NCT04707014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

September 17, 2020

Last Update Submit

January 10, 2021

Conditions

Anesthesia

Keywords

analgesiaanxietypainpaediatric surgerydermatologyHypnosisNervous System Diseases CentralHypnotics and SedativesNervous System DepressantsPhysiological Effects of Drugs

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Pain intensity in older children post-operative

    Immediately post-operative while on recovery unit

  • Pain intensity in younger children post-operative

    Immediately post-operative while on recovery unit

  • Pain intensity in older children after 24 hours

    24 hours after discharge

  • Pain intensity in younger children after 24 hours

    24 hours after discharge

  • Analgesic need

    24 hours after discharge

  • +1 more secondary outcomes

Other Outcomes (1)

  • Degree of satisfaction with the procedure

    24 hours after discharge

Study Arms (2)

Attention-Distraction techniques

PLACEBO COMPARATOR

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

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.

Behavioral: Hypnosis

Interventions

HypnosisBEHAVIORAL

Rapid conversational hypnosis

Also known as: Hypnoanalgesia, Hypnosedation
HIPNOSIS GROUP
Attention-distracting techniquesBEHAVIORAL

i-pad with movies, games and music

Attention-Distraction techniques

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Toledo

Toledo, 45002, Spain

Location

Related Publications (4)

  • 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.

    PMID: 28866891BACKGROUND

  • 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.

    PMID: 26599994BACKGROUND

  • 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.

    PMID: 28632194BACKGROUND

  • 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.

    PMID: 32072099BACKGROUND

MeSH Terms

Conditions

AgnosiaAnxiety DisordersPainCentral Nervous System Diseases

Interventions

HypnosisHypnosis, Anesthetic

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesAnesthesiaAnesthesia and Analgesia

Study Officials

  • Juana Maria PELAEZ PEREZ, PH

    Complejo Hospitalario Toledo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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).
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

September 17, 2020

First Posted

January 13, 2021

Study Start

November 1, 2017

Primary Completion

April 15, 2018

Study Completion

April 30, 2018

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Any document upon reasonable request to the PI.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Up to 1 year after publication
Access Criteria
Justified interest in data. By e-mail to PI

Locations

ES(1)