An interventional study of hypnotic guidance in Pain Management, sponsored by University Hospital, Angers. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Supportive care
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.
1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.
This study's planned enrollment of 134 is above the median of 75 across 1,089 interventional studies indexed under Agnosia.
Browse Agnosia studies →University Hospital, Angers is the lead sponsor of 477 studies on the registry; 119 are open to participants now.
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In the experimental arm, the patient will listen to a pre-recorded hypnotic guidance session selected from three options.
Combination Product: hypnotic guidance
The control arm will receive standard care for suturable wounds, including local anesthesia with subcutaneous lidocaine prior to stitching.
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.
The change in pain level between pain assessed before the stitching procedure and the maximum pain experienced during 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.
Time frame: 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 evolution of the patient's comfort level before and during the stitching procedure
The change in the patient's comfort level before and during stitching, assessed using a numerical scale from 0 to 10,
Time frame: Peri-procedural: before and during the suturing procedure.
The evolution of the anxiety level before and after stitching
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
Time frame: Peri-procedural: before and during the suturing procedure.
The subjective experience of the healthcare professional performing the 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.
Time frame: Peri-procedural: before and during the suturing procedure.
No study locations are listed for this record.
Plan to share: Yes — Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Supporting information: Study protocol
Time frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
Access criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Feb 2029, 24 months later.
Of 606 non-industry interventional studies with no phase under Agnosia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 24 months is above that.
Counting every sponsor, half of 615 studies reached it within 12 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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