Complementary Therapies in Spinal Fusion Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-03-27

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Idiopathic Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypnosis Group

Hypnosis Group: ten participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol

Group Type ACTIVE_COMPARATOR

Hypnosis Therapy

Intervention Type OTHER

A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness

Healing Touch Group

Healing Touch Group: ten participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol

Group Type ACTIVE_COMPARATOR

Healing Touch Therapy

Intervention Type OTHER

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.

Control Group

Control Group: ten participants will receive standard postoperative pain management protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hypnosis Therapy

A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness

Intervention Type OTHER

Healing Touch Therapy

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes