Complementary Therapies in Spinal Fusion Patients
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

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:

        1. Potential patients identified by Orthopedic surgery schedule and review of electronic
           medical record (EMR) for eligibility.

        2. Randomization of participants into group, CPASS anxiety scale and cortisol level
           obtained for all participants at preoperative visit.

        3. Day of surgery: Hypnosis intervention or Healing Touch intervention prior to surgical
           procedure by research staff

        4. 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.

        5. PACU procedure: Healing Touch intervention or Hypnosis intervention by research staff.

        6. POD #1 until discharge: daily Healing Touch or Hypnosis intervention by research staff

        7. POD # 2: CPASS anxiety scale and cortisol level obtained on all participants

        8. 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.

        9. 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.

       10. 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.
    

Intervention name(s): Hypnosis Therapy; Healing Touch Therapy
Intervention type(s): Other; Other
Intervention description(s): A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Complementary therapies; Hypnosis; Healing Touch