Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSEP, relaxation session.
- Who it may be relevant to
- Registry conditions: Relaxation, Somatosensory Evoked Potentials, Patient Experience. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized, Single-blind Study Evaluating the Interest of Prior Relaxation on the Quality of the Recordings of the SomatoSensory Evoked Potentials
Overview
Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation. The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination. The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience
Interventions
- Other SSEP
Every patient presenting for a SSEP will be offered to participate to the study. If accepted, a randomization will determine whether the examination will be preceded by a relaxation session (Relax Group) or not (control group) - Other relaxation session
The relaxation session will be performed by one of the 5 nurses trained in relaxation
Primary outcome measures
- Variation of average rate of automatized artifacts rejection between both groups [Time frame: 19 months]
Eligibility criteria
Inclusion criteria
- Any patient addressed for a study of the somatosensory evoked potentials in upper limbs
- Patients between 18 to 70 years old.
- Patients able to understand the instructions of the relaxation session and the examination.
- Patient providing informed consent exclusion criteria
Exclusion criteria
- No availability of a technician trained in relaxation
- Patient's refusal to participate in the protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Amiens University Hospital — Amiens
Identifiers
NCT: NCT05546307 · PI2019_843_0079