The Effectiveness of Clinical Hypnotherapy in Reducing Anxiety and Pain in Major Surgical Procedures (Nuss and Scoliosis Repair)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Pre-operative anxiety
Study Overview
Brief Summary
The purpose of this randomized controlled study is to test the feasibility of clinical hypnotherapy as a perioperative intervention for the reduction of pre-operative anxiety, post-operative pain, and other-related symptoms (nausea, vomiting, spasms, length of stay, self mastery) in children undergoing scoliosis repair or Nuss procedure.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Parents/Guardian willing and able to authorize informed consent
- •Patients willing and able to authorize assent
Exclusion Criteria
- •ASA classification III, IV (children with a chronic or severe disease).
- •Children with neuromuscular disorders
- •Children with developmental delay
- •Patients with preexisting mental illness
Arms & Interventions
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.
Intervention: Hypnosis (Behavioral)
Control
This group will receive the standard of care of Nationwide Children's Hospital.
Outcomes
Primary Outcomes
Pre-operative anxiety
Time Frame: Day of surgery, just prior to the procedure
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.
Post-operative pain
Time Frame: 24 hours post-op
Total opiate consumption in the first 24 hours will be recorded.
Secondary Outcomes
No secondary outcomes reported
Investigators
Haleh Saadat
Director of Complementary and Alternative Medicine
Nationwide Children's Hospital