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Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery (YOMEPOP)

Primary Purpose

Juvenile and Adolescent Idiopathic Scoliosis

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Yoga and Mindfulness

About this trial

This is an interventional other trial for Juvenile and Adolescent Idiopathic Scoliosis focused on measuring Yoga, Meditation, Mindfulness, Anesthesia, Idiopathic Scoliosis Surgery, Anxiety, Children, Pediatric

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

UH of MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Intervention is a noninvasive approach. The protocol is composed of 5 sessions containing simple yoga postures and meditation audio supports to listen to.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

VAS-anxiety scores

To evaluate the level of anxiety thanks to Visual Analogue Scale (VAS) The VAS-anxiety is rated from 0 to 10

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)

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

Full Information

NCT ID

NCT05805670

First Posted

February 27, 2023

Last Updated

April 21, 2023

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT05805670

Brief Title

Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery

Acronym

YOMEPOP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 18, 2023 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Juvenile and Adolescent Idiopathic Scoliosis

Keywords

Yoga, Meditation, Mindfulness, Anesthesia, Idiopathic Scoliosis Surgery, Anxiety, Children, Pediatric

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention is a noninvasive approach. The protocol is composed of 5 sessions containing simple yoga postures and meditation audio supports to listen to.

Intervention Type

Other

Intervention Name(s)

Yoga and Mindfulness

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of patients with observance greater than or equal to 2

Description

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)

Time Frame

During the preoperative period

Secondary Outcome Measure Information:

Title

VAS-anxiety scores

Description

To evaluate the level of anxiety thanks to Visual Analogue Scale (VAS) The VAS-anxiety is rated from 0 to 10

Time Frame

From preoperative period up to 1 day postoperative

Title

FPS-R scores

Description

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)

Time Frame

From preoperative period up to 1 day postoperative

Title

Assessment of satisfaction of Yoga and Meditation protocol

Description

Satisfaction of parents and child will be rated from 1 to 3 Not satisfied Moderately satisfied Satisfied

Time Frame

The day before the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gabrielle VEISLINGER, MD

Phone

06.65.84.95.44

Ext

+33

g-burelli@chu-montpellier.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie BRINGUIER, PhD

Phone

04.67.33.86.61

Ext

+33

s-bringuierbranchereau@chu-montpellier.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabrielle VEISLINGER

Organizational Affiliation

Hospital of Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

UH of Montpellier

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabrielle VEISLINGER, MD

Phone

06.65.84.95.44

Ext

+33

g-burelli@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Sophie BRINGUIER, PhD

Phone

04.67.33.86.61

Ext

+33

s-bringuierbranchereau@chu-montpellier.fr

12. IPD Sharing Statement

Learn more about this trial

Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery

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