Juvenile and Adolescent Idiopathic ScoliosisYOMEPOPNCT05805670
Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery
A study testing Yoga and Mindfulness in people with Juvenile and Adolescent Idiopathic Scoliosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study has to purpose Yoga and Meditation before surgery for idiopathic scoliosis. Protocol's observance will tell the investigators if it is feasible and appropriate in a University hospital center. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Juvenile and Adolescent Idiopathic Scoliosis
- What is being tested?
- Yoga and Mindfulness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2023to 16 Mar 2024
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 8 to 17 years
- Female and male gender
- Planned idiopathic scoliosis surgery
Who cannot join
- Physical inability to do simple yoga postures during the initial session
- Neurological spinal deformity (cerebral palsy, severe epileptic disease, myopathy)
- Misunderstanding of the french language
- Recent history of characterized depressive episode: hospitalization and/or antidepressant treatment in the last 6 months
- Time between the first YOMEPOP session and the date of the operation less than 28 days
- Refusal of permission to take picture
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- Failure to obtain informed consent from one of the parents with parental authority
- Absence of affiliation to a French social security scheme or beneficiary of such a scheme
- Patient with a legal protection measure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Implementing Yoga and Meditation in the Preoperative Period of Pediatric Idiopathic Scoliosis Surgery, an Exploratory Study
This study has to purpose Yoga and Meditation before surgery for idiopathic scoliosis.
Protocol's observance will tell the investigators if it is feasible and appropriate in a University hospital center.
Read the detailed description
Adolescent idiopathic scoliosis is the most common deforming orthopedic condition.
Preoperative anxiety is increased by operating time, post-operative pain level, neurological and hemorrhagic risk.
The aim of the study was to purpose five sessions of Yoga and Meditation before surgery, remotely and face-to-face.
Observance of the 5 sessions will tell us if this protocol is feasible and appropriate. Preoperative anxiety intensity will also be analyzed.
- Being tested
- Yoga and Mindfulness
- Keywords
- Yoga, Meditation, Mindfulness, Anesthesia, Idiopathic Scoliosis Surgery, Anxiety, Children, Pediatric
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga and MindfulnessOther
Intervention is a noninvasive approach. The protocol is composed of 5 sessions containing simple yoga postures and meditation audio supports to listen to and 1 post-operative visit (24 hours after surgery)
The 5 sessions will be carried out 1 session/week from inclusion to the day before surgery
| Study group | Role | What they receive |
|---|---|---|
| Children with surgical indication scoliosis follow the Yoga and Mindfulness protocol before surgery | Experimental | Intervention is a noninvasive approach. The protocol is composed of 5 sessions containing simple yoga postures and meditation audio supports to listen to. Receives: Other: Yoga and Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with observance greater than or equal to 2
Yoga and Meditation protocol's observance will be rated from 0 to 3 (0 is a session not completed to 3 is a fully completed session)
Measured: During the preoperative period
Secondary outcomes (3)
VAS-anxiety scores
To evaluate the level of anxiety thanks to Visual Analogue Scale (VAS) The VAS-anxiety is rated from 0 to 10
Measured: From preoperative period up to 1 day postoperative
FPS-R scores
To evaluate the level of pain thanks to Face Pain Scale-Revised (FPS-R) The FPS-R scale is rated from 0 to 10 (0 is no pain to 10 extreme pain)
Measured: From preoperative period up to 1 day postoperative
Assessment of satisfaction of Yoga and Meditation protocol
Satisfaction of parents and child will be rated from 1 to 3
- Not satisfied
- Moderately satisfied
- Satisfied
Measured: The day before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start18 Apr 2023
- Primary completion16 Mar 2024
- Study completion16 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile and Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabrielle VEISLINGER, Principal investigator, Hospital of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805670
- Sponsor's protocol ID
- RECHMPL22_0057
- Acronym
- YOMEPOP
- Status last verified
- Apr 2024
- First submitted
- 27 Feb 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing Yoga and Meditation in the Preoperative Period of Pediatric Idiopathic Scoliosis Surgery, an Exploratory Study
- ClinicalTrials.gov ID
- NCT05805670
- Acronym / sponsor ID
- YOMEPOP / RECHMPL22_0057
- Keywords
- Yoga, Meditation, Mindfulness, Anesthesia, Idiopathic Scoliosis Surgery, Anxiety, Children, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 16 Mar 2024 (actual)
- First posted
- 10 Apr 2023 (actual)
- 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 has to purpose Yoga and Meditation before surgery for idiopathic scoliosis.
Protocol's observance will tell the investigators if it is feasible and appropriate in a University hospital center.
Detailed description
Adolescent idiopathic scoliosis is the most common deforming orthopedic condition.
Preoperative anxiety is increased by operating time, post-operative pain level, neurological and hemorrhagic risk.
The aim of the study was to purpose five sessions of Yoga and Meditation before surgery, remotely and face-to-face.
Observance of the 5 sessions will tell us if this protocol is feasible and appropriate. Preoperative anxiety intensity will also be analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with surgical indication scoliosis follow the Yoga and Mindfulness protocol before surgery | Experimental | Other: Yoga and MindfulnessIntervention is a noninvasive approach. The protocol is composed of 5 sessions containing simple yoga postures and meditation audio supports to listen to. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from 8 to 17 years
- Female and male gender
- Planned idiopathic scoliosis surgery
Key exclusion criteria (9 listed)
- Physical inability to do simple yoga postures during the initial session
- Neurological spinal deformity (cerebral palsy, severe epileptic disease, myopathy)
- Misunderstanding of the french language
- Recent history of characterized depressive episode: hospitalization and/or antidepressant treatment in the last 6 months
- Time between the first YOMEPOP session and the date of the operation less than 28 days
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 |
|---|---|---|
| Yoga and MindfulnessIntervention is a noninvasive approach. The protocol is composed of 5 sessions containing simple yoga postures and meditation audio supports to listen to and 1 post-operative visit (24 hours after surgery) The 5 sessions will be carried out 1 session/week from inclusion to the day before surgery | Other | Children with surgical indication scoliosis follow the Yoga and Mindfulness protocol before surgery |
Primary outcome
Percentage of patients with observance greater than or equal to 2
Time frame: During the preoperative period
Yoga and Meditation protocol's observance will be rated from 0 to 3 (0 is a session not completed to 3 is a fully completed session)
3 secondary outcomes
VAS-anxiety scores
Time frame: From preoperative period up to 1 day postoperative
FPS-R scores
Time frame: From preoperative period up to 1 day postoperative
Assessment of satisfaction of Yoga and Meditation protocol
Time frame: The day before the surgery
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 11 Apr 2024.
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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.
Gabrielle VEISLINGER principal investigator
Hospital of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Mindfulness in people with Juvenile and Adolescent Idiopathic Scoliosis, run by University Hospital, Montpellier 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 9 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 11 Apr 2024. 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?
Percentage of patients with observance greater than or equal to 2 (time frame: During the preoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2024.