Hand Holding During Light Sedation for Minimally Invasive Spine Surgery Improves Outcomes

Spine Clinical Trial

— HHLS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058079
• Other study ID #: 1678933
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Rhode Island Hospital
• Contact: Joseph Caiati, MD
• Phone: 401-444-5172
• Email: jcaiati[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Minimally Invasive
• Spine

Intervention

Behavioral:
• Intraoperative Hand Held
Intraoperative hand holding

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dexter F, Candiotti KA. Multicenter assessment of the Iowa Satisfaction with Anesthesia Scale, an instrument that measures patient satisfaction with monitored anesthesia care. Anesth Analg. 2011 Aug;113(2):364-8. doi: 10.1213/ANE.0b013e318217f804. Epub 2011 Apr 25. — View Citation

Kwon WA, Lee JW, Seo HK, Oh TH, Park SC, Jeong HJ, Seo IY. Hand-Holding during Cystoscopy Decreases Patient Anxiety, Pain, and Dissatisfaction: A Pilot Randomized Controlled Trial. Urol Int. 2018;100(2):222-227. doi: 10.1159/000485745. Epub 2017 Dec 22. — View Citation

Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iowa Satisfaction with Anesthesia Scale (ISAS)	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.	24 hours after the procedure
Secondary	Pain Score	Numerical pain score (0=no pain, 10=worst pain imaginable)	Through study completion up to 24 hours after procedure.
Secondary	State Trait Anxiety Inventory (STAI)	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.	Before and 24 hours after the procedure