Complementary Therapies in Spinal Fusion Patients
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 9/14/2017 |
| Start Date: | August 2014 |
| End Date: | March 27, 2017 |
A Pilot Study of the Effectiveness of Complementary Therapies to Reduce Pain in Spinal Fusion Patients
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).
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).
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.
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.
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.
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