Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT04031716
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.
This study is active but is not currently recruiting participants.
Notify Me8 year and older
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45229, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year
Pain scores will be collected preoperatively through 1 year postoperatively
Time frame: 1 year
Psychosocial measures will be collected preoperatively through 1 year postoperatively
Time frame: 8 weeks
Heart rate variability will be assessed preoperatively and postoperatively
Time frame: 8 weeks
Brain activity will be assessed preoperatively and postoperatively
Time frame: 8 weeks
Brain activity will be assessed preoperatively and postoperatively
Time frame: 8 weeks
Sleep efficiency and quality will be assessed preoperatively and postoperatively
Time frame: 72 hours postoperatively
Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase
Time frame: 8 weeks
Quantitative sensory testing will be assessed preoperatively and postoperatively
Children's Hospital Medical Center, Cincinnati
Other
Genetic, Epigenetic, Psychosocial, and Biological Determinants of Post-surgical Pain After Pectus or Spine Surgery
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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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