Complementary Therapies in Spinal Fusion Patients

Study Overview
=================
Brief 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 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).

Detailed Description
-----------------
Female adolescents with the diagnosis of idiopathic scoliosis requiring surgery will be approached by a member of the research team at the pre-surgical evaluation visit to participate in the study. Randomization will be done at the time of the pre-surgical visit. Microsoft Excel will be used to generate a random group assignment table to one of the following groups: CONTROL GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery HYPNOSIS GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion and Hypnosis intervention consisting of induction to achieve a state of focused attention with heightened receptivity for acceptable suggestions targeting relaxation, comfort and healing. HEALING TOUCH GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery and Healing Touch intervention (Chakra Connection, Magnetic Clearing) Protocol: Potential patients identified by Orthopedic surgery schedule and review of electronic medical record (EMR) for eligibility. Randomization of participants into group, CPASS anxiety scale and cortisol level obtained for all participants at preoperative visit. Day of surgery: Hypnosis intervention or Healing Touch intervention prior to surgical procedure by research staff Intra-operative procedure: Hypnosis participant will have taped Hypnosis script during surgical procedure; Healing Touch participant will receive one minute of intentional healing at designated time each hour by Healing Touch Practitioner. Cortisol level will be obtained on all participants. PACU procedure: Healing Touch intervention or Hypnosis intervention by research staff. POD #1 until discharge: daily Healing Touch or Hypnosis intervention by research staff POD # 2: CPASS anxiety scale and cortisol level obtained on all participants Post-op analgesic regimen: Morphine PCA > 50 kg (demand 1 mg, 10 minute lockout, basal rate 0.5 mg/hr) and Morphine PCA < 40-49 kg (demand 0.8 mg, 10 minute lockout, basal rate 0.4 mg/hr), benzodiazepine, gabapentin, ketorolac and clonidine per standard protocol for all participants. Pain scores (self-report), vital signs, opioid consumption, side effects, day of ambulation, transition to oral analgesics will be collected from EMR until day of discharge. 4-week Postoperative visit: CPASS anxiety scale, cortisol level and pill count obtained on all participants. Methods: Statistical Analysis: Descriptive Statistics: Standard Descriptive Statistics will be used to describe the outcomes, demographic and independent variables of interest pre- and post-intervention, overall and by intervention group. Changes in outcomes will also be calculated and descried. For continuous variables means, medians and ranges will be produced, while frequencies and percentages will be produced for categorical variables. Means, standard deviations, medians and ranges will be computed for measured continuous variables; marginal distributions will be used for categorical factors. Graphical methods including histograms, scatterplots, and boxplots, will be used in order to understand aspects of data quantity and examine assumptions (such as normality) underlying statistical models. The primary outcome is decrease in opioid consumption as well as reported pain and anxiety scores. We will compare difference in pain pre- to post- between the two intervention and control groups, using ANOVA. Since data will be collected at multiple points pre- and post-intervention, and some randomly missing data expected, the primary analysis will employ generalized estimating equations (GEEs). The GEEs models will be adjusted for baseline characteristics, such as age, gender, race and any important clinical characteristics. GEEs will also be used to compare the changes in reported pain and analgesic use between the three groups.

Official Title
-----------------
A Pilot Study of the Effectiveness of Complementary Therapies to Reduce Pain in Spinal Fusion Patients

Conditions
-----------------
Idiopathic Scoliosis

Intervention / Treatment
-----------------
* Other: Hypnosis Therapy
* Other: Healing Touch Therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypnosis Group<br>Hypnosis Group: fifteen participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol | Other: Hypnosis Therapy<br>* A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness<br>|
| Active Comparator: Healing Touch Group<br>Healing Touch Group: fifteen participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol | Other: Healing Touch Therapy<br>* Healing Touch An energery based therapy that uses light body or above body touch to help balance the energy field and energy centers of the body to restore harmony within the body for greater healing.<br>|
| No Intervention: Control Group<br>Control Group will receive standard postoperative pain management protocol | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain (Total Opioid use) | Total Opioid use will be measured daily until discharge, and at postoperative follow-up visit | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical recovery (Postoperative parameters - nausea / vomiting; day of ambulation; transition to oral pain medication; length of stay followed daily until discharge) |  | 1 week | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complementary therapies, Healing Touch, Hypnosis