Varicose VeinsNCT03601572
Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis
An observational study of Varicose Veins, run by University Hospital, Montpellier.
Trial summary
Endoveinous treatment of saphenous varicoses and phlebectomia of tributary veins are commonly performed under local anesthesia. Hypnoanalgesia might reduce perinterventional pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2018to 1 Oct 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
Who may be able to join
- patients treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
- Age of 18 and over
Who cannot join
- NA
About this study
Endoveinous treatment of saphenous varicoses and phlebectomia of tributary veins are commonly performed under local anesthesia. Hypnoanalgesia might reduce perinterventional pain.
This study has the aim to test the effectiveness of hypnoanalgesia, performed by a specialised nurse, for peri-and post-procedual pain reduction.
- Conditions
- Varicose Veins
- Being tested
- No intervention
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effects of hypnosis
Assessment of the contribution of hypnosis in patients who will be treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
Measured: on intraoperative
Evaluate the effects of hypnosis
Assessment of the contribution of hypnosis in patients who will be treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start2 Sep 2018
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Why it stopped: Abandoned research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GUDRUN BOGE, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601572
- Sponsor's protocol ID
- RECHMPL17_0453
- Status last verified
- Dec 2017
- First submitted
- 11 Jan 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis
- ClinicalTrials.gov ID
- NCT03601572
- Acronym / sponsor ID
- RECHMPL17_0453
- Conditions
- Varicose Veins
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Abandoned research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Sep 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 26 Jul 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.
Endoveinous treatment of saphenous varicoses and phlebectomia of tributary veins are commonly performed under local anesthesia. Hypnoanalgesia might reduce perinterventional pain.
This study has the aim to test the effectiveness of hypnoanalgesia, performed by a specialised nurse, for peri-and post-procedual pain reduction.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
Key inclusion criteria (2 listed)
- patients treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
- Age of 18 and over
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Evaluate the effects of hypnosis
Time frame: on intraoperative
Assessment of the contribution of hypnosis in patients who will be treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
Evaluate the effects of hypnosis
Time frame: 1 day
Assessment of the contribution of hypnosis in patients who will be treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: Undecided. NC
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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.
GUDRUN BOGE principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins, run by University Hospital, Montpellier.
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 2 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: withdrawn, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the effects of hypnosis (time frame: on intraoperative). The study lists 2 primary outcomes in all. 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 15 Oct 2018.