An interventional study of Meditation in Pain, Postoperative, Excavatum, Pectus and Scoliosis Idiopathic, sponsored by Children's Hospital Medical Center, Cincinnati. Active, not recruiting at 1 site in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Supportive care
This will be a prospective observational 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 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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 600 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the control group will receive present standard of care, which includes an assessment of participant/family needs by integrative care after surgery, as well as standard holistic health care by a licensed/certified holistic health specialist. They will not receive the MUSETM focused-attention meditation training or intervention protocol.
Participants randomized to receive focused-attention meditation training will attend a preoperative training session, provided by a licensed/certified Holistic Health Specialist. The content will include an age appropriate explanation of focused-attention meditation, using breath as the focus; set-up and utilization of the MUSETM headband; and experiential practices. The goal of the intervention is to increase mindfulness (i.e., moment-to-moment, non-judgmental and non-reactive awareness of sensations, emotions, and thoughts), provide self-regulation strategies, and promote healthy and adaptive responses to stress.
Behavioral: Meditation
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.
Pain score trajectory
Pain scores will be collected preoperatively through 1 year postoperatively
Time frame: 1 year
Changes in self-reported psychosocial scores (including anxiety, pain, coping, physical limitation, etc.)
Psychosocial measures will be collected preoperatively through 1 year postoperatively
Time frame: 1 year
Changes in heart rate variability
Heart rate variability will be assessed preoperatively and postoperatively
Time frame: 8 weeks
Changes in mean amplitude values for lower, upper, and entire alpha frequency bands by group (intervention/no intervention) and time (pre-surgery/post-surgery)
Brain activity will be assessed preoperatively and postoperatively
Time frame: 8 weeks
Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks
Brain activity will be assessed preoperatively and postoperatively
Time frame: 8 weeks
Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality
Sleep efficiency and quality will be assessed preoperatively and postoperatively
Time frame: 8 weeks
Incidence of side-effect measures
Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase
Time frame: 72 hours postoperatively
Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index
Quantitative sensory testing will be assessed preoperatively and postoperatively
Time frame: 8 weeks
Plan to share: Yes — De-identified data may be shared with additional internal or external data warehouses/investigators. These include but are not limited to the i2b2-Research Data Warehouse protocol at CCHMC (IRB 2008-0834) for the purpose of linking this data to de-identified copies of the participants' electronic medical records via an i2b2 database. The resulting de-identified i2b2 database will not be part of this research, and will be used to explore secondary phenotypes in future research studies and the NIH-db-GaP (Database of Genotypes and Phenotypes).
Ran from Jul 2018 to primary completion in Dec 2025, 89 months.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 89 months is above that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
Completion moved once since we started tracking on Sep 25, 2026: Dec 2025 → Dec 2026, on Oct 8, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital Medical Center, Cincinnati →