Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery

NCT ID: NCT05805670

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-18

Study Completion Date

2024-03-16

Brief Summary

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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

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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.

Conditions

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Juvenile and Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Yoga and Mindfulness

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabrielle VEISLINGER

Role: PRINCIPAL_INVESTIGATOR

Hospital of Montpellier

Locations

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UH of Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL22_0057

Identifier Type: -

Identifier Source: org_study_id

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