Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Feasibility of Implementing Yoga and Meditation in the Preoperative Period of Pediatric Idiopathic Scoliosis Surgery, an Exploratory Study

Conditions
-----------------
Juvenile and Adolescent Idiopathic Scoliosis

Intervention / Treatment
-----------------
* Other: Yoga and Mindfulness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 8 to 17 years Female and male gender Planned idiopathic scoliosis surgery Exclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children with surgical indication scoliosis follow the Yoga and Mindfulness protocol before surgery<br>Intervention is a noninvasive approach. The protocol is composed of 5 sessions containing simple yoga postures and meditation audio supports to listen to. | Other: Yoga and Mindfulness<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | During the preoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS-anxiety scores | To evaluate the level of anxiety thanks to Visual Analogue Scale (VAS) The VAS-anxiety is rated from 0 to 10 | 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) | 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 | The day before the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yoga, Meditation, Mindfulness, Anesthesia, Idiopathic Scoliosis Surgery, Anxiety, Children, Pediatric