Hypnoanalgesia for Dermatological Surgery in Children

• ClinicalTrials.gov Identifier: NCT04707014
• Recruitment Status: Completed
• First Posted: January 13, 2021
• Last Update Posted: January 13, 2021
• Sponsor: Complejo Hospitalario de Toledo
• Information provided by (Responsible Party): JUANA MARIA PELAEZ PEREZ, Complejo Hospitalario de Toledo

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia	Behavioral: Hypnosis; Behavioral: Attention-distracting techniques	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention 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 (Outcomes Assessor)
• Masking Description: 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).
• Primary Purpose: Other
• Official Title: Effectiveness of Hypnoanalgesia for Dermatological Surgery in Children: Randomised Clinical Trial
• Actual Study Start Date: November 1, 2017
• Actual Primary Completion Date: April 15, 2018
• Actual Study Completion Date: April 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Total dose of propofol in mg/kg [ Time Frame: During surgery (Intra-operative) ]
   Measured in mg/kg weight
2. Total dose of propofol in mg [ Time Frame: During surgery (Intra-operative) ]
   Measured in total mg
3. Additional need for opioids during surgery [ Time Frame: During surgery (Intra-operative) ]
   Yes/no

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Degree of satisfaction with the procedure [ Time Frame: 24 hours after discharge ]
   Validated survey with score 1-10 administered at the time of discharge to children and their guardians.

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

Spain

Complejo Hospitalario Toledo

Toledo, Spain, 45002

Sponsors and Collaborators

Complejo Hospitalario de Toledo

Investigators

• Principal Investigator: Juana Maria PELAEZ PEREZ, PH; Complejo Hospitalario Toledo

  Study Documents (Full-Text)

Documents provided by JUANA MARIA PELAEZ PEREZ, Complejo Hospitalario de Toledo:

Study Protocol: HYPNOANALGESIA IN PEDIATRIC DERMATOLOGICAL SURGERY  [PDF] March 15, 2019

Statistical Analysis Plan: STATISTICAL ANALYSIS  [PDF] March 15, 2019

Informed Consent Form  [PDF] March 15, 2019

More Information

Publications:

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. Review.

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. Review.

Brown ML, Rojas E, Gouda S. A Mind-Body Approach to Pediatric Pain Management. Children (Basel). 2017 Jun 20;4(6). pii: E50. doi: 10.3390/children4060050. Review.

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.

• Responsible Party: JUANA MARIA PELAEZ PEREZ, Anesthesiologist, Complejo Hospitalario de Toledo
• ClinicalTrials.gov Identifier: NCT04707014
• Other Study ID Numbers: CHT00028
• First Posted: January 13, 2021
• Last Update Posted: January 13, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by JUANA MARIA PELAEZ PEREZ, Complejo Hospitalario de Toledo:

analgesia; anxiety; pain; paediatric surgery; dermatology; Hypnosis; Nervous System Diseases Central; Hypnotics and Sedatives; Nervous System Depressants; Physiological Effects of Drugs