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Completed

NCT Number: NCT05805670

Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery

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.

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Key information

Conditions

Juvenile and Adolescent Idiopathic Scoliosis Anxiety Disorders Mental Disorders

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH of Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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

    • Not satisfied
    • Moderately satisfied
    • Satisfied

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: YOMEPOP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2023
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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