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Hypnotherapy in Major Surgical Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376634
Recruitment Status : Withdrawn (PI left Nationwide Children's Hosp.)
First Posted : March 3, 2015
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Haleh Saadat, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Scoliosis Pectus Excavatum Behavioral: Hypnosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Clinical Hypnotherapy in Reducing Anxiety and Pain in Major Surgical Procedures (Nuss and Scoliosis Repair)
Study Start Date : June 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Scoliosis

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Hypnosis
Patients will be taught self-hypnosis.

No Intervention: Control
This group will receive the standard of care of Nationwide Children's Hospital.



Primary Outcome Measures :
  1. 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.

  2. Post-operative pain [ Time Frame: 24 hours post-op ]
    Total opiate consumption in the first 24 hours will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376634


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
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Responsible Party: Haleh Saadat, Director of Complementary and Alternative Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02376634    
Other Study ID Numbers: IRB14-00837
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Scoliosis
Funnel Chest
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Developmental
Musculoskeletal Abnormalities
Congenital Abnormalities