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

April 10, 2024 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • UH of Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with observance greater than or equal to 2
Time Frame: 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)
During the preoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS-anxiety scores
Time Frame: 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
From preoperative period up to 1 day postoperative
FPS-R scores
Time Frame: 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)
From preoperative period up to 1 day postoperative
Assessment of satisfaction of Yoga and Meditation protocol
Time Frame: 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
The day before the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Gabrielle VEISLINGER, Hospital of Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2023

Primary Completion (Actual)

March 16, 2024

Study Completion (Actual)

March 16, 2024

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL22_0057

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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