Pain Assessment in Children Undergoing Spine Surgery

May 3, 2022 updated by: Catherine Ferland

Peri-operative Pain Assessment in Children Undergoing Orthopaedic Surgery

Musculoskeletal (MSK) pain is one of the most common types of pain among children and adolescents. Recurring episodes of MSK pain conditions have a major impact on the daily lives. Children and adolescents with neuromuscular diseases are often unable to report the pain the patients experience because of intellectual and/or physical limitations. There is no reason to believe that pain is any less frequent or intense in these patients than in normally developing patients. Because of the elusive nature of pain in non-verbal children, therapeutic decisions are frequently based on vague proxy measures of pain and revert to a series of trials and errors. This project creates a unique opportunity to directly characterize and compare MSK and surgical pain subjectively in two different patient samples (verbal and non-verbal). The ultimate goal is to use this information to offer the highest quality of pain control in children with MSK conditions, and more specifically in children with limited communication skills unable to communicate their distress associated with the surgical procedural.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Improvement in the assessment techniques, to enable better pain management in children with intellectual and developmental disabilities who are unable to describe the intensity of the postsurgical pain, is a cornerstone of our research program. This research project will elucidate the regulation of specific markers of global surgical insult (nociception, inflammation, stress responses) associated to specific physiological mechanisms related to pain in children with and without verbal skills undergoing major orthopaedic surgery. This project creates a unique opportunity to directly characterize and compare MSK and surgical pain subjectively in the two different patient samples (verbal and non-verbal). As molecular events of pathophysiological processes are quantifiable, the investigators will test for associations between the expression of front-running pain biomarkers in physiological fluids (blood and saliva) and the experience of pain in two patient samples (verbal and non-verbal) undergoing major orthopaedic surgery. The identification of biomarkers will provide a deeper understanding of a patient's pain perception alongside self-report or observers' report subjective measurements. Even with standardization of best practice perioperative anesthetic pain management, children undergoing similar surgical procedures experience pain at different intensity. Based on preliminary findings, treatment modalities appear to be ineffective in one out of five patients. Pain experience variability may originate in the lack of rigor in the clinical pain assessment tools. Tools such as numerical rating scales used in the perioperative period are not based on objective patient specific pain thresholds. A personalized mechanism-based approach may be the key to better identify a patient's postsurgical pain outcome and how this assessment could lead to personalized perioperative pain management. The ultimate goal is to use this information to offer the highest quality of pain control in children with MSK conditions, and more specifically in children with limited communication skills unable to communicate their distress associated with the surgical procedures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A0A9
        • Shriners Hospital for Children-Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 10 and 21 years old
  • Scheduled to undergo posterior or anterior spinal fusion surgery for AIS with instrumentation
  • Ability to adequately understand and respond to outcome measures
  • No previous major orthopedic surgery
  • Female or male
  • Any ethnic background

Exclusion Criteria:

  • Inability of the child to speak English or French
  • Diagnosed with developmental delay that would interfere with understanding questions being asked (autism, mental retardation)
  • Children with major chronic medical conditions (ASA status III or higher)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Verbal Patients
Behavioral: Pain assessment for verbal patients
The pain profile of the patient will be assessed at each time point including biological sample analysis (blood and saliva), quantitative sensory testing (mechanical and thermal), and psychological state via the completion of questionnaires by the patient.
Active Comparator: Non-verbal Patients
Behavioral: Pain assessment for non-verbal patients
The pain profile of the patient will be assessed at each time point including biological sample analysis (blood and saliva), quantitative sensory testing (mechanical), and psychological state via the completion of questionnaires by the parent of the patient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time Frame: Baseline
Baseline
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time Frame: Postoperative day 1
Postoperative day 1
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time Frame: Postoperative day 2
Postoperative day 2
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time Frame: Postoperative day 5
Postoperative day 5
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time Frame: 6 weeks postoperative
6 weeks postoperative
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time Frame: 6 months postoperative
6 months postoperative
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time Frame: 1 year postoperative
1 year postoperative
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time Frame: 2 years postoperative
2 years postoperative
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time Frame: Baseline
Baseline
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time Frame: Postoperative day 1
Postoperative day 1
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time Frame: Postoperative day 2
Postoperative day 2
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time Frame: Postoperative day 5
Postoperative day 5
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time Frame: 6 weeks postoperative
6 weeks postoperative
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time Frame: 6 months postoperative
6 months postoperative
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time Frame: 1 year postoperative
1 year postoperative
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time Frame: 2 years postoperative
2 years postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame: Baseline
Baseline
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame: Baseline
Baseline
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Time Frame: Baseline
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Baseline
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame: Postoperative day 1
Postoperative day 1
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame: Postoperative day 1
Postoperative day 1
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame: Postoperative day 2
Postoperative day 2
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame: Postoperative day 2
Postoperative day 2
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame: Postoperative day 5
Postoperative day 5
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame: Postoperative day 5
Postoperative day 5
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Time Frame: Postoperative day 5
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Postoperative day 5
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame: 6 weeks postoperative
6 weeks postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame: 6 weeks postoperative
6 weeks postoperative
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Time Frame: 6 weeks postoperative
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
6 weeks postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame: 6 months postoperative
6 months postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame: 6 months postoperative
6 months postoperative
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Time Frame: 6 months postoperative
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
6 months postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame: 1 year postoperative
1 year postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame: 1 year postoperative
1 year postoperative
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Time Frame: 1 year postoperative
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
1 year postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame: 2 years postoperative
2 years postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame: 2 years postoperative
2 years postoperative
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Time Frame: 2 years postoperative
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
2 years postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time Frame: Baseline
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Baseline
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time Frame: Postoperative day 1
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Postoperative day 1
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time Frame: Postoperative day 2
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Postoperative day 2
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time Frame: Postoperative day 5
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Postoperative day 5
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time Frame: 6 weeks postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 weeks postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time Frame: 6 months postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 months postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time Frame: 1 year postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
1 year postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time Frame: 2 years postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
2 years postoperative
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
Time Frame: Baseline
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
Baseline
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
Time Frame: 6 weeks postoperative
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
6 weeks postoperative
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
Time Frame: 6 months postoperative
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
6 months postoperative
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
Time Frame: 1 year postoperative
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
1 year postoperative
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
Time Frame: 2 years postoperative
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
2 years postoperative
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Time Frame: Baseline
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Baseline
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Time Frame: 6 weeks postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 weeks postoperative
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Time Frame: 6 months postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 months postoperative
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Time Frame: 1 year postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
1 year postoperative
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Time Frame: 2 years postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
2 years postoperative
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Time Frame: Baseline
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Baseline
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Time Frame: Baseline
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Baseline
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Time Frame: Day of surgery
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Day of surgery
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Time Frame: Day of surgery
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Day of surgery
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Time Frame: 6 weeks postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 weeks postoperative
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Time Frame: 6 weeks postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 weeks postoperative
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Time Frame: 6 months postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 months postoperative
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Time Frame: 6 months postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 months postoperative
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Time Frame: 1 year postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
1 year postoperative
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Time Frame: 1 year postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
1 year postoperative
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Time Frame: 2 years postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
2 years postoperative
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Time Frame: 2 years postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
2 years postoperative
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Time Frame: Baseline
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Baseline
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Time Frame: Postoperative day 1
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Postoperative day 1
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Time Frame: Postoperative day 2
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Postoperative day 2
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Time Frame: Postoperative day 5
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Postoperative day 5
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Time Frame: 6 weeks postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 weeks postoperative
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Time Frame: 6 months postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 months postoperative
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Time Frame: 1 year postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
1 year postoperative
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Time Frame: 2 years postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
2 years postoperative
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Time Frame: Baseline
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Baseline
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Time Frame: Postoperative day 1
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Postoperative day 1
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Time Frame: Postoperative day 2
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Postoperative day 2
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Time Frame: Postoperative day 5
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Postoperative day 5
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Time Frame: 6 weeks postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 weeks postoperative
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Time Frame: 6 months postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
6 months postoperative
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Time Frame: 1 year postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
1 year postoperative
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Time Frame: 2 years postoperative
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
2 years postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catherine Ferland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine Ferland, Shriners Hospitals for Children,Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A08M7114B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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