Osteotomy and Spinal Column SurgeryHYPOPANXNCT01320956
Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years
A study testing Pre operative nurse consultation and Hypnosis and Pre operative nurse consultation in people with Osteotomy and Spinal Column Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years to 215 months
- Conditions the study is for
- Osteotomy and Spinal Column Surgery
- What is being tested?
- Pre operative nurse consultation and Hypnosis and Pre operative nurse consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Mar 2013
- 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 10 years to 215 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 10-18 years
- Orthopaedics surgery (spinal column, osteotomy)
- ASA 1 \& 2
Who cannot join
- casualty surgery
- patient or family unable to understand the study (language, disability ...)
- patient or family refusing the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years
This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.
Read the 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.
- Conditions
- Osteotomy and Spinal Column Surgery
- Being tested
- Pre operative nurse consultation and Hypnosis, Pre operative nurse consultation
- Keywords
- hypnosis, HYPNOANALGESIA, surgery, children, anxiety, morphine, pain, A-VAS, orthopaedics, osteotomy, tenotomy, arthrodesis, spinal column surgery
- Medical subject headings
- Anxiety Disorders, Pain, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre operative nurse consultation and HypnosisBehavioural
Also called Hypnosis, HYPNOANALGESIA
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.
Pre operative nurse consultationOther
Also called Control
Pre operative nurse consultation with pain management nurse. Usual care and anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | Pre operative nurse consultation and Hypnosis:
will have hypnosis Receives: Behavioral: Pre operative nurse consultation and Hypnosis |
| Control | Active comparator | Pre operative nurse consultation:
usual nurse consultation without hypnosis Receives: Other: Pre operative nurse consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anxiety at day 1 (24 hours after surgery)
Level anxiety will be measured 24 hours after exit of operating room, using A-VAS (Anxiety visual analog scale) by a single blind assessor.
Measured: 24 hours
Secondary outcomes (2)
Anxiety level
difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)
Measured: 24 hours
Pain after surgery
need for analgesics (morphine)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteotomy and Spinal Column SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chantal WOOD, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320956
- Sponsor's protocol ID
- P100112
- Other IDs
- 2010-A01165-34
- Acronym
- HYPOPANX
- Status last verified
- Sep 2013
- First submitted
- 21 Mar 2011
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Duparc-Alegria N, Tiberghien K, Abdoul H, Dahmani S, Alberti C, Thiollier AF. Assessment of a short hypnosis in a paediatric operating room in reducing postoperative pain and anxiety: A randomised study. J Clin Nurs. 2018 Jan;27(1-2):86-91. doi: 10.1111/jocn.13848. Epub 2017 Jul 4.
PubMed 28403569
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years
- ClinicalTrials.gov ID
- NCT01320956
- Acronym / sponsor ID
- HYPOPANX / P100112
- Conditions
- Osteotomy and Spinal Column Surgery
- Keywords
- hypnosis, HYPNOANALGESIA, surgery, children, anxiety, morphine, pain, A-VAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Behavioral: Pre operative nurse consultation and HypnosisPre operative nurse consultation and Hypnosis: will have hypnosis |
| Control | Active comparator | Other: Pre operative nurse consultationPre operative nurse consultation: usual nurse consultation without hypnosis |
Who may qualify
- Ages
- 10 years to 215 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 10-18 years
- Orthopaedics surgery (spinal column, osteotomy)
- ASA 1 \& 2
Key exclusion criteria (3 listed)
- casualty surgery
- patient or family unable to understand the study (language, disability ...)
- patient or family refusing the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre operative nurse consultation and HypnosisAlso: Hypnosis, HYPNOANALGESIAPre operative nurse consultation with pain management nurse, the day before surgery and 5 to 10 minutes of hypnosis, just before anesthesia, with trained nurse. | Behavioural | Hypnosis |
| Pre operative nurse consultationAlso: ControlPre operative nurse consultation with pain management nurse. Usual care and anesthesia | Other | Control |
Primary outcome
Level of anxiety at day 1 (24 hours after surgery)
Time frame: 24 hours
Level anxiety will be measured 24 hours after exit of operating room, using A-VAS (Anxiety visual analog scale) by a single blind assessor.
2 secondary outcomes
Anxiety level
Time frame: 24 hours
Pain after surgery
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Results publication: PubMed 28403569Duparc-Alegria N, Tiberghien K, Abdoul H, Dahmani S, Alberti C, Thiollier AF. Assessment of a short hypnosis in a paediatric operating room in reducing postoperative pain and anxiety: A randomised study. J Clin Nurs. 2018 Jan;27(1-2):86-91. doi: 10.1111/jocn.13848. Epub 2017 Jul 4.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal WOOD, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre operative nurse consultation and Hypnosis and Pre operative nurse consultation in people with Osteotomy and Spinal Column Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 3 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 6 Feb 2023. 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 France. 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. 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?
Level of anxiety at day 1 (24 hours after surgery) (time frame: 24 hours). 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 NCT01320956, which also lists 1 linked publication.
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 6 Feb 2023.