Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery

Not Applicable

Completed

• Conditions: Juvenile and Adolescent Idiopathic Scoliosis
• Interventions: Other: Yoga and Mindfulness

• Registration Number: NCT05805670
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-10
• Study Start: 2023-04-18
• Primary Completion: 2024-03-16
• Study Completion: 2024-03-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with surgical indication scoliosis follow the Yoga and Mindfulness protocol before surgery	Yoga and Mindfulness	Intervention is a noninvasive approach. The protocol is composed of 5 sessions containing simple yoga postures and meditation audio supports to listen to.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with observance greater than or equal to 2	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)

Secondary Outcome Measures

Name	Time	Method
FPS-R scores	From preoperative period up to 1 day postoperative	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)
Assessment of satisfaction of Yoga and Meditation protocol	The day before the surgery	Satisfaction of parents and child will be rated from 1 to 3; 1. Not satisfied; 2. Moderately satisfied; 3. Satisfied
VAS-anxiety scores	From preoperative period up to 1 day postoperative	To evaluate the level of anxiety thanks to Visual Analogue Scale (VAS) The VAS-anxiety is rated from 0 to 10

Trial Locations

Locations (1)

UH of Montpellier; 🇫🇷 Montpellier, France