AnxietyHYCappNCT07476547
Hypnotic Communication To Reduce Anxiety And Pain During Prostate Biopsy (HYCapp)
A study testing Hypnotic Communication and Routine Prostate Biopsy in people with Anxiety and Pain, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial summary
This single-centre randomized controlled study (HYCapp) will evaluate whether "hypnotic communication" (a structured, non-drug communication technique delivered by health professionals trained in clinical hypnosis) can reduce anxiety and pain and improve the overall care experience in patients undergoing outpatient… Read more about this study
- Who is it for?
- Ages 40 years and older
- What is being tested?
- Hypnotic Communication and Routine Prostate Biopsy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 11 Mar 2025to 18 Feb 2026
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with an indication for outpatient prostate biopsy
- Age > 40 years
- Signed informed consent
Who cannot join
- Cognitive impairment
- Chronic pelvic pain syndrome or known perineal neuralgia
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo, Torino, 10060
About this study
Official title: The Impact Of HYpnotic Communication On Anxiety, Pain And Perception Of Care On Patients Undergoing Prostatic Biopsy: A Randomized Controlled Trial
This single-centre randomized controlled study (HYCapp) will evaluate whether "hypnotic communication" (a structured, non-drug communication technique delivered by health professionals trained in clinical hypnosis) can reduce anxiety and pain and improve the overall care experience in patients undergoing outpatient prostate biopsy.
Participants (adults aged 40 years or older scheduled for prostate biopsy at IRCCS Candiolo) will be randomly assigned 1:1 to:
Read more
Intervention group: standard prostate biopsy plus hypnotic communication provided by a trained nurse throughout the patient's pathway on the day of the procedure.
Control group: standard prostate biopsy without hypnotic communication. Local anaesthesia may be used in both groups if clinically needed. The main outcomes are patient-reported anxiety (VAS-A), pain (VAS), and satisfaction with the care experience (Likert scale 1-5), together with vital signs (heart rate and blood pressure). Assessments will be collected before the biopsy while waiting (T0) and within 30 minutes after the biopsy (T1). Additional outcomes include use of analgesic and local anaesthetic drugs, perceived versus actual procedure duration, procedure-related complications (e.g., bleeding, vasovagal reaction, fever), and time to return to usual daily/work activities.
Follow-up will include a telephone call 24-36 hours after the biopsy (T2), a questionnaire completed at home 7 days after the procedure (T3), and a further questionnaire at the visit when the histology result is communicated (approximately 20-30 days after the biopsy, T4).
The study plans to enroll 98 participants over about 1 year. Hypnotic communication is not expected to cause physical health risks; all participants will receive standard clinical care for prostate biopsy.
Read the detailed description
HYCapp is a prospective, single-centre, randomized controlled trial evaluating whether hypnotic communication-a structured, non-pharmacological communication approach delivered by a nurse trained in clinical hypnosis-can improve the peri-procedural experience of adults undergoing outpatient prostate biopsy.
Prostate biopsy is commonly associated with distress and discomfort, even when standard analgesia and local anaesthesia are available. Anxiety may amplify pain perception and worsen the overall experience of care. Hypnotic techniques have shown benefit in other procedural settings by supporting focused attention, reducing anticipatory stress, and promoting coping strategies. This trial aims to generate pragmatic evidence in a real-world urology outpatient pathway.
Participants scheduled for prostate biopsy at IRCCS Candiolo are randomized 1:1 to:
- Standard-of-care biopsy plus hypnotic communication, or
- Standard-of-care biopsy alone. Randomization is performed using a predefined allocation scheme and stratified to balance factors that may influence the patient experience and procedural characteristics (e.g., age, prostate volume, PSA, lesion site, biopsy approach, and previous biopsy history). Due to the nature of the intervention, blinding is not feasible.
Biopsy is performed according to routine practice and guideline-based standards (systematic sampling and/or targeted sampling when clinically indicated). The biopsy approach (transrectal or transperineal) and use of local anaesthesia/analgesics are decided by the clinical team and may occur in both groups.
The operational difference between groups concerns patient support and communication during the procedure:
In the intervention arm, a nurse trained in clinical hypnosis provides hypnotic communication throughout the care pathway on the day of biopsy (arrival, preparation, procedure, and immediate observation), using structured language and attention/imagery techniques; where appropriate, an anchoring phase may be used to facilitate persistence of wellbeing after the procedure, followed by re-orientation.
In the control arm, monitoring and support are provided as per standard practice by staff without hypnotic communication.
Assessments are collected at standardized timepoints: pre-procedure (baseline anxiety/stress-related measures and vital signs), immediately post-procedure (patient-reported experience measures, vital signs, documentation of medications used, perceived vs actual procedure duration, and immediate events), and during follow-up (24-36 hours by telephone, 7 days by questionnaire, and at the visit when histology results are communicated, approximately 20-30 days after biopsy). Follow-up is conducted by staff not trained as clinical hypnologists.
The planned sample size is 98 participants. Analyses will compare groups on changes over time in patient-reported experience and physiological measures, using appropriate statistical methods based on data distribution and accounting for relevant procedural covariates.
All participants receive standard clinical care. Hypnotic communication is not expected to introduce physical health risks and is intended to improve comfort and perceived quality of care during and after the biopsy. Data are handled according to applicable ethical and privacy requirements.
- Being tested
- Hypnotic Communication, Routine Prostate Biopsy
- Keywords
- Prostate biopsy, Hypnotic communication, Procedural anxiety, Procedural pain, Patient experience, Patient satisfaction, anxiety management
- Medical subject headings
- Anxiety Disorders, Pain, Pain, Procedural, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic CommunicationBehavioural
A trained nurse uses hypnotic communication throughout the biopsy procedure to support the patient and influence anxiety, pain perception, and perception of care
Routine Prostate BiopsyProcedure or surgery
Routine outpatient prostate biopsy performed according to standard practice, using a transrectal or transperineal approach as clinically indicated, with local anaesthesia if required
| Study group | Role | What they receive |
|---|---|---|
| Hypnotic Communication | Experimental | Participants undergo routine prostate biopsy and receive hypnotic communication throughout the procedure from a nurse trained in clinical hypnosis Receives: Behavioral: Hypnotic Communication |
| Routine prostate biopsy alone | Active comparator | Participants undergo routine prostate biopsy according to standard clinical practice without hypnotic communication. Receives: Procedure: Routine Prostate Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Anxiety assessed using the Visual Analogue Scale for Anxiety (VAS-A), together with vital parameters including heart rate and blood pressure
Measured: Before prostate biopsy during the waiting period (T0), within 30 minutes after biopsy (T1), 24 to 36 hours after biopsy (T2), 7 days after biopsy (T3), and at the histology result visit, approximately 20 to 30 days after biopsy (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start11 Mar 2025
- Primary completion16 Oct 2025
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to either routine prostate biopsy plus hypnotic communication or routine prostate biopsy alone. Stratified randomization will account for age, prostate volume, PSA value, lesion site, biopsy approach (transrectal/transperineal), and previous biopsy history.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Fidone, Principal investigator, FPO-IRCCS Cancer Institute of Candiolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476547
- Sponsor's protocol ID
- 004-FPO25
- Acronym
- HYCapp
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of HYpnotic Communication On Anxiety, Pain And Perception Of Care On Patients Undergoing Prostatic Biopsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07476547
- Acronym / sponsor ID
- HYCapp / 004-FPO25
- Keywords
- Prostate biopsy, Hypnotic communication, Procedural anxiety, Procedural pain, Patient experience, Patient satisfaction, anxiety management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 17 Mar 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.
This single-centre randomized controlled study (HYCapp) will evaluate whether "hypnotic communication" (a structured, non-drug communication technique delivered by health professionals trained in clinical hypnosis) can reduce anxiety and pain and improve the overall care experience in patients undergoing outpatient prostate biopsy.
Participants (adults aged 40 years or older scheduled for prostate biopsy at IRCCS Candiolo) will be randomly assigned 1:1 to:
Intervention group: standard prostate biopsy plus hypnotic communication provided by a trained nurse throughout the patient's pathway on the day of the procedure.
Control group: standard prostate biopsy without hypnotic communication. Local anaesthesia may be used in both groups if clinically needed. The main outcomes are patient-reported anxiety (VAS-A), pain (VAS), and satisfaction with the care experience (Likert scale 1-5), together with vital signs (heart rate and blood pressure). Assessments will be collected before the biopsy while waiting (T0) and within 30 minutes after the biopsy (T1). Additional outcomes include use of analgesic and local anaesthetic drugs, perceived versus actual procedure duration, procedure-related complications (e.g., bleeding, vasovagal reaction, fever), and time to return to usual daily/work activities.
Follow-up will include a telephone call 24-36 hours after the biopsy (T2), a questionnaire completed at home 7 days after the procedure (T3), and a further questionnaire at the visit when the histology result is communicated (approximately 20-30 days after the biopsy, T4).
The study plans to enroll 98 participants over about 1 year. Hypnotic communication is not expected to cause physical health risks; all participants will receive standard clinical care for prostate biopsy.
Detailed description
HYCapp is a prospective, single-centre, randomized controlled trial evaluating whether hypnotic communication-a structured, non-pharmacological communication approach delivered by a nurse trained in clinical hypnosis-can improve the peri-procedural experience of adults undergoing outpatient prostate biopsy.
Prostate biopsy is commonly associated with distress and discomfort, even when standard analgesia and local anaesthesia are available. Anxiety may amplify pain perception and worsen the overall experience of care. Hypnotic techniques have shown benefit in other procedural settings by supporting focused attention, reducing anticipatory stress, and promoting coping strategies. This trial aims to generate pragmatic evidence in a real-world urology outpatient pathway.
Participants scheduled for prostate biopsy at IRCCS Candiolo are randomized 1:1 to:
- Standard-of-care biopsy plus hypnotic communication, or
- Standard-of-care biopsy alone. Randomization is performed using a predefined allocation scheme and stratified to balance factors that may influence the patient experience and procedural characteristics (e.g., age, prostate volume, PSA, lesion site, biopsy approach, and previous biopsy history). Due to the nature of the intervention, blinding is not feasible.
Biopsy is performed according to routine practice and guideline-based standards (systematic sampling and/or targeted sampling when clinically indicated). The biopsy approach (transrectal or transperineal) and use of local anaesthesia/analgesics are decided by the clinical team and may occur in both groups.
The operational difference between groups concerns patient support and communication during the procedure:
In the intervention arm, a nurse trained in clinical hypnosis provides hypnotic communication throughout the care pathway on the day of biopsy (arrival, preparation, procedure, and immediate observation), using structured language and attention/imagery techniques; where appropriate, an anchoring phase may be used to facilitate persistence of wellbeing after the procedure, followed by re-orientation.
In the control arm, monitoring and support are provided as per standard practice by staff without hypnotic communication.
Assessments are collected at standardized timepoints: pre-procedure (baseline anxiety/stress-related measures and vital signs), immediately post-procedure (patient-reported experience measures, vital signs, documentation of medications used, perceived vs actual procedure duration, and immediate events), and during follow-up (24-36 hours by telephone, 7 days by questionnaire, and at the visit when histology results are communicated, approximately 20-30 days after biopsy). Follow-up is conducted by staff not trained as clinical hypnologists.
The planned sample size is 98 participants. Analyses will compare groups on changes over time in patient-reported experience and physiological measures, using appropriate statistical methods based on data distribution and accounting for relevant procedural covariates.
All participants receive standard clinical care. Hypnotic communication is not expected to introduce physical health risks and is intended to improve comfort and perceived quality of care during and after the biopsy. Data are handled according to applicable ethical and privacy requirements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either routine prostate biopsy plus hypnotic communication or routine prostate biopsy alone. Stratified randomization will account for age, prostate volume, PSA value, lesion site, biopsy approach (transrectal/transperineal), and previous biopsy history.
| Arm | Type | Receives |
|---|---|---|
| Hypnotic Communication | Experimental | Behavioral: Hypnotic CommunicationParticipants undergo routine prostate biopsy and receive hypnotic communication throughout the procedure from a nurse trained in clinical hypnosis |
| Routine prostate biopsy alone | Active comparator | Procedure: Routine Prostate BiopsyParticipants undergo routine prostate biopsy according to standard clinical practice without hypnotic communication. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with an indication for outpatient prostate biopsy
- Age > 40 years
- Signed informed consent
Key exclusion criteria (2 listed)
- Cognitive impairment
- Chronic pelvic pain syndrome or known perineal neuralgia
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 |
|---|---|---|
| Hypnotic CommunicationA trained nurse uses hypnotic communication throughout the biopsy procedure to support the patient and influence anxiety, pain perception, and perception of care | Behavioural | Hypnotic Communication |
| Routine Prostate BiopsyRoutine outpatient prostate biopsy performed according to standard practice, using a transrectal or transperineal approach as clinically indicated, with local anaesthesia if required | Procedure or surgery | Routine prostate biopsy alone |
Primary outcome
Anxiety level
Time frame: Before prostate biopsy during the waiting period (T0), within 30 minutes after biopsy (T1), 24 to 36 hours after biopsy (T2), 7 days after biopsy (T3), and at the histology result visit, approximately 20 to 30 days after biopsy (T4).
Anxiety assessed using the Visual Analogue Scale for Anxiety (VAS-A), together with vital parameters including heart rate and blood pressure
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 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Francesca Fidone principal investigator
FPO-IRCCS Cancer Institute of Candiolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic Communication and Routine Prostate Biopsy in people with Anxiety and Pain, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
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 3 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 17 Mar 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 Italy. 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?
Anxiety level (time frame: Before prostate biopsy during the waiting period (T0), within 30 minutes after biopsy (T1), 24 to 36 hours after biopsy (T2), 7 days after biopsy (T3), and at the histology result visit, approximately 20 to 30 days after biopsy (T4).). 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 17 Mar 2026.