Hypnoanalgesia for Dermatological Surgery in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Behavioral: Attention-distracting techniques; Behavioral: Hypnosis

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45002
    • Complejo Hospitalario Toledo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Attention-Distraction techniques; 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; i-pad with movies, games and music
Experimental: HIPNOSIS GROUP; 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; Rapid conversational hypnosis; Other Names: Hypnoanalgesia; Hypnosedation

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Complejo Hospitalario de Toledo
• Investigators: Principal Investigator: Juana Maria PELAEZ PEREZ, PH, Complejo Hospitalario Toledo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): April 15, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: January 10, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 10, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: pain; dermatology; Hypnosis; anxiety; analgesia; Physiological Effects of Drugs; Hypnotics and Sedatives; paediatric surgery; Nervous System Diseases Central; Nervous System Depressants
• Other Study ID Numbers: CHT00028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Any document upon reasonable request to the PI.
• IPD Sharing Time Frame: Up to 1 year after publication
• IPD Sharing Access Criteria: Justified interest in data. By e-mail to PI
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No