The Effect of Hand Holding on Patient Satisfaction During for Minimally Invasive Spine Surgery Under Monitored Anesthesia Care. A Single Blinded, Single Center Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spine
- Sponsor
- Rhode Island Hospital
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Iowa Satisfaction with Anesthesia Scale (ISAS)
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Iowa Satisfaction with Anesthesia Scale (ISAS)
Time Frame: 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 Outcomes
- State Trait Anxiety Inventory (STAI)(Before and 24 hours after the procedure)
- Pain Score(Through study completion up to 24 hours after procedure.)