AnaesthesiaKTHYPENCT02662322
Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE)
A study testing Hypnotic communication, negative connotation communication and neutral connotation communication in people with Anaesthesia, run by Rennes University Hospital at 3 sites in 2 countries.
Trial summary
The purpose of this study is to compare three communications during peripheral intravenous catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Hypnotic communication, negative connotation communication and neutral connotation communication
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Mar 2016to 6 Sep 2017
- 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
- at least 18 years
- peripheral intravenous catheterization of 20 G on the dorsal face of the hand before a planned surgery
- written and informed patient consent
- Non inclusion Criteria:
- patient unable to communicate in french
- difficult vein access characteristics
Show all 9Show fewer
- premedication
- pregnant, breast-feeding woman
- patient subject of legal protection
Who cannot join
- failed of the first attempt of peripheral intravenous catheterization
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
CHU
Rennes, 35033
Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, 35768
About this study
Official title: Effect of Language and Confusion on Pain During Peripheral Intravenous
The purpose of this study is to compare three communications during peripheral intravenous catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).
Read the detailed description
Clinicians used to warn patients of pain or discomfort before potentially painful procedures like peripherical intravenous catheterization (PIVC). However, suggestions for negative perceptual experiences causes more pain and anxiety. During This does not improve at all the real-life experience of the act. On the contrary, the use of gentler words improves pain perception and subjective patient experience. Furthermore, hypnosis has been demonstrated as efficient and the pain perception seems to be modulate by hypnotic suggestions.
- Conditions
- Anaesthesia
- Being tested
- Hypnotic communication, negative connotation communication, neutral connotation communication, peripheral intravenous catheterization
- Keywords
- Communication, Confusion, Intravenous Catheterization, Comfort
- Medical subject headings
- Communication, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic communicationOther
hypnotic communication during peripheral intravenous catheterization
negative connotation communicationOther
negative connotation communication during peripheral intravenous catheterization
neutral connotation communicationOther
neutral connotation communication during peripheral intravenous catheterization
peripheral intravenous catheterizationOther
peripheral intravenous catheterization
| Study group | Role | What they receive |
|---|---|---|
| HYPNOSIS | Experimental | hypnotic communication, confusion procedure during peripheral intravenous catheterization Receives: Other: Hypnotic communication; Other: peripheral intravenous catheterization |
| NOCEBO | Active comparator | negative connotation communication during peripheral intravenous catheterization Receives: Other: negative connotation communication; Other: peripheral intravenous catheterization |
| NEUTRAL | Placebo comparator | neutral connotation communication during peripheral intravenous catheterization Receives: Other: neutral connotation communication; Other: peripheral intravenous catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale for pain from 0 to 10
self-evaluation of pain catheterization
Measured: data collected within 3 min after the end of peripheral intravenous catheterization procedure
Secondary outcomes (4)
evolution of numerical rating scale for comfort from 0 to 10
self-evaluation of comfort catheterization
Measured: data collected just before and within 3 min after peripheral intravenous catheterization procedure
evolution of numerical rating scale for anxiety from 0 to 10
self-evaluation of anxiety catheterization
Measured: data collected just before and within 3 min after peripheral intravenous catheterization procedure
presence of spontaneous patient arm withdrawal
Measured: data collected within 3 min after the end of peripheral intravenous catheterization procedure
presence of unprompted vocalization by word(s) or sound(s)
Measured: data collected within 3 min after the end of peripheral intravenous catheterization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start10 Mar 2016
- Primary completion6 Mar 2017
- Study completion6 Sep 2017
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 AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Beloeil, PH, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662322
- Sponsor's protocol ID
- 35RC15_9868
- Acronym
- KTHYPE
- Status last verified
- May 2018
- First submitted
- 12 Jan 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fusco N, Bernard F, Roelants F, Watremez C, Musellec H, Laviolle B, Beloeil H; Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE) group. Hypnosis and communication reduce pain and anxiety in peripheral intravenous cannulation: Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE), a multicentre randomised trial. Br J Anaesth. 2020 Mar;124(3):292-298. doi: 10.1016/j.bja.2019.11.020. Epub 2019 Dec 18.
PubMed 31862159
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Language and Confusion on Pain During Peripheral Intravenous
- ClinicalTrials.gov ID
- NCT02662322
- Acronym / sponsor ID
- KTHYPE / 35RC15_9868
- Conditions
- Anaesthesia
- Keywords
- Communication, Confusion, Intravenous Catheterization, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 25 Jan 2016 (estimated)
- 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 purpose of this study is to compare three communications during peripheral intravenous catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).
Detailed description
Clinicians used to warn patients of pain or discomfort before potentially painful procedures like peripherical intravenous catheterization (PIVC). However, suggestions for negative perceptual experiences causes more pain and anxiety. During This does not improve at all the real-life experience of the act. On the contrary, the use of gentler words improves pain perception and subjective patient experience. Furthermore, hypnosis has been demonstrated as efficient and the pain perception seems to be modulate by hypnotic suggestions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HYPNOSIS | Experimental | Other: Hypnotic communication, Other: peripheral intravenous catheterizationhypnotic communication, confusion procedure during peripheral intravenous catheterization |
| NOCEBO | Active comparator | Other: negative connotation communication, Other: peripheral intravenous catheterizationnegative connotation communication during peripheral intravenous catheterization |
| NEUTRAL | Placebo comparator | Other: neutral connotation communication, Other: peripheral intravenous catheterizationneutral connotation communication during peripheral intravenous catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- at least 18 years
- peripheral intravenous catheterization of 20 G on the dorsal face of the hand before a planned surgery
- written and informed patient consent
- patient unable to communicate in french
- difficult vein access characteristics
Key exclusion criteria (1 listed)
- failed of the first attempt of peripheral intravenous catheterization
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 communicationhypnotic communication during peripheral intravenous catheterization | Other | HYPNOSIS |
| negative connotation communicationnegative connotation communication during peripheral intravenous catheterization | Other | NOCEBO |
| neutral connotation communicationneutral connotation communication during peripheral intravenous catheterization | Other | NEUTRAL |
| peripheral intravenous catheterizationperipheral intravenous catheterization | Other | HYPNOSIS, NEUTRAL, NOCEBO |
Primary outcome
numerical rating scale for pain from 0 to 10
Time frame: data collected within 3 min after the end of peripheral intravenous catheterization procedure
self-evaluation of pain catheterization
4 secondary outcomes
evolution of numerical rating scale for comfort from 0 to 10
Time frame: data collected just before and within 3 min after peripheral intravenous catheterization procedure
evolution of numerical rating scale for anxiety from 0 to 10
Time frame: data collected just before and within 3 min after peripheral intravenous catheterization procedure
presence of spontaneous patient arm withdrawal
Time frame: data collected within 3 min after the end of peripheral intravenous catheterization procedure
presence of unprompted vocalization by word(s) or sound(s)
Time frame: data collected within 3 min after the end of peripheral intravenous catheterization procedure
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 7 May 2018.
- Derived from this study: PubMed 31862159Fusco N, Bernard F, Roelants F, Watremez C, Musellec H, Laviolle B, Beloeil H; Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE) group. Hypnosis and communication reduce pain and anxiety in peripheral intravenous cannulation: Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE), a multicentre randomised trial. Br J Anaesth. 2020 Mar;124(3):292-298. doi: 10.1016/j.bja.2019.11.020. Epub 2019 Dec 18.
- 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.
Helene Beloeil, PH principal investigator
Rennes University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic communication, negative connotation communication and neutral connotation communication in people with Anaesthesia, run by Rennes University Hospital at 3 sites in 2 countries.
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 9 inclusion and 1 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Belgium. 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. Some participants in this study may receive a placebo. 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?
numerical rating scale for pain from 0 to 10 (time frame: data collected within 3 min after the end of peripheral intravenous catheterization procedure). 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 NCT02662322, 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 7 May 2018.