Flutter, AtrialPAINLESSNCT03250871
Hypnosis in Interventional Electrophysiology
A study testing Hypnosis in people with Flutter, Atrial and Over 18 Years Old, run by Poitiers University Hospital at 1 site in France.
Trial summary
Hypnosis has already shown to decrease pain and anxiety in different surgical specialities. Nevertheless, its input has never been studied in cardiology. This research is a prospective, monocentric, controlled and randomized study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flutter, Atrial, Over 18 Years Old
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2017to 26 Sep 2019
- 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
- Over 18 years old
- Surgery ablation of atrial flutter
- Agreement to participate of the study
Who cannot join
- Person who does not speak French or deaf
- Chronic pain with the visual analogue scale > 5
- Psychiatric pathology
- Contraindication to paracetamol, lidocaine, morphine
- Pregnant women, or breast-feeding women or without effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?
Hypnosis has already shown to decrease pain and anxiety in different surgical specialities. Nevertheless, its input has never been studied in cardiology. This research is a prospective, monocentric, controlled and randomized study.
Patients over 18 years old and hospitalized for atrial flutter ablation may be included and randomized into one of the arms: placebo or hypnosis.
Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption, and patient sedation will also be assessed.
The aim of this study is to improve the care given to patient undergoing atrial flutter ablation.
- Conditions
- Flutter, Atrial, Over 18 Years Old
- Being tested
- Hypnosis, Placebo
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
PlaceboOther
Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo will be the suggestion of self-relaxation methods (for example, "try to relax" ,"try to think of pleasant moment ") and the diffusion of "white noise" during surgery. Receives: Other: Placebo |
| Hypnosis | Experimental | Hypnosis will be associated with the usual anesthesia. Hypnosis is a temporary modification of consciousness technique based on suggestion.
It is divided into three phases:
* induction: attention of the patient fixed on an object or a part of the body,
* the dissociation where the patient cuts off auditory, visual and tactile perceptions,
* and finally the opening towards a hypnotic experience thanks to the imaginary. Receives: Other: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global pain self-assessment during the procedure
Assessed with visual analogue pain scale
Measured: Collected 45 min after the procedure
Secondary outcomes (4)
Anxiety during the procedure
Visual analog scale self-assessment
Measured: Collected after the procedure
Morphine consumption
milligram
Measured: Collected after the procedure
Patient sedation evaluation
numerical rating scale; Externally assessed by the electrophysiologist
Measured: Collected after the procedure
Pain assessed prospectively during the procedure;
Numerical rating scale score
Measured: Evaluated every 5 minutes during the procedure;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start2 Oct 2017
- Primary completion23 Sep 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flutter, AtrialStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250871
- Sponsor's protocol ID
- 2017-A01936-47
- Acronym
- PAINLESS
- Status last verified
- Dec 2019
- First submitted
- 11 Aug 2017
- Last updated
- 10 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?
- ClinicalTrials.gov ID
- NCT03250871
- Acronym / sponsor ID
- PAINLESS / 2017-A01936-47
- Conditions
- Flutter, Atrial, Over 18 Years Old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 16 Aug 2017 (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.
Hypnosis has already shown to decrease pain and anxiety in different surgical specialities. Nevertheless, its input has never been studied in cardiology. This research is a prospective, monocentric, controlled and randomized study.
Patients over 18 years old and hospitalized for atrial flutter ablation may be included and randomized into one of the arms: placebo or hypnosis.
Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption, and patient sedation will also be assessed.
The aim of this study is to improve the care given to patient undergoing atrial flutter ablation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be the suggestion of self-relaxation methods (for example, "try to relax" ,"try to think of pleasant moment ") and the diffusion of "white noise" during surgery. |
| Hypnosis | Experimental | Other: HypnosisHypnosis will be associated with the usual anesthesia. Hypnosis is a temporary modification of consciousness technique based on suggestion. It is divided into three phases: * induction: attention of the patient fixed on an object or a part of the body, * the dissociation where the patient cuts off auditory, visual and tactile perceptions, * and finally the opening towards a hypnotic experience thanks to the imaginary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Surgery ablation of atrial flutter
- Agreement to participate of the study
Key exclusion criteria (5 listed)
- Person who does not speak French or deaf
- Chronic pain with the visual analogue scale > 5
- Psychiatric pathology
- Contraindication to paracetamol, lidocaine, morphine
- Pregnant women, or breast-feeding women or without effective contraception
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 |
|---|---|---|
| HypnosisHypnosis will be supervised by a nurse trained by the French Institute of Hypnosis. | Other | Hypnosis |
| PlaceboPlacebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones | Other | Placebo |
Primary outcome
Global pain self-assessment during the procedure
Time frame: Collected 45 min after the procedure
Assessed with visual analogue pain scale
4 secondary outcomes
Anxiety during the procedure
Time frame: Collected after the procedure
Morphine consumption
Time frame: Collected after the procedure
Patient sedation evaluation
Time frame: Collected after the procedure
Pain assessed prospectively during the procedure;
Time frame: Evaluated every 5 minutes during the 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 10 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Flutter, Atrial and Over 18 Years Old, run by Poitiers University Hospital 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 3 inclusion and 5 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 10 Feb 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. 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?
Global pain self-assessment during the procedure (time frame: Collected 45 min after the procedure). 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 10 Feb 2020.