Hypnoanalgesia for Dermatological Surgery in Children

Study Overview
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Brief Summary
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This randomized clinical trial will evaluate the effect of hypnosedation on the need of sedation and analgesia in a pediatric population undergoing dermatological surgery, both during the procedure, and 24 hours after surgery. In addition, a secondary objetive is to evaluate the effect by specific age groups.

Detailed Description
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In this clinical trial, pediatric patients scheduled for removal of benign skin lesions in a single center willbe randomised to receive hypnosis (intervention group) or attention-distracting techniques (control group). Endpoints will be the sedative dose (propofol) during surgery, and the need for analgesia (paracetamol and others) immediately after surgery (recovery) and after 24 hours. Randomization will be systematic in blocks depending on the day the surgery is programmed. Hypnosis will be delivered by an experienced anesthesist trained in the technique. Patients and families will be informed of the special treatment during surgery, but will be unaware of whether the patients are experiencing distraction or hypnosis techniques. Distraction is already a useful technique, and it is expected that patients will be satisfied with the procedure; however, the hypothesis to be tested is that hypnosis reduces the need for sedation and analgesia compared to distraction techniques, as well as improves satisfaction.

Official Title
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Effectiveness of Hypnoanalgesia for Dermatological Surgery in Children: Randomised Clinical Trial

Conditions
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Anesthesia

Intervention / Treatment
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* Behavioral: Hypnosis
* Behavioral: Attention-distracting techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A class I or II of anaesthetic risk according to the American Society of Anesthesiologists, to be in a percentile between P3 and P97 in weight and height, without known drug allergies, and having fasted 6 hours for solids and 2 hours for water. Exclusion Criteria: Children with diagnosed mental retardation or attention deficit, behavioural disorders, previous treatment with hypnosis, history of neurological pathology or psychomotor retardation, previous pain-related pathology, obstructive sleep apnoea syndrome (OSAS)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomly distributed to one of the following groups: Intervention group: Technique of rapid conversational hypnosis, with focus on therapeutic suggestion (guiding the patient into a hypnotic trance), adapted to child's cognitive development. Induction with hypnotic suggestion focuses and accompanies the child's body sensations and allows their active participation. After standard sedation, therapeutic suggestion is maintained throughout the surgery and in the post-hypnotic period before awakening. Control group: High-tech distraction technique (Apple®), passive and chosen by the child, either an animated video or his or her favourite music. After standard intravenous sedation, the child is taken to the operating theatre to watch his or her favourite video or music and this is maintained throughout the procedure.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Attention-Distraction techniques<br>A high-tech distraction technique (Apple®), passive and chosen by the child, either an animated video or his or her favourite music. After standard intravenous sedation, the child is taken to the operating theatre to watch his or her favourite video or music and this is maintained throughout the procedure. | Behavioral: Attention-distracting techniques<br>* i-pad with movies, games and music<br>|
| Experimental: HIPNOSIS GROUP<br>A technique of rapid conversational hypnosis, with focus on therapeutic suggestion (guiding the patient into a hypnotic trance), adapted to the child's cognitive development. Induction with hypnotic suggestion focuses and accompanies the child's body sensations and allows their active participation. After standard sedation, therapeutic suggestion is maintained throughout the surgery and in the post-hypnotic period before awakening. | Behavioral: Hypnosis<br>* Rapid conversational hypnosis<br>* Other names: Hypnosedation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of propofol in mg/kg | Measured in mg/kg weight | During surgery (Intra-operative) | 
| Total dose of propofol in mg | Measured in total mg | During surgery (Intra-operative) | 
| Additional need for opioids during surgery | Yes/no | During surgery (Intra-operative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity in older children post-operative | 0-10 visual analogue scale (VAS) administered by a blinded nurse, with higher values indicating higher levels of pain | Immediately post-operative while on recovery unit | 
| Pain intensity in younger children post-operative | 0-10 Faces Pain Scale - Revised (FPS-r) administered by a blinded nurse, with higher values indicating higher levels of pain | Immediately post-operative while on recovery unit | 
| Pain intensity in older children after 24 hours | 0-10 visual analogue scale (VAS) administered over the phone by a blinded nurse, with higher values indicating higher levels of pain | 24 hours after discharge | 
| Pain intensity in younger children after 24 hours | 0-10 Faces Pain Scale - Revised (FPS-r) administered over the phone by a blinded nurse, with higher values indicating higher levels of pain | 24 hours after discharge | 
| Analgesic need | Recorded by a blinded nurse at reanimation unit as yes/no | 24 hours after discharge | 
| Analgesic needs | Recorded by a blinded nurse by telephone call as yes/no | 24 hours after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, anxiety, pain, paediatric surgery, dermatology, Hypnosis, Nervous System Diseases Central, Hypnotics and Sedatives, Nervous System Depressants, Physiological Effects of Drugs