Hypnotherapy in Major Surgical Procedures

NCT02376634 | Withdrawn

• 1 other identifier: IRB14-00837
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Pectus Excavatum

Outcome Measures

Primary Outcomes (2)

• Pre-operative anxiety

  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.

  Day of surgery, just prior to the procedure

• Post-operative pain

  Total opiate consumption in the first 24 hours will be recorded.

  24 hours post-op

Study Arms (2)

Hypnosis

ACTIVE COMPARATOR

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.

Behavioral: Hypnosis

Control

NO INTERVENTION

This group will receive the standard of care of Nationwide Children's Hospital.

Interventions

Hypnosis BEHAVIORAL

Patients will be taught self-hypnosis.

Hypnosis

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• ASA classification III, IV (children with a chronic or severe disease).
• Children with neuromuscular disorders
• Children with developmental delay
• Patients with preexisting mental illness

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Scoliosis; Funnel Chest

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Developmental; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Complementary and Alternative Medicine

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 3, 2015
• Study Start: June 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2016-07

Locations

US (1)