Excavatum, Pectus, Pain, Postoperative, Scoliosis Idiopathic
Conditions
Keywords
Meditation, Pectus Excavatum, Scoliosis
Brief summary
This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.
Detailed description
This study will be a clinical prospective study. It is observational for all aims except with regard to the Meditation Intervention, which will be limited to 100 pectus and 100 spine participants (randomized to 50/50 in each arm). We will recruit 600 qualifying participants over the study period to acquire the necessary data to derive a predictive model matching phenotype to genotype. This study will not interfere with the standard anesthetic or perioperative care except for blood sampling from an indwelling line, and the use of additional integrative health procedures (focused-attention meditation guidance, as well as routine massage and breathing techniques) for the randomized meditation group. Research staff will administer psychosocial and somatosensory assessments, as well as record relevant data from participant's medical records. Integrative health will assist in teaching focused-attention meditation to the randomized meditation participants in the preoperative phase. Actigraphy devices will be provided to all participants, and MUSETM to those in the randomized meditation group. The pain team, in accordance with the Pectus Pain Management Protocol, will direct perioperative pain management.
Interventions
BEHAVIORALMeditation
Participants assigned to the Meditation intervention will receive focused attention meditation training preoperatively, and encouraged to meditate for 20 minutes per day before surgery. In the postoperative inpatient period, the participants will be offered standard holistic health care, reinforcement of meditation training, and encouragement to practice at least 20 minutes of guided focused-attention meditation with breath as their focus, utilizing the MUSETM headband for bio-feedback, every day during their hospital stay. They will be asked to continue using the MUSETM neurofeedback-assisted meditation after hospital discharge, until their visit to repeat pain testing, at which time they will return the MUSETM headband.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All participants will receive standard perioperative care, anesthetic management, and postoperative pain management per institutional standardized practices. Participants will be randomized into either the Meditation or Control Groups, as deemed appropriate.
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Children aged 8 years of age through adulthood * Diagnosis of pectus excavatum or adolescent idiopathic scoliosis * Scheduled for endoscopic pectus excavatum repair or spine fusion
Exclusion criteria
* History of or active renal or liver disease * Major surgery requiring opioids in the last 5 years * Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month) * Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included * History of seizures currently treated on medication (participants off medication and seizure free for greater than one year may be included) * Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine * Needing postoperative ventilation or intraoperative cardiac bypass standby * BMI \>35 * Pregnant or breastfeeding females * Non-English speaking * Definite developmental delay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality | 8 weeks | Sleep efficiency and quality will be assessed preoperatively and postoperatively |
| Incidence of side-effect measures | 72 hours postoperatively | Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase |
| Pain score trajectory | 1 year | Pain scores will be collected preoperatively through 1 year postoperatively |
| Changes in self-reported psychosocial scores (including anxiety, pain, coping, physical limitation, etc.) | 1 year | Psychosocial measures will be collected preoperatively through 1 year postoperatively |
| Changes in heart rate variability | 8 weeks | Heart rate variability will be assessed preoperatively and postoperatively |
| Changes in mean amplitude values for lower, upper, and entire alpha frequency bands by group (intervention/no intervention) and time (pre-surgery/post-surgery) | 8 weeks | Brain activity will be assessed preoperatively and postoperatively |
| Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks | 8 weeks | Brain activity will be assessed preoperatively and postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index | 8 weeks | Quantitative sensory testing will be assessed preoperatively and postoperatively |
Countries
United States
Outcome results
None listed