---
title: Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
nct_id: NCT04031716
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: "Children's Hospital Medical Center, Cincinnati"
study_type: INTERVENTIONAL
primary_condition: Pain, Postoperative
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04031716.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04031716"
ct_last_update_post_date: 2025-06-13
last_seen_at: "2026-05-12T06:40:13.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery

**Official Title:** Genetic, Epigenetic, Psychosocial, and Biological Determinants of Post-surgical Pain After Pectus or Spine Surgery

**NCT ID:** [NCT04031716](https://clinicaltrials.gov/study/NCT04031716)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 600
- **Lead Sponsor:** Children's Hospital Medical Center, Cincinnati
- **Conditions:** Pain, Postoperative, Excavatum, Pectus, Scoliosis Idiopathic
- **Start Date:** 2018-07-06
- **Completion Date:** 2025-12-31
- **CT.gov Last Update:** 2025-06-13

## 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.

## Eligibility

- **Minimum age:** 8 Years
- **Sex:** ALL
- **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
```

## Arms

- **Control** (NO_INTERVENTION) — 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.
- **Meditation** (EXPERIMENTAL) — 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.

## Interventions

- **Meditation** (BEHAVIORAL) — 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.

## Primary Outcomes

- **Pain score trajectory** _(time frame: 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.)** _(time frame: 1 year)_ — Psychosocial measures will be collected preoperatively through 1 year postoperatively
- **Changes in heart rate variability** _(time frame: 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)** _(time frame: 8 weeks)_ — Brain activity will be assessed preoperatively and postoperatively
- **Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks** _(time frame: 8 weeks)_ — Brain activity will be assessed preoperatively and postoperatively
- **Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality** _(time frame: 8 weeks)_ — Sleep efficiency and quality will be assessed preoperatively and postoperatively
- **Incidence of side-effect measures** _(time frame: 72 hours postoperatively)_ — Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase

## Secondary Outcomes

- **Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index** _(time frame: 8 weeks)_

## Locations (1)

- Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cincinnati childrens hospital medical center|cincinnati|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04031716.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04031716*  
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