Hypnotherapy in Major Surgical Procedures

Participants will be 60 children, aged 10-21, ASA 1 and 2 Classification, with idiopathic
scoliosis or congenital deformity of the chest wall, who are undergoing Nuss
procedure/scoliosis repair at the Nationwide Children's hospital. The design of this study
is a single-blinded randomized controlled trial-comparing pre-operative anxiety,
post-operative pain and other related symptoms in two groups of:

Group 1: Receives hypnosis (described below) Plus PCA Group 2: Standard of care (PCA)

Interventions:

Group I) Hypnosis: The hypnosis group will receive a semi-structured intervention by primary
investigator. The intervention is somewhat individualized based on the recipients personal
characteristics (e.g., age, gender, medical history). The intervention will begin with an
"induction" phase during which the participant is guided to relax and to focus their
attention on one stimuli. The intervention will then proceed with a "suggestion" phase.
Suggestions used in this phase will all be directed toward decreasing the patient's anxiety
and post-operative pain. Patients will be taught self-hypnosis to decrease distress and
reframe painful experiences.

Group II) Control: This group will receive the standard of care of Nationwide Children's
hospital.

Procedures:

1. Potential participants will be identified through review of the NCH surgery schedule
and assessed for eligibility by review of the electronic medical record using the
exclusionary criteria listed below.

2. In order to assure valid data, all anesthetic protocol will be standardized.

3. All patients will be randomized to the Hypnosis group and control group by another
member of the research team based on a randomization table. The patient's group
assignment will be placed in a sealed envelope prior to the day of surgery. Only PI can
access the envelope prior to the intervention. The PI will only perform the assigned
intervention while the research assistant and other health care providers are not
present. The research assistant and the peri-operative health care personnel will
remain blind to group assignment throughout data collection.

4. A research assistant will administer a brief assessment of state of anxiety (STAI) that
will take the patient at most 5 minutes to complete.

5. The research assistant will measure patient's blood pressure (BP) and heart rate (HR).

6. The PI will perform the clinical hypnotherapy intervention and teach self-hypnosis at
two points of time in Hypnosis group;

1. In pre-op visit prior to the surgery date

2. on the day of, prior to the procedure

7. A second research assistant will administer a second brief assessment of anxiety
(STAI), and measure HR and BP again.

8. Once the patient enters the operating room the standardized anesthetic protocol ( as
describe below) will be employed.

9. Following surgery, in the Post Anesthesia Care Unit (PACU) and floors we standardize
pain management with PCA orders.

10. Postoperative analgesia will be provided by hydromorphone delivered via a
patient-controlled analgesia (PCA) device with a bolus dose of 4-8 µg/kg and a lockout
period of 8-10 minutes. This may be increased up to 10 µg/kg as needed to achieve
optimal analgesia. No basal infusion will be administered for the PCA. The nursing
staff in post-anesthesia recovery unit and study staff collecting post-operative pain
scores until 24 hours post-operatively will be blinded as to the group assigned. The
subject's pain scores will be collected and recorded using the Visual Analogue Scale
(VAS) pain scale. Total opiate consumption in the first 24 hours will be recorded. The
need for medications to treat opiate-related side effects including naloxone or
ondansetron for pruritus or nausea respectively will be recorded. We will record the
number of deliveries and demands from the PCA device. We will also record the length of
hospital stay.

Measures

- State-Trait Anxiety Inventory (STAI)15. The STAI, completed by the patient to chart
their own anxiety level, is a 40-item self-report measure that contains 20 items
measuring state anxiety and 20 items measuring trait anxiety. Subjects are asked to
respond on a 4-point Likert scale. Total scores for state and trait portions separately
range from 20 to 80, with higher scores denoting higher levels of anxiety.

- Visual Analog Scale (VAS) The VAS is completed by the blind observer to chart their own
rating of the patient's pain. It is a 10cm line where the observer can mark a line
anywhere from "not anxious at all" to "very anxious"

- McGill Pain Questionnaire (MPQ). Sensory and effective dimensions of pain are measured
using the short MPQ, which consists of 15 pain descriptors that are rated on a 4-point
severity scale from 0 (none) to 3 (severe).

- Analgesic consumption. Analgesic consumption will be measured by recording the
analgesics administered to the study subjects.

- Clinical recovery. Postoperative parameters will be recorded including time to clear
fluid intake, voiding, and discharge from the hospital. The incidence of post-operative
complications, such as post-operative nausea and vomiting and post-operative
infections, will be noted as well.

- Global health questionnaire (GHQ). The GHQ is used to assess post-operative recovery;
items include sleep, strength and energy, self-assistance and movement. The subjects
rate every item on a six point Likert scale. The individual ratings are summed for a
total recovery score.

Inclusion Criteria:

1. Patients whose health status is American Society of Anesthesiologists (ASA) physical
status I to II, aged 10-21, with idiopathic scoliosis or congenital deformity of the
chest wall, who are undergoing Nuss procedure/scoliosis repair at the Nationwide
Children's hospital.

2. Parents/Guardian willing and able to authorize informed consent

3. Patients willing and able to authorize assent

Exclusion Criteria:

1. ASA classification III, IV (children with a chronic or severe disease).

2. Children with neuromuscular disorders

3. Children with developmental delay

4. Patients with preexisting mental illness