Hypnotherapy in Major Surgical Procedures
|ClinicalTrials.gov Identifier: NCT02376634|
Recruitment Status : Withdrawn (PI left Nationwide Children's Hosp.)
First Posted : March 3, 2015
Last Update Posted : September 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Scoliosis Pectus Excavatum||Behavioral: Hypnosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
Patients will be taught self-hypnosis.
No Intervention: Control
This group will receive the standard of care of Nationwide Children's Hospital.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376634
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|