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Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery

Primary Purpose

Pain, Postoperative, Excavatum, Pectus, Scoliosis Idiopathic

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Meditation, Pectus Excavatum, Scoliosis

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Childrens Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Meditation

Arm Description

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.

Outcomes

Primary Outcome Measures

Pain score trajectory
Pain scores will be collected preoperatively through 1 year postoperatively
Changes in self-reported psychosocial scores (including anxiety, pain, coping, physical limitation, etc.)
Psychosocial measures will be collected preoperatively through 1 year postoperatively
Changes in heart rate variability
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)
Brain activity will be assessed preoperatively and postoperatively
Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks
Brain activity will be assessed preoperatively and postoperatively
Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality
Sleep efficiency and quality will be assessed preoperatively and postoperatively
Incidence of side-effect measures
Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase

Secondary Outcome Measures

Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index
Quantitative sensory testing will be assessed preoperatively and postoperatively

Full Information

First Posted
September 20, 2018
Last Updated
December 7, 2022
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04031716
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 6, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Excavatum, Pectus, Scoliosis Idiopathic
Keywords
Meditation, Pectus Excavatum, Scoliosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Meditation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Intervention Description
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 Outcome Measure Information:
Title
Pain score trajectory
Description
Pain scores will be collected preoperatively through 1 year postoperatively
Time Frame
1 year
Title
Changes in self-reported psychosocial scores (including anxiety, pain, coping, physical limitation, etc.)
Description
Psychosocial measures will be collected preoperatively through 1 year postoperatively
Time Frame
1 year
Title
Changes in heart rate variability
Description
Heart rate variability will be assessed preoperatively and postoperatively
Time Frame
8 weeks
Title
Changes in mean amplitude values for lower, upper, and entire alpha frequency bands by group (intervention/no intervention) and time (pre-surgery/post-surgery)
Description
Brain activity will be assessed preoperatively and postoperatively
Time Frame
8 weeks
Title
Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks
Description
Brain activity will be assessed preoperatively and postoperatively
Time Frame
8 weeks
Title
Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality
Description
Sleep efficiency and quality will be assessed preoperatively and postoperatively
Time Frame
8 weeks
Title
Incidence of side-effect measures
Description
Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase
Time Frame
72 hours postoperatively
Secondary Outcome Measure Information:
Title
Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index
Description
Quantitative sensory testing will be assessed preoperatively and postoperatively
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vidya Chidambaran, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
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Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery

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