Post Surgical PainMNFNCT05838443
Mindfulness Surgical Pain Outcomes
A study testing Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation, Provider-directed mindfulness and Conventional Care in people with Post Surgical Pain and Surgery, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This will be a prospective randomized study to evaluate novel, clinically feasible, easily deliverable, pragmatic ways of preemptively modifying known CPSP and behavioral risk factors for acute to chronic pain transitions in adolescents before surgery. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Post Surgical Pain, Surgery
- What is being tested?
- Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation, Provider-directed mindfulness and Conventional Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 10-18 years
- English speaking
- Ability to provide assent/consent/parent permission
- Scheduled to undergo elective major musculoskeletal surgeries including spine fusion (idiopathic scoliosis only), abdominal surgeries, thoracic surgery including pectus repair, and major orthopedic joint surgeries.
Who cannot join
- Previous exposure to psychological interventions
- Surgery within 1 year
- Developmental delay
- Chronic opioid use within 6 months prior to surgery
- Severe systemic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229
About this study
Official title: Pragmatic Randomized Controlled Trial Evaluating Efficacy of Presurgical Provider-directed Behavioral and Self-directed Mindfulness Interventions in Pediatric Patients Undergoing Major Elective Surgical Procedures on Postoperative Pain Outcomes
This will be a prospective randomized study to evaluate novel, clinically feasible, easily deliverable, pragmatic ways of preemptively modifying known CPSP and behavioral risk factors for acute to chronic pain transitions in adolescents before surgery. In addition, it will provide mechanistic insights and build a strong foundation for future large scale interventional studies that can impact outcomes positively in children undergoing surgery.
- Conditions
- Post Surgical Pain, Surgery
- Being tested
- Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation, Provider-directed mindfulness, Conventional Care
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditationOther
Neurofeedback-assisted, technology-supported mindfulness via EEG-supported device delivered individually without the need for a facilitator or travel to training site. The device allows noninvasive neural activity recording from frontal and posterior brain regions. A dedicated smartphone application uses the EEG data to provide real-time adaptive feedback-modulating natural sounds to prompt user awareness of mind-wandering and intentional return to present experience. A smartphone app will guide patients through attention and focus on breath exercises. Patients will hear their distracted mind as the wind. Wind becomes stronger if their mind wanders, prompting patient's awareness of their wandering mind and guiding the patient back to focusing on their breath without judgment of how they are doing. Patients will be asked to practice mindfulness using the device for 20 minutes per day for 4 sessions prior to surgery.
Provider-directed mindfulnessOther
Patients will receive mental health support by a licensed social work provider who is trained in mindfulness through four 20-minute telehealth sessions. Patients will be taught cognitive behavioral therapy (CBT) techniques to reduce pain catastrophizing and increase coping efficacy, the clinician will review patient's current sleep routine and teach concepts and strategies to improve sleep. Patients will be guided through mindfulness and meditation exercises to improve pain and mood coping. Mindfulness-based instructions takes patients through quieting their mind by focusing on breath, expanding focus (i.e., "at the tip of their nose" "full flow of the breath"), with emphasis on acknowledgement of arising thoughts/emotions without judgement or emotional reaction, and return attention back to breath sensation. Principles of CBT and mindfulness will be reiterated at subsequent sessions.
Conventional CareOther
Control group, as defined by our institution's standard preoperative care for given procedure, which does not include psychological preparation.
| Study group | Role | What they receive |
|---|---|---|
| Self-directed mindfulness | Active comparator | Not described Receives: Other: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation |
| Provider-directed mindfulness | Active comparator | Not described Receives: Other: Provider-directed mindfulness |
| Conventional care | Other | Control Comparator Receives: Other: Conventional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Disability Index (FDI)
15-item survey that assesses the extent to which children experience difficulties in completing specific tasks (for example, walking to the bathroom, eating regular meals, and being at school all day).
Measured: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 4 months.
Secondary outcomes (6)
Child and Adolescent Mindfulness Measure (CAMM)
10-item to assess 3 out of 4 facets of mindfulness: observing, acting with awareness and accepting without judgement. Scale is 0-40 with reverse scoring 0-4, 0 being never true, 4 being always true. Higher scores correspond to higher levels of mindfulness.
Measured: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Child Anxiety Sensitivity Index (CASI)
18-item self-report tool designed to measure symptoms of anxiety in children and adolescents, with total scores ranging from 18-54. The CASI has demonstrated high internal consistency in both clinical and nonclinical samples (aged 8-15.8 years), good test-retest reliability and good construct validity.
Measured: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Electronic Pain Diary and PainDETECT
Numerical rating pain scores of average pain intensity based on electronic pain ratings for one week, activity and sleep, using free phone application ("Manage my Pain" for Android and "Pain Diary" for iPhone users). PainDETECT assesses pain nature, with high sensitivity, specificity and positive predictive accuracy in pain conditions.
Measured: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Perioperative Opioid use
Opioid use over 4 months (total morphine equivalent dose standardized by weight). Post-operative opioid use will be obtained from electronic medical record if patient was admitted, as well as by patient/family report.
Measured: Postoperative inpatient (if applicable), 1 week, 2 weeks and 3-4 months postoperatively.
PROMIS pain interference-short form
8 items assessing how pain interferes with daily activities such as ambulating and doing school work. Total score range 8-40.
Measured: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Pain Coping Efficacy
Evaluate pain coping as a mediator of association of the intervention with long-term functional and pain outcomes utilizing a 3-item subsurvey from a 39-item self-report questionnaire (PHQ pain coping questionnaire) to assess pain coping strategies and pain coping efficacy in children.
Measured: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Jan 2022
- Primary completion31 Mar 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Surgical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- The Society for Pediatric Anesthesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838443
- Sponsor's protocol ID
- 2022-0008
- Acronym
- MNF
- Status last verified
- Nov 2024
- First submitted
- 19 Apr 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial Evaluating Efficacy of Presurgical Provider-directed Behavioral and Self-directed Mindfulness Interventions in Pediatric Patients Undergoing Major Elective Surgical Procedures on Postoperative Pain Outcomes
- ClinicalTrials.gov ID
- NCT05838443
- Acronym / sponsor ID
- MNF / 2022-0008
- Conditions
- Post Surgical Pain, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- The Society for Pediatric Anesthesia
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective randomized study to evaluate novel, clinically feasible, easily deliverable, pragmatic ways of preemptively modifying known CPSP and behavioral risk factors for acute to chronic pain transitions in adolescents before surgery. In addition, it will provide mechanistic insights and build a strong foundation for future large scale interventional studies that can impact outcomes positively in children undergoing surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-directed mindfulness | Active comparator | Other: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation |
| Provider-directed mindfulness | Active comparator | Other: Provider-directed mindfulness |
| Conventional care | Other | Other: Conventional CareControl Comparator |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 10-18 years
- English speaking
- Ability to provide assent/consent/parent permission
- Scheduled to undergo elective major musculoskeletal surgeries including spine fusion (idiopathic scoliosis only), abdominal surgeries, thoracic surgery including pectus repair, and major orthopedic joint surgeries.
Key exclusion criteria (5 listed)
- Previous exposure to psychological interventions
- Surgery within 1 year
- Developmental delay
- Chronic opioid use within 6 months prior to surgery
- Severe systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditationNeurofeedback-assisted, technology-supported mindfulness via EEG-supported device delivered individually without the need for a facilitator or travel to training site. The device allows noninvasive neural activity recording from frontal and posterior brain regions. A dedicated smartphone application uses the EEG data to provide real-time adaptive feedback-modulating natural sounds to prompt user awareness of mind-wandering and intentional return to present experience. A smartphone app will guide patients through attention and focus on breath exercises. Patients will hear their distracted mind as the wind. Wind becomes stronger if their mind wanders, prompting patient's awareness of their wandering mind and guiding the patient back to focusing on their breath without judgment of how they are doing. Patients will be asked to practice mindfulness using the device for 20 minutes per day for 4 sessions prior to surgery. | Other | Self-directed mindfulness |
| Provider-directed mindfulnessPatients will receive mental health support by a licensed social work provider who is trained in mindfulness through four 20-minute telehealth sessions. Patients will be taught cognitive behavioral therapy (CBT) techniques to reduce pain catastrophizing and increase coping efficacy, the clinician will review patient's current sleep routine and teach concepts and strategies to improve sleep. Patients will be guided through mindfulness and meditation exercises to improve pain and mood coping. Mindfulness-based instructions takes patients through quieting their mind by focusing on breath, expanding focus (i.e., "at the tip of their nose" "full flow of the breath"), with emphasis on acknowledgement of arising thoughts/emotions without judgement or emotional reaction, and return attention back to breath sensation. Principles of CBT and mindfulness will be reiterated at subsequent sessions. | Other | Provider-directed mindfulness |
| Conventional CareControl group, as defined by our institution's standard preoperative care for given procedure, which does not include psychological preparation. | Other | Conventional care |
Primary outcome
Functional Disability Index (FDI)
Time frame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 4 months.
15-item survey that assesses the extent to which children experience difficulties in completing specific tasks (for example, walking to the bathroom, eating regular meals, and being at school all day).
6 secondary outcomes
Child and Adolescent Mindfulness Measure (CAMM)
Time frame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Child Anxiety Sensitivity Index (CASI)
Time frame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Electronic Pain Diary and PainDETECT
Time frame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Perioperative Opioid use
Time frame: Postoperative inpatient (if applicable), 1 week, 2 weeks and 3-4 months postoperatively.
PROMIS pain interference-short form
Time frame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Pain Coping Efficacy
Time frame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation, Provider-directed mindfulness and Conventional Care in people with Post Surgical Pain and Surgery, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Disability Index (FDI) (time frame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.