YOMEPOP: Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05805670

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Juvenile and Adolescent Idiopathic Scoliosis	Other: Yoga and Mindfulness	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Children with surgical indication scoliosis follow the Yoga and Mindfulness protocol before surgery 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 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

Arm

Intervention/Treatment

Experimental: Children with surgical indication scoliosis follow the Yoga and Mindfulness protocol before surgery

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

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

Outcome Measures

Primary Outcome Measures

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

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
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 Not satisfied Moderately satisfied Satisfied

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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