Hypnoanalgesia for Dermatological Surgery in Children

Complejo Hospitalario de Toledo

Status: Completed

Conditions: Anesthesia

Treatments: Behavioral: Attention-distracting techniques; Behavioral: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04707014

CHT00028

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A class I or II of anaesthetic risk according to the American Society of Anesthesiologists,
2. to be in a percentile between P3 and P97 in weight and height,
3. without known drug allergies, and
4. having fasted 6 hours for solids and 2 hours for water.

Exclusion criteria

1. Children with diagnosed mental retardation or attention deficit,
2. behavioural disorders,
3. previous treatment with hypnosis,
4. history of neurological pathology or psychomotor retardation,
5. previous pain-related pathology,
6. obstructive sleep apnoea syndrome (OSAS)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups, including a placebo group

Attention-Distraction techniques

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Attention-distracting techniques

HIPNOSIS GROUP

Experimental group

Description:

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.

Treatment:

Behavioral: Hypnosis