Mindfulness Surgical Pain Outcomes (MNF)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Surgery; Post Surgical Pain

Treatments: Other: Conventional Care; Other: Provider-directed mindfulness; Other: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT05838443

2022-0008

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 10-18 years
2. English speaking
3. Ability to provide assent/consent/parent permission
4. 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.

Exclusion criteria

1. Previous exposure to psychological interventions
2. Surgery within 1 year
3. Developmental delay
4. Chronic opioid use within 6 months prior to surgery
5. Severe systemic disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 3 patient groups

Self-directed mindfulness

Active Comparator group

Treatment:

Other: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation

Provider-directed mindfulness

Active Comparator group

Treatment:

Other: Provider-directed mindfulness

Conventional care

Other group

Description:

Control Comparator

Treatment:

Other: Conventional Care