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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention-Distraction techniques | Placebo Comparator | A high-tech distraction technique (AppleĀ®), 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. |
|
| HIPNOSIS GROUP | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis | Behavioral | Rapid conversational hypnosis |
|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of satisfaction with the procedure | Validated survey with score 1-10 administered at the time of discharge to children and their guardians. | 24 hours after discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juana Maria PELAEZ PEREZ, PH | Complejo Hospitalario Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Toledo | Toledo | 45002 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28866891 | Background | Friedrichsdorf SJ, Kohen DP. Integration of hypnosis into pediatric palliative care. Ann Palliat Med. 2018 Jan;7(1):136-150. doi: 10.21037/apm.2017.05.02. Epub 2017 Jun 27. | |
| 26599994 | Background | Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405. |
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Any document upon reasonable request to the PI.
Up to 1 year after publication
Justified interest in data. By e-mail to PI
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: HYPNOANALGESIA IN PEDIATRIC DERMATOLOGICAL SURGERY | Mar 15, 2019 | Jan 6, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: STATISTICAL ANALYSIS | Mar 15, 2019 | Jan 6, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2019 | Jan 8, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D006991 | Hypnosis, Anesthetic |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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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 (AppleĀ®), 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.
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Different investigators are assigned to each phase of the study, with one designated as responsible for recruitment (MQD), another for intervention and control (JMPP), and another for subsequent evaluation in the post-anaesthesia recovery unit (URPA) and at 24 hours (responsible nursing staff).
| Attention-distracting techniques | Behavioral | i-pad with movies, games and music |
|
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 |
| 28632194 | Background | Brown ML, Rojas E, Gouda S. A Mind-Body Approach to Pediatric Pain Management. Children (Basel). 2017 Jun 20;4(6):50. doi: 10.3390/children4060050. |
| 32072099 | Background | Friedrichsdorf SJ, Goubert L. Pediatric pain treatment and prevention for hospitalized children. Pain Rep. 2019 Dec 19;5(1):e804. doi: 10.1097/PR9.0000000000000804. eCollection 2020 Jan-Feb. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D004191 |
| Behavioral Disciplines and Activities |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |