Idiopathic Scoliosis Clinical Trial
Official title:
A Pilot Study of the Effectiveness of Complementary Therapies to Reduce Pain in Spinal Fusion Patients
Verified date | March 2016 |
Source | Nemours Children's Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 45 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).
Status | Completed |
Enrollment | 30 |
Est. completion date | March 27, 2017 |
Est. primary completion date | March 27, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 12 Years to 17 Years |
Eligibility |
Inclusion Criteria: 1. Females, ages 12 - 17 2. Diagnosis of idiopathic scoliosis Exclusion Criteria: 1. Patients with chronic or severe disease conditions requiring spinal fusion surgery. 2. Children with profound mental disabilities or developmental delay not allowing them to voluntarily assent to participate. |
Country | Name | City | State |
---|---|---|---|
United States | Nemours / A I duPont Hospital for Children | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Nemours Children's Clinic | Healing Touch Worldwide Foundation |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative pain (Total Opioid use) | Total Opioid use will be measured daily until discharge, and at postoperative follow-up visit | 4 weeks | |
Secondary | Clinical recovery (Postoperative parameters - nausea / vomiting; day of ambulation; transition to oral pain medication; length of stay followed daily until discharge) | 1 week | ||
Secondary | Cortisol level | Cortisol levels will be obtained at 4 points - pre-operative surgical evaluation visit, intra-operative, POD #2, 4-week postoperative follow-up clinic visit. | 5 weeks | |
Secondary | Anxiety (Child Pain Anxiety Symptoms Scale (CPASS) | The Child Pain Anxiety Symptoms Scale (CPASS) is a validated 20-item self-report tool measuring pain anxiety in adolescents undergoing major surgical procedures and will obtained on all participants at 3 points - presurgical evaluation, POD #2 and 4-week postoperative follow-up visit. | 5 weeks |
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