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AnesthesiaNCT04707014

Hypnoanalgesia for Dermatological Surgery in Children

A study testing Hypnosis and Attention-distracting techniques in people with Anesthesia, run by Complejo Hospitalario de Toledo at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 16 years
Conditions the study is for
Anesthesia
What is being tested?
Hypnosis and Attention-distracting techniques
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteSpain
Study dates
1 Nov 2017to 30 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Complejo Hospitalario Toledo

    Toledo, 45002

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
Anesthesia
Being tested
Hypnosis, Attention-distracting techniques
Keywords
analgesia, anxiety, pain, paediatric surgery, dermatology, Hypnosis, Nervous System Diseases Central, Hypnotics and Sedatives, Nervous System Depressants, Physiological Effects of Drugs
Medical subject headings
Agnosia, Anxiety Disorders, Pain, Central Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypnosisBehavioural

    Also called Hypnoanalgesia, Hypnosedation

    Rapid conversational hypnosis

  • Attention-distracting techniquesBehavioural

    i-pad with movies, games and music

Study groups in NCT04707014
Study groupRoleWhat they receive
Attention-Distraction techniquesPlacebo comparatorA 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.
Receives: Behavioral: Attention-distracting techniques
HIPNOSIS GROUPExperimentalA 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.
Receives: Behavioral: Hypnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total dose of propofol in mg/kg

    Measured in mg/kg weight

    Measured: During surgery (Intra-operative)

  2. Total dose of propofol in mg

    Measured in total mg

    Measured: During surgery (Intra-operative)

  3. Additional need for opioids during surgery

    Yes/no

    Measured: During surgery (Intra-operative)

Secondary outcomes (6)

  1. 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

    Measured: Immediately post-operative while on recovery unit

  2. 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

    Measured: Immediately post-operative while on recovery unit

  3. 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

    Measured: 24 hours after discharge

  4. 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

    Measured: 24 hours after discharge

  5. Analgesic need

    Recorded by a blinded nurse at reanimation unit as yes/no

    Measured: 24 hours after discharge

  6. Analgesic needs

    Recorded by a blinded nurse by telephone call as yes/no

    Measured: 24 hours after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start1 Nov 2017
  3. Primary completion15 Apr 2018
  4. Study completion30 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04707014
Sponsor's protocol ID
CHT00028
Status last verified
Jan 2021
First submitted
17 Sep 2020
Last updated
13 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Any document upon reasonable request to the PI.

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.

    PubMed 28866891

  • 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.

    PubMed 26599994

  • 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.

    PubMed 28632194

  • 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.

    PubMed 32072099

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis and Attention-distracting techniques in people with Anesthesia, run by Complejo Hospitalario de Toledo at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total dose of propofol in mg/kg (time frame: During surgery (Intra-operative)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04707014, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.

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