N/A
N=30
Complementary Therapies in Spinal Fusion Patients
Idiopathic Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT02409615 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Aug 2024
Primary outcome: Primary: Postoperative Pain (Total Opioid Use) — 0.041; 0.048; 0.054; 0.038 mg/kg/hr
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypnosis Therapy (Other); Healing Touch Therapy (Other)
- Age
- Pediatric · 12+ yrs
- Sex
- Female
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain (Total Opioid Use) |
0.041; 0.048; 0.054; 0.038; 0.042; 0.042 | — |
| SECONDARY Pain Score |
0.11; 0.5; 1.5; 5.0; 4.7; 6.2 | — |
| SECONDARY Cortisol Level |
4.36; 6.07; 5.03; 2.94; 3.28; 3.25 | — |
| SECONDARY Child Pain Anxiety Symptoms Scale (CPASS) |
19.6; 18.0; 30.3; 41.7; 41.33; 48.6 | — |
Summary
In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing touch as adjunct therapies to the standard of care, will improve analgesic use for post operative pain. In this pilot study the investigators will randomize 30 adolescents undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of Care, and a control group (Pain Management Standard of Care only).
Eligibility Criteria
Inclusion Criteria
- Females, ages 12 - 17
- Diagnosis of idiopathic scoliosis
Exclusion Criteria
- Patients with chronic or severe disease conditions requiring spinal fusion surgery.
- Children with profound mental disabilities or developmental delay not allowing them to voluntarily assent to participate.
Data sourced from ClinicalTrials.gov (NCT02409615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.