Minimally Invasive, Spine
Conditions
Brief summary
The investigators want to determine whether handholding improves patient satisfaction and reduce patient's anxiety during minimally invasive outpatient spine surgery with monitored anesthesia care.
Detailed description
Minimally invasive spine interventions have emerged as a treatment options for patients with previous spine surgery and patients who have never before been operated upon. These procedures can be done safely in patients with advanced comorbid conditions, previous failed major spine procedures, and in patients who have decided to try the least invasive approach to address their lumbo-sacral spine condition in hopes of avoiding more major and potentially morbid procedures. These endoscopic procedures are typically done as outpatients with light sedation, ideally rendering the patient calm but completely cooperative and able to respond in real-time to questions from the surgeon during the procedure. This has implications for the progress and success of the procedure, the safety of the procedure and allows for a short ambulatory hospital stay. Hand holding has been shown to improve outcomes such as compliance, procedural success and patient comfort with patients undergoing light sedation for a variety of procedures. The purpose of this study is to determine whether adding hand holding to light sedation for minimally invasive spine procedures has a positive impact on patient satisfaction and perioperative outcomes.
Interventions
BEHAVIORALIntraoperative Hand Held
Intraoperative hand holding
Sponsors
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiology physical status 1 to 3 * Outpatient endoscopic spine procedures under light sedation
Exclusion criteria
* American Society of Anesthesiology physical status 4 or greater * Pre-existing neuropathy * Infection at the site * Pregnancy * Patient's refusal or inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Iowa Satisfaction with Anesthesia Scale (ISAS) | 24 hours after the procedure | 11-item questionnaire designed to measure the satisfaction with monitored anesthesia care. The Iowa Satisfaction with Anesthesia Scale (ISAS) score is the mean of responses to all 11questions. The score can range from a min of -3 to a maximum of +3. The responses are : -3 = disagree very much, -2 = disagree moderately, -1 = disagree slightly, 1 = agree slightly, 2 = agree moderately, and 3 = agree very much. A score of +3 would imply a totally satisfied patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Through study completion up to 24 hours after procedure. | Numerical pain score (0=no pain, 10=worst pain imaginable) |
| State Trait Anxiety Inventory (STAI) | Before and 24 hours after the procedure | The 6-item version of the Spielberger 20-item State-Trait Anxiety Inventory (STAI) is a validated short form and correlates well with the standard inventory. It measures state anxiety (how one feels at the moment: feel questions) and trait anxiety (how one generally feels: am questions). It contains six questions with a Likert scale from 1 to 4 (1=not at all, 2=somewhat, 3=moderately so, 4=very much so) The score range is from a minimum of 6 to a maximum of 24. A low score represents no to low anxiety where as a high score represents high anxiety. |
Countries
United States
Contacts
Primary ContactJoseph Caiati, MD
Backup ContactMark Kendall, MD
Outcome results
None listed