CancerPhase 2HYCUDESNCT03755895
Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients
A Phase 2 study testing formal hypnosis and Kalinox in people with Cancer and Brachytherapy, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the preoperative procedure. In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for patients treated for prostate cancer The goal of the study is to demonstrate the added value of hypnosis during a… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Brachytherapy
- What is being tested?
- formal hypnosis and Kalinox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2019to 25 May 2022
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 and ≤ 80 years
- Patients expected to benefit a brachytherapy detachment Under KALINOX® for one of the types of applications described below:
- Deep interstitial application: anal canal, vagina, vulva
- Gynecological application: mold, Utrecht® system or Venezia® system
- Ability to provide written informed consent
- Patients affiliated to the social security system
Who cannot join
- Minor and patients over 80 years old
- Patients with major hearing loss
- Patients who had recent ocular surgery with oculiare gas injection.
- Patients suffering from psychotic disorders, and dementias.
- Patients who do not understand the French language
- Patients under guardianship or deprived of liberty
- Patients with a contraindication to the administration of KALINOX®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing the Hypnosis Versus Standard Care of Anxiety and Pain in Patients With Brachytherapy
Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the preoperative procedure.
In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for patients treated for prostate cancer The goal of the study is to demonstrate the added value of hypnosis during a brachytherapy detachment by improving the comfort of the patient.
The investigators want to evaluate the contribution of hypnosis during brachytherapy detachment by quantifying the anxiety and pain felt by the patient during the procedure.
- Conditions
- Cancer, Brachytherapy
- Being tested
- formal hypnosis, Kalinox
- Keywords
- Cancer, hypnosis, care management
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formal hypnosisOther
patients will have brachytherapy detachment under Kalinox and formal hypnosis
KalinoxDrug
patients will have brachytherapy detachment under Kalinox
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis Receives: Other: formal hypnosis; Drug: Kalinox |
| active comparator | Active comparator | patients to benefit from brachytherapy detachment under KALINOX Receives: Drug: Kalinox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety evaluation
The patient's anxiety will be assessed using the State-Trait Anxiety Inventory scale ("state of anxiety") before premedication (in the bedroom) and immediately after the brachytherapy detachment (in the examination room) during brachytherapy detachment using two care management: standard care versus standard care with formal hypnosis. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger et al, 1983). The scale include 20 items. Higher scores indicate greater anxiety
Measured: 1day
Secondary outcomes (5)
Pain evaluation: numeric scale
Pain will be evaluated by a numeric scale before premedication (in the room), just before and just after the brachytherapy detachment (in the examination room). Patient inform their level of pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain
Measured: 1 day
Anxiety evaluation
Anxiety will be evaluated by a numeric scale just before and just after the brachytherapy detachment. Patient inform their level of anxiety from 0 to 10 (11 point scale) with the understanding that 0 is equal to no anxiety and 10 is equal to worst possible anxiety
Measured: 1 day
Patient's perception of the care
The patient's perception of the care will be evaluated by a semi-directive phone interview conducted by the medical staff between day 3 and day 5 after the brachytherapy detachment
Measured: 1day
Time of brachytherapy detachment
The time of brachytherapy detachment will be noted from the entrance to the patient's examination room until the end of the brachytherapy detachment
Measured: 1day
Realization of the brachytherapy detachment
The ease of realization of the brachytherapy detachment and the comfort of the medical staff will be evaluated by an numeric scale at the end of the care and by a self-survey
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start2 Nov 2019
- Primary completion17 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie RENARD, Md, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755895
- Sponsor's protocol ID
- 2018-004527-37
- Other IDs
- 2018
- Acronym
- HYCUDES
- Status last verified
- Aug 2026
- First submitted
- 26 Nov 2018
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemoine L, Adam V, Salleron J, Cuisinier C, Perrin J, Brunaud CC, Jean-Francois P, Bruand M, Peiffert D, Etienne R, Schohn CH, Renard S. Randomized trial comparing hypnosis versus standard management on patient anxiety and pain during pelvic brachytherapy applicator removal. Brachytherapy. 2025 Nov-Dec;24(6):854-862. doi: 10.1016/j.brachy.2025.07.010. Epub 2025 Aug 28.
PubMed 40883194
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing the Hypnosis Versus Standard Care of Anxiety and Pain in Patients With Brachytherapy
- ClinicalTrials.gov ID
- NCT03755895
- Acronym / sponsor ID
- HYCUDES / 2018-004527-37
- Conditions
- Cancer, Brachytherapy
- Keywords
- Cancer, hypnosis, care management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 28 Nov 2018 (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.
Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the preoperative procedure.
In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for patients treated for prostate cancer The goal of the study is to demonstrate the added value of hypnosis during a brachytherapy detachment by improving the comfort of the patient.
The investigators want to evaluate the contribution of hypnosis during brachytherapy detachment by quantifying the anxiety and pain felt by the patient during the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: formal hypnosis, Drug: Kalinoxpatients to benefit from brachytherapy detachment under KALINOX and formal hypnosis |
| active comparator | Active comparator | Drug: Kalinoxpatients to benefit from brachytherapy detachment under KALINOX |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients ≥ 18 and ≤ 80 years
- Patients expected to benefit a brachytherapy detachment Under KALINOX® for one of the types of applications described below:
- Ability to provide written informed consent
- Patients affiliated to the social security system
Key exclusion criteria (7 listed)
- Minor and patients over 80 years old
- Patients with major hearing loss
- Patients who had recent ocular surgery with oculiare gas injection.
- Patients suffering from psychotic disorders, and dementias.
- Patients who do not understand the French language
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 |
|---|---|---|
| formal hypnosispatients will have brachytherapy detachment under Kalinox and formal hypnosis | Other | experimental |
| Kalinoxpatients will have brachytherapy detachment under Kalinox | Drug | active comparator, experimental |
Primary outcome
Anxiety evaluation
Time frame: 1day
The patient's anxiety will be assessed using the State-Trait Anxiety Inventory scale ("state of anxiety") before premedication (in the bedroom) and immediately after the brachytherapy detachment (in the examination room) during brachytherapy detachment using two care management: standard care versus standard care with formal hypnosis. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger et al, 1983). The scale include 20 items. Higher scores indicate greater anxiety
5 secondary outcomes
Pain evaluation: numeric scale
Time frame: 1 day
Anxiety evaluation
Time frame: 1 day
Patient's perception of the care
Time frame: 1day
Time of brachytherapy detachment
Time frame: 1day
Realization of the brachytherapy detachment
Time frame: 1day
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 1 Sep 2026.
- Results publication: PubMed 40883194Lemoine L, Adam V, Salleron J, Cuisinier C, Perrin J, Brunaud CC, Jean-Francois P, Bruand M, Peiffert D, Etienne R, Schohn CH, Renard S. Randomized trial comparing hypnosis versus standard management on patient anxiety and pain during pelvic brachytherapy applicator removal. Brachytherapy. 2025 Nov-Dec;24(6):854-862. doi: 10.1016/j.brachy.2025.07.010. Epub 2025 Aug 28.
- Individual participant dataSharing planned: No
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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.
Sophie RENARD, Md principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing formal hypnosis and Kalinox in people with Cancer and Brachytherapy, run by Institut de Cancérologie de Lorraine at 1 site in France.
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 6 inclusion and 7 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 1 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anxiety evaluation (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755895, which also lists 1 linked publication.
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 1 Sep 2026.