Hypnosis Antalgia Emergency Stitching

NCT07872891 — Not applicable, Not yet recruiting, 134 participants, University Hospital, Angers

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Evaluation of Hypnotic Guidance Via Audio Headset for Pain Management During Stitching of Wound in the Emergency Department: A Randomized, Multicenter Study.

RegistryNCT07872891, acronym HYPNAUS
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment134 (Estimated)
SponsorUniversity Hospital, Angers (Other gov)
ConditionsPain Management
Interventionshypnotic guidance (Combination product)
Datesstart 2027-02-01 (estimated), primary completion 2029-02-01 (estimated), completion 2029-02-01 (estimated), first posted 2026-10-14, last updated 2026-10-14

Related Papers Related Patents Related Grants Related Experts
All trials for Pain Management All trials of hypnotic guidance

-Summary

Pain is one of the most common reasons patients seek care in emergency departments. Managing pain effectively is an important part of emergency care because it can improve patients' comfort and overall experience. Wounds that require stitches are also a common reason for visiting the emergency department. Stitching a wound can be painful, both because of the original injury and because of the procedure itself, even when local anesthetic is used. Hypnosis is a state of focused attention in which people may become more responsive to suggestions. It is increasingly used as a non-drug approach to managing pain and anxiety, including during medical and surgical procedures. However, hypnosis is still not widely used in emergency departments, mainly because it usually requires trained staff and additional time. One possible solution is to use a pre-recorded hypnosis audio. Instead of a healthcare professional performing hypnosis directly, the patient could listen to a guided recording during the procedure. Previous research suggests that this approach may provide pain relief similar to that achieved with live hypnosis. HYPNAUS is a study comparing the use of local anesthesia via subcutaneous lidocaine injection with hypnotic guidance via headphones combined with local anesthesia via subcutaneous lidocaine injection alone. We hypothesize that patients receiving hypnotic guidance combined with local anesthesia via subcutaneous lidocaine injection will experience less pain during the stitching procedure.

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+Arms and interventions

ArmTypeInterventionsDescription
hypnotic guidanceExperimentalCombination Product: hypnotic guidanceIn the experimental arm, the patient will listen to a pre-recorded hypnotic guidance session selected from three options.
local anesthesia via subcutaneous lidocaine injectionNo interventionThe control arm will receive standard care for suturable wounds, including local anesthesia with subcutaneous lidocaine prior to stitching.
  • hypnotic guidance (Combination product): In the experimental group, patients will listen to a pre-recorded hypnotic guidance session selected from three options. Headphones for the session will be fitted approximately five minutes before the procedure begins. These audio recordings consist of three distinct phases: induction, trance, and termination. Each recording lasts 15 minutes. However, if the procedure takes longer, the post-hypnotic suggestions included in the recording can extend the trance for as long as necessary. The remainder of the patient's care is identical to that of the control group and involves local anesthesia via subcutaneous lidocaine prior to stitching. Patients assigned to the hypnotic guidance arm who do not listen to the entire audio recording will still be analyzed as part of that arm. However, if stitching is finished before the recording ends, it is recommended that you allow it to finish so as not to interfere with the patient's trance termination.

+Outcome measures

Primary outcomes

  • The change in pain level between pain assessed before the stitching procedure and the maximum pain experienced during the procedure. [Peri-procedural: pain experienced before the suturing procedure is assessed immediately before the procedure, and pain experienced during the suturing procedure is assessed immediately after completion of the procedure]: The primary outcome measure is the change in pain intensity-assessed using a 0-10 numerical rating scale (NRS)-from baseline (pain experienced prior to the stitching procedure) to the maximum pain experienced during the procedure. A greater reduction in pain intensity is expected in the hypnotic guidance arm compared with the control arm.

Secondary outcomes

  • The evolution of the patient's comfort level before and during the stitching procedure [Peri-procedural: before and during the suturing procedure.]: The change in the patient's comfort level before and during stitching, assessed using a numerical scale from 0 to 10,
  • The evolution of the anxiety level before and after stitching [Peri-procedural: before and during the suturing procedure.]: Changes in anxiety levels will also be assessed using the State-Trait Anxiety Inventory questionnaire before and after stitching. The minimum values is 20 and maximum values is 80. A higher scores mean worse outcome
  • The subjective experience of the healthcare professional performing the procedure [Peri-procedural: before and during the suturing procedure.]: The healthcare provider's experience is assessed using a specific questionnaire, which is administered after the stitching procedure to best evaluate both their perception of the conditions under which the stitching was performed and their assessment of the patient's comfort. This questionnaire was developed specifically for this study because, to our knowledge, no such questionnaire is available in the literature. It includes data collection items and three questions assessing subjective response levels based on a 4-point Likert scale.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patient aged over 18
* Presenting to the emergency department with a wound requiring a single suture
* Admitted to a participating emergency department
* Affiliated with a social security scheme
* Having provided verbal informed consent to participate in the study

Exclusion Criteria:

* Patient with a prior negative experience with hypnosis
* Patients who have received MEOPA or Penthrox
* Patient with a contraindication to lidocaine (notably an allergy)
* Patient with hearing impairment
* Patient unable to rate their pain using the numerical scale
* Wound requiring stapling
* Scalp or ENT wound preventing the use of headphones
* Patient with poor understanding of the French language
* Pregnant woman, woman in labor, or breastfeeding mother
* Person deprived of liberty by judicial or administrative decision, or subject to a legal protection measure
* Person subject to involuntary psychiatric care or suffering from an unstable psychiatric condition
* Person unable to provide free and informed consent (cognitive impairment, intoxication, etc.)

+Investigators

  • AurĂ©lie FIENI, MD, Principal investigator, University Hospital, Angers