Vascular Access Site PainHYPNACESSNCT04358094
Conversational Hypnosis for Peripherical Veinous Access (HYPNACESS)
A study testing Conversational hypnosis script and Standard script in people with Vascular Access Site Pain, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia. Hypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vascular Access Site Pain
- What is being tested?
- Conversational hypnosis script and Standard script
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2020to 18 Jan 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Digestive endoscopy procedure under general anesthesia in one of the participating centers
- Patient speaking and understanding French
- Patient affiliated or entitled to a social security scheme
- Patient who received enlightened information about the study and who co-signed, with the investigator, a consent to participate after a minimum period of reflection
Who cannot join
- Patient with deafness
- Patient with cognitive impairment
- Pregnant and / or breastfeeding patient
- Patient with dissociative disorders (contraindication to hypnosis)
- Patient suffering from a pathology which can cause chronic pain
- Patient receiving analgesia or anxiety drug
- Patient under justice, curatorship or tutorship
- Patient deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional Universitaire
Nancy, 54000
Hervé Bouaziz, Pr, 0383851403, h.bouaziz@chru-nancy.fr
About this study
Official title: Analgesia Assessment of Conversational Hypnosis Script During Peripherical Veinous Catheter Set up Versus Standard Script in Operating Room
The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia.
Hypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier.
Read more
The working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access.
The main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. A nurse anesthetist is reading the conversational script or standard script during the procedure. The nurse anesthetist is untrained for hypnosis.
The secondary objective are the level of anxiety, patient satisfaction within the perioperative period (EVAN G questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use.
- Conditions
- Vascular Access Site Pain
- Being tested
- Conversational hypnosis script, Standard script
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversational hypnosis scriptOther
Conversational hypnosis during peripherical veinous catheter set up
Standard scriptOther
Standard script during peripherical veinous catheter set up
| Study group | Role | What they receive |
|---|---|---|
| Conversational hypnosis script | Experimental | Patient who received conversational hypnosis script during peripherical veinous access set up Receives: Other: Conversational hypnosis script |
| Standard script | Other | Patient who received standard script during peripherical veinous access set up Receives: Other: Standard script |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia assessment by digital pain scale
Digital pain scale: it describes the severity of the pain On this scale, "0" represents "no pain" and "10" represents "the worst possible pain"
Measured: immediately after applying the peripherical veinous catheter dressing
Secondary outcomes (4)
Level of anxiety by numerical scale
Digital scale: it describes the severity of the pain On this scale, "0" represents "no anxiety" and "10" represents "the worst possible anxiety"
Measured: before randomization and immediately after peripherical veinous catheter set up
patient satisfaction within the perioperative period (EVAN G questionnaire)
EVAN G questionnaire: Score from 0 to 100
The higher the score, the higher the level of patient satisfaction
Measured: between 4 and 48 hours after the procedure
Heart rate
maximum heart rate
Measured: during the procedure
Nurse anesthetist feeling about using the script after each use by digital scale
Evaluate how nurse anesthetist feels about using the script after each use by digital scale ranging from 0 to 10.
On this scale, "0" represents " uncomfortable" and "10" represents " very comfortable "
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start4 May 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion18 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vascular Access Site PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé Bouaziz, Pr, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358094
- Sponsor's protocol ID
- 2020-A00187-32
- Acronym
- HYPNACESS
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain: a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep;37(6):656-8. doi: 10.1007/BF03006485.
PubMed 2208537Nir Y, Paz A, Sabo E, Potasman I. Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg. 2003 Mar;68(3):341-4.
PubMed 12685642Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
PubMed 21856077Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23. doi: 10.1097/00000542-200506000-00010.
PubMed 15915023
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia Assessment of Conversational Hypnosis Script During Peripherical Veinous Catheter Set up Versus Standard Script in Operating Room
- ClinicalTrials.gov ID
- NCT04358094
- Acronym / sponsor ID
- HYPNACESS / 2020-A00187-32
- Conditions
- Vascular Access Site Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 4 May 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 18 Jan 2021 (estimated)
- First posted
- 22 Apr 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.
The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia.
Hypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier.
The working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access.
The main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. A nurse anesthetist is reading the conversational script or standard script during the procedure. The nurse anesthetist is untrained for hypnosis.
The secondary objective are the level of anxiety, patient satisfaction within the perioperative period (EVAN G questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversational hypnosis script | Experimental | Other: Conversational hypnosis scriptPatient who received conversational hypnosis script during peripherical veinous access set up |
| Standard script | Other | Other: Standard scriptPatient who received standard script during peripherical veinous access set up |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Digestive endoscopy procedure under general anesthesia in one of the participating centers
- Patient speaking and understanding French
- Patient affiliated or entitled to a social security scheme
- Patient who received enlightened information about the study and who co-signed, with the investigator, a consent to participate after a minimum period of reflection
Key exclusion criteria (8 listed)
- Patient with deafness
- Patient with cognitive impairment
- Pregnant and / or breastfeeding patient
- Patient with dissociative disorders (contraindication to hypnosis)
- Patient suffering from a pathology which can cause chronic pain
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 |
|---|---|---|
| Conversational hypnosis scriptConversational hypnosis during peripherical veinous catheter set up | Other | Conversational hypnosis script |
| Standard scriptStandard script during peripherical veinous catheter set up | Other | Standard script |
Primary outcome
Analgesia assessment by digital pain scale
Time frame: immediately after applying the peripherical veinous catheter dressing
Digital pain scale: it describes the severity of the pain On this scale, "0" represents "no pain" and "10" represents "the worst possible pain"
4 secondary outcomes
Level of anxiety by numerical scale
Time frame: before randomization and immediately after peripherical veinous catheter set up
patient satisfaction within the perioperative period (EVAN G questionnaire)
Time frame: between 4 and 48 hours after the procedure
Heart rate
Time frame: during the procedure
Nurse anesthetist feeling about using the script after each use by digital scale
Time frame: immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Background: PubMed 2208537Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain: a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep;37(6):656-8. doi: 10.1007/BF03006485.
- Background: PubMed 12685642Nir Y, Paz A, Sabo E, Potasman I. Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg. 2003 Mar;68(3):341-4.
- Background: PubMed 21856077Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
- Background: PubMed 15915023Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23. doi: 10.1097/00000542-200506000-00010.
- 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.
Hervé Bouaziz, Pr principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversational hypnosis script and Standard script in people with Vascular Access Site Pain, run by Central Hospital, Nancy, France 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 4 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: status not confirmed, as of the sponsor's last update on 22 Apr 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hervé Bouaziz, Pr (0383851403, h.bouaziz@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia assessment by digital pain scale (time frame: immediately after applying the peripherical veinous catheter dressing). 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 NCT04358094, which also lists 4 linked publications.
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 22 Apr 2020.