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Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years

Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01320956
Acronym
HYPOPANX
Enrollment
120
Registered
2011-03-23
Start date
2011-03-31
Completion date
2013-03-31
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteotomy and Spinal Column Surgery

Keywords

hypnosis, HYPNOANALGESIA, surgery, children, anxiety, morphine, pain, A-VAS, orthopaedics, osteotomy, tenotomy, arthrodesis, spinal column surgery

Brief summary

This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.

Detailed description

Undergoing surgery can cause anxiety among children. Thus, peri operative anxiety can increase levels of pain, need for painkillers, and even length of stay in hospital. Caring for children must take in account their anxiety. This anxiety can be treated through drugs or others means such as hypnosis. Thus, the use hypnosis in surgery has been very poorly assessed. Parents will be given a consent form as well as an information note. This study aims to compare the level of post operative anxiety (D1)of children having hypnosis before receiving anaesthetics to the level of anxiety of children getting the usual care. All the children included in this study will have a pre operative consultation with the Pain Management Nurse. The study applies to inpatients, aged 10 to 18 years, who must go through orthopaedics surgery such as osteotomy (bone section) and spinal column surgery. 120 patients will be included in this study (60 in each arm) The primary outcome measure is the level of anxiety at day 1 (24 hours after surgery) Other outcome measure are * the difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery) * the use of morphine during the first 24 hours This study is a prospective randomized trial, comparing a usual analgesics procedure to an experimental analgesics procedure including hypnosis before anaesthesia. Expected impact of this study :change in procedures, decrease of anxiety levels in patients by the use of hypnosis before anaesthesia.

Interventions

BEHAVIORALPre operative nurse consultation and Hypnosis

Pre operative nurse consultation with pain management nurse, the day before surgery and 5 to 10 minutes of hypnosis, just before anesthesia, with trained nurse.

OTHERPre operative nurse consultation

Pre operative nurse consultation with pain management nurse. Usual care and anesthesia

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 215 Months
Healthy volunteers
No

Inclusion criteria

* age 10-18 years * Orthopaedics surgery (spinal column, osteotomy) * ASA 1 & 2

Exclusion criteria

* casualty surgery * patient or family unable to understand the study (language, disability ...) * patient or family refusing the study

Design outcomes

Primary

MeasureTime frameDescription
Level of anxiety at day 1 (24 hours after surgery)24 hoursLevel anxiety will be measured 24 hours after exit of operating room, using A-VAS (Anxiety visual analog scale) by a single blind assessor.

Secondary

MeasureTime frameDescription
Anxiety level24 hoursdifference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)
Pain after surgery24 hoursneed for analgesics (morphine)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026