Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery

NCT05805670 | Completed

• 1 other identifier: RECHMPL22_0057
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile and Adolescent Idiopathic Scoliosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• VAS-anxiety scores

  From preoperative period up to 1 day postoperative

• FPS-R scores

  From preoperative period up to 1 day postoperative

• Assessment of satisfaction of Yoga and Meditation protocol

  The day before the surgery

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Yoga and Mindfulness 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

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

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 8 to 17 years
• Female and male gender
• Planned idiopathic scoliosis surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Yoga; Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gabrielle VEISLINGER

  Hospital of Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 10, 2023
• Study Start: April 18, 2023
• Primary Completion: March 16, 2024
• Study Completion: March 16, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

FR (1)