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Mindfulness Techniques for Postoperative Pain (MNF Trial)

N/A
Waitlist Available
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months
Awards & highlights

MNF Trial Summary

This trial will test new ways to reduce pain and risk factors for chronic pain in kids before surgery, and provide insight to help improve results.

Who is the study for?
This trial is for English-speaking adolescents aged 10-18 who are about to have major elective surgeries like spine fusion or joint surgery. They must be able to agree to the study themselves or with a parent's permission. It's not for those who've had psychological treatments, used opioids regularly in the last 6 months, had surgery within a year, or have developmental delays or severe diseases.Check my eligibility
What is being tested?
The study tests how self-directed and provider-directed mindfulness practices can prevent chronic pain after surgery using an EEG device with neurofeedback. These methods are compared against conventional care in a randomized setup where participants don't choose their treatment group.See study design
What are the potential side effects?
Mindfulness interventions typically do not cause physical side effects but may include temporary feelings of frustration, emotional discomfort, and increased awareness of negative emotions during practice.

MNF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline pre-intervention, post-operatively at 1 week, 2 weeks and 4 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline pre-intervention, post-operatively at 1 week, 2 weeks and 4 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional Disability Index (FDI)
Secondary outcome measures
Child Anxiety Sensitivity Index (CASI)
Child and Adolescent Mindfulness Measure (CAMM)
Electronic Pain Diary and PainDETECT
+3 more

MNF Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Conventional careExperimental Treatment1 Intervention
Control Comparator
Group II: Self-directed mindfulnessActive Control1 Intervention
Group III: Provider-directed mindfulnessActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The Society for Pediatric AnesthesiaOTHER
3 Previous Clinical Trials
5,000,243 Total Patients Enrolled
1 Trials studying Surgery
5,000,000 Patients Enrolled for Surgery
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,530,580 Total Patients Enrolled
5 Trials studying Surgery
5,000,458 Patients Enrolled for Surgery

Media Library

Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation Clinical Trial Eligibility Overview. Trial Name: NCT05838443 — N/A
Surgery Research Study Groups: Self-directed mindfulness, Provider-directed mindfulness, Conventional care
Surgery Clinical Trial 2023: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation Highlights & Side Effects. Trial Name: NCT05838443 — N/A
Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838443 — N/A
~27 spots leftby May 2025
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