in terms of comforting the patient, but to refrain from giving imagery relaxation and hypnotic inductions.
Participants of both groups will be administered pharmacological assistance to manage pain and anxiety if they ask for it. All participants will be free to withdraw from the study at any time. The staff will keep track of dosage, type of medication administered and procedural time of administration. The pain and anxiety will be assessed just before the beginning of the procedure, at the insertion of the applicator and every 15 minutes during the procedure. Pain and anxiety levels will also be noted each time the patients ask medication. To ensure that the study is secure and ethic, usual medical interventions will be performed by the chief radio-oncologist if any adverse event occurs.
Self Regulation Hypnotic Intervention:
The intervention will consist of a modification of a hypnotic relaxation script tailored to fit the unique characteristics of rectal brachytherapy and patients' experience of anxiety, pain intensity and unpleasantness. An experienced psychologist will direct a 40 minutes individual session providing hypnotic analgesia intervention before the brachytherapy procedure. A 10 minutes rehearsal will be done each day prior treatment. Furthermore, the psychologist will deliver the hypnotic intervention during each of the four treatment days. The hypnotic intervention will follow the clinical features (i.e. insertion of the applicator) of the procedure as cued by the treating physician.
- Conditions
- Rectal Cancer
- Being tested
- Self-Regulation hypnosis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Regulation hypnosisBehavioural
A psychologist specialised in clinical hypnosis teaches patients to use self-hypnosis and guides them through their treatment
| Study group | Role | What they receive |
|---|---|---|
| Self-Regulation Hypnotic intervention | Experimental | The participants meet a psychologist and a research assistant for about 15 minutes to learn information about the study and hypnosis. Once the consent is signed, their hypnotizability level and general mental state is assessed. After that, the psychologist (experienced in clinical hypnosis) teaches patients how to use self-hypnosis during 40 minutes prior to treatment, and guides them throughout their treatment. Receives: Behavioral: Self-Regulation hypnosis |
| Treatment As Usual | No intervention | The participants meet a psychologist and a research assistant for about 15 minutes to learn information about the study and hypnosis. Once the consent is signed, their hypnotizability level and general mental state is assessed. After that, participants go on to their treatment with no additional intervention, but a research assistant collects data throughout their treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Anxiety Self Report
Participant's self-reports of pain and anxiety will be obtained through the use of verbal Numeric Rating Scales (NRS) from 0 (no pain, no anxiety) to 10 (worst possible pain, worst possible anxiety). These scales are currently implemented at the Jewish General Hospital (JGH) , and the NRS for pain is recommended for use in clinical trials and in clinical guidelines for cancer-related pain .
Measured: Perioperative/Periprocedural
Vital Signs
Vital signs will be continuously recorded with a data collection computer (Moberg Research Inc., USA) connected to the patient's portable monitor (Philips Intellivue MP50) in the brachytherapy room using a serial-port cable, and specific events (i.e., before, during, and after brachytherapy) will be marked. Means of all vital signs will be calculated for one-minute duration at specific times as described in the procedure section.
Measured: Perioperative/Periprocedural
Facial expressions of pain checklist
Facial expressions of pain will be video recorded during brachytherapy using a behavioral checklist developed by one of the coinvestigator (Céline Gélinas). This checklist is a combination of two previously validated behavioral pain assessment tools i.e. the Pain Behavior Assessment Tool (PBAT;) and the Critical-Care Pain Observation Tool. The Facial Expression section includes 16 dichotomized items (yes/no).
Measured: Perioperative/Periprocedural
Secondary outcomes (9)
The Hypnotizability Induction Profile
This is a short scale for the measurement of hypnotic responsiveness . The score of hypnotizability trait varies from 0 not hypnotizable to 10 extremely hypnotizable. The HIP takes 5 to 7 minutes to be completed and will be administered on site by a trained research assistant.
Measured: At recruitment
The Short Form 36 Health Survey Questionnaire (SF-36)
The SF-36 has extensive evidence for its validity and reliability in multiple populations. It consists of 8 domains, including physical functioning, social functioning, role limitations related to physical problems, role limitations related to emotional problems, mental health, vitality, bodily pain, and general health perceptions. Each domain can be scored separately, with scores ranging from 0 (the worst health state) to 100 (the best health state). Domain scores can also be summarized into summary scores, scored using norm-based scoring based on a general population sample to produce T scores for each patient (mean of 50 and standard deviation of 10). Version 2 of the SF-36 will be used in this study.
Measured: Change from Before brachytherapy treatment to one month after surgery
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 and the supplemental for Colorectal 29 (EORTC-QLQ-C30 & EORTC-QLQ-CR29)
This is a 30 + 29-item self-report questionnaire widely used worldwide and validated in 81 languages. It assesses core domains of health related quality of life in cancer patients and specific domains for colorectal cancer patients.
Measured: Change from Before brachytherapy treatment to one month after surgery
The Patient Health Questionnaire 9 scale (PHQ-9)
This is a nine-item self-report measure of depression severity. Scores of 5, 10, 15 and 20 represent cut offs for the lower limits of mild, moderate, moderately severe and severe depression. A score of 10 or greater is recommended as a screening cut-off point. The PHQ-9 has been shown to be valid and reliable.
Measured: Change from Before brachytherapy treatment to one month after surgery
The Generalised Anxiety Disorder 7 scale (GAD-7)
This is a seven-item self-report measure of anxiety severity. A score of 10 or greater on the GAD-7 represents a screening cut point for identifying cases of GAD. Similar to the PHQ-9, cut off scores of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety on the GAD-7.
Measured: Change from Before brachytherapy treatment to one month after surgery
The Type D Scale-14 (DS14)
This is a 14-item questionnaire measuring Type D or ''distressed'' personality style, that has been primarily validated among patients with cardiovascular disease. However, this scale has been used with patients with different types of major illnesses and among them patients with colorectal cancer [38]. There are two subscales: negative affectivity and social inhibition. Subjects endorse items on a 5-point Likert scale, and those who score 10 points or more on both dimensions are classified as having a Type D personality. Must be validated in Quebec.
Measured: Change from Before brachytherapy treatment to one month after surgery
The NEO Five-Factor Inventory-3 (NEO-FFI-3)
This is a brief version of the NEO-PI-3 and is composed of 60 self-report items divided into 5 subscales of 12 items each. This questionnaire provides a quick, reliable and accurate measure of the five domains of personality (neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness) and is particularly useful when time is limited and when global information on personality is needed.
Measured: Change from Before brachytherapy treatment to one month after surgery
Procedural difficulty
The radiation oncologist will rate the difficulty experienced in placing the instrument due to patient movement or resistance using a 4-point scale (1 = not at all difficult, 2 = mildly difficult, 3 = moderately difficult, 4 = very difficult)[40].
Measured: Perioperative/Periprocedural
The Coping with Health Injuries and Problems (CHIP)
This is a 32 item self-report inventory that assesses coping strategies during the development or treatment of a health problem. The items are rated on a five point scale. In psychosocial health research, assessing coping styles is important because coping has been reported to play a mediating role between stress and illness. This inventory evaluates basic coping styles through four different scales: instrumental (Cronbach α ranging between .70 and .82), palliative (α ranging between .72 and .81, distraction (α ranging between .74 and .81) and emotional preoccupation (α ranging between .81 and .88). It takes between five and ten minutes to complete and it has been validated in French-Canadian cancer patient samples. It has also been used in French-Canadian women with breast cancer to assess passive (palliative and emotional combined) and active coping(distraction and instrumental combined), with Cronbach α of .76 and .79, respectively.
Measured: Change from Before brachytherapy treatment to one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startJul 2013
- Primary completionSep 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Te Vuong, MD, Principal investigator, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619768
- Sponsor's protocol ID
- SRHI rectal brachy
- Status last verified
- Apr 2016
- First submitted
- 16 Nov 2015
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Regulation Hypnotic Intervention for Pain and Anxiety During Brachytherapy for Rectal Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07619768
- Acronym / sponsor ID
- SRHI rectal brachy
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Jun 2026 (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.
The goal of this study is to compare a Self-Regulation Hypnotic Intervention (SRHI) to the standard procedure (Treatment As Usual with analgesic and sedative agents) for pain and anxiety management during rectal cancer brachytherapy. Hypnotizability of patients undergoing this procedure will be assessed and those who are thought to need analgesic and sedative agents during the procedure will be distributed (sequentially adjusted randomization) in two groups, one that will be trained and assisted using hypnosis and one that will not. Procedural pain, anxiety, difficulty and patients' vital sign will be assessed. Our hypothesis is that patients in the hypnosis group will experience less pain and anxiety and will need less medication than those in the control group.
Detailed description
Research question and Specific Aims:
Primary objectives of this pilot Randomized Controlled Trial are to evaluate the effects of SRHI with colorectal cancer patients receiving brachytherapy on: 1) self-reported pain and anxiety levels (measured with a self-report numeric rating scale and facial pain expression) 2) frequency and total doses of administered analgesics and sedatives, procedural length and difficulty and 3) fluctuations of vital signs (heart rate, respiratory rate, pulse oximetry and blood pressure). Ancillary measures will also be taken in order to fuel several future research projects. These include measures of anxiety, depression, personality, quality of life, self-efficacy, and brachytherapy outcome. Since the brachytherapy procedure is new and treats the most prevalent cancer, knowing if hypnosis can be used to ease the experience of patients is important. Unfortunately, research on this subject is scarce.
Study Design:
Patients deemed eligible for brachytherapy will meet the research assistant (RA) who will explain research consent form and proceed with Mini Mental State Examination. If all inclusion criteria are met, the RA will hand out a package of self-report questionnaires. All participants will be given an appointment for the hypnotizability measure. Participants will all be told that they responded well to the instructions but they will remain blind to their hypnotizability score/performance. Self-report questionnaires and hypnotizability measures must be completed before first brachytherapy session.
Eligible participants who are thought to need in-procedure pain and anxiety management will be randomized to a) those who will get the SRHI and b) those who will not (control group). All participants will be told that they would have access to as much medication as they want within safe limits.
Hence, we will have a total of two groups: I) the experimental group, participants who receive SRHI and II) participants who will act as the group control for the experimental group and will not receive the SRHI. All participants assigned to the experimental group will meet a psychologist duly trained in clinical hypnosis once for training and will be continually assisted during the intervention (see Intervention section).
Hypnotisability measure will be verified by an inter-rater reliability measure. Twenty-five percent (25%) of the administrations will be scored by an independent coder. For the patients in the standard procedure and those in the control group, the medical staff will be instructed to behave naturally the same way they usually do during the procedure in terms of comforting the patient, but to refrain from giving imagery relaxation and hypnotic inductions.
Participants of both groups will be administered pharmacological assistance to manage pain and anxiety if they ask for it. All participants will be free to withdraw from the study at any time. The staff will keep track of dosage, type of medication administered and procedural time of administration. The pain and anxiety will be assessed just before the beginning of the procedure, at the insertion of the applicator and every 15 minutes during the procedure. Pain and anxiety levels will also be noted each time the patients ask medication. To ensure that the study is secure and ethic, usual medical interventions will be performed by the chief radio-oncologist if any adverse event occurs.
Self Regulation Hypnotic Intervention:
The intervention will consist of a modification of a hypnotic relaxation script tailored to fit the unique characteristics of rectal brachytherapy and patients' experience of anxiety, pain intensity and unpleasantness. An experienced psychologist will direct a 40 minutes individual session providing hypnotic analgesia intervention before the brachytherapy procedure. A 10 minutes rehearsal will be done each day prior treatment. Furthermore, the psychologist will deliver the hypnotic intervention during each of the four treatment days. The hypnotic intervention will follow the clinical features (i.e. insertion of the applicator) of the procedure as cued by the treating physician.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Regulation Hypnotic intervention | Experimental | Behavioral: Self-Regulation hypnosisThe participants meet a psychologist and a research assistant for about 15 minutes to learn information about the study and hypnosis. Once the consent is signed, their hypnotizability level and general mental state is assessed. After that, the psychologist (experienced in clinical hypnosis) teaches patients how to use self-hypnosis during 40 minutes prior to treatment, and guides them throughout their treatment. |
| Treatment As Usual | No intervention | –The participants meet a psychologist and a research assistant for about 15 minutes to learn information about the study and hypnosis. Once the consent is signed, their hypnotizability level and general mental state is assessed. After that, participants go on to their treatment with no additional intervention, but a research assistant collects data throughout their treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Score over 25 on the MMSE,
- Fluent in english or french elected for brachytherapy treatment for rectal cancer
Key exclusion criteria (2 listed)
- Medication for pain, anxiety or depression on a non-regular basis.
- Organic brain condition
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 |
|---|---|---|
| Self-Regulation hypnosisA psychologist specialised in clinical hypnosis teaches patients to use self-hypnosis and guides them through their treatment | Behavioural | Self-Regulation Hypnotic intervention |
Primary outcome
Pain and Anxiety Self Report
Time frame: Perioperative/Periprocedural
Participant's self-reports of pain and anxiety will be obtained through the use of verbal Numeric Rating Scales (NRS) from 0 (no pain, no anxiety) to 10 (worst possible pain, worst possible anxiety). These scales are currently implemented at the Jewish General Hospital (JGH) , and the NRS for pain is recommended for use in clinical trials and in clinical guidelines for cancer-related pain .
Vital Signs
Time frame: Perioperative/Periprocedural
Vital signs will be continuously recorded with a data collection computer (Moberg Research Inc., USA) connected to the patient's portable monitor (Philips Intellivue MP50) in the brachytherapy room using a serial-port cable, and specific events (i.e., before, during, and after brachytherapy) will be marked. Means of all vital signs will be calculated for one-minute duration at specific times as described in the procedure section.
Facial expressions of pain checklist
Time frame: Perioperative/Periprocedural
Facial expressions of pain will be video recorded during brachytherapy using a behavioral checklist developed by one of the coinvestigator (Céline Gélinas). This checklist is a combination of two previously validated behavioral pain assessment tools i.e. the Pain Behavior Assessment Tool (PBAT;) and the Critical-Care Pain Observation Tool. The Facial Expression section includes 16 dichotomized items (yes/no).
9 secondary outcomes
The Hypnotizability Induction Profile
Time frame: At recruitment
The Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: Change from Before brachytherapy treatment to one month after surgery
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 and the supplemental for Colorectal 29 (EORTC-QLQ-C30 & EORTC-QLQ-CR29)
Time frame: Change from Before brachytherapy treatment to one month after surgery
The Patient Health Questionnaire 9 scale (PHQ-9)
Time frame: Change from Before brachytherapy treatment to one month after surgery
The Generalised Anxiety Disorder 7 scale (GAD-7)
Time frame: Change from Before brachytherapy treatment to one month after surgery
The Type D Scale-14 (DS14)
Time frame: Change from Before brachytherapy treatment to one month after surgery
The NEO Five-Factor Inventory-3 (NEO-FFI-3)
Time frame: Change from Before brachytherapy treatment to one month after surgery
Procedural difficulty
Time frame: Perioperative/Periprocedural
The Coping with Health Injuries and Problems (CHIP)
Time frame: Change from Before brachytherapy treatment to one month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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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.
Te Vuong, MD principal investigator
Sir Mortimer B. Davis - Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Regulation hypnosis in people with Rectal Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jun 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain and Anxiety Self Report (time frame: Perioperative/Periprocedural). The study lists 3 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 2 Jun 2026.