This trial will study whether handholding improves patient satisfaction and reduces anxiety during minimally invasive outpatient spine surgery while the patient is under monitored anesthesia care.
- Minimally Invasive Surgery
1 Primary · 2 Secondary · Reporting Duration: Through study completion up to 24 hours after procedure.
2 Treatment Groups
1 of 2
No hand holding group
1 of 2
154 Total Participants · 2 Treatment Groups
Primary Treatment: Hand-held group · No Placebo Group · N/A
Who is running the clinical trial?
Age 18 - 80 · All Participants · 2 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Dexter, Franklin, and Keith A. Candiotti. 2011. “Multicenter Assessment of the Iowa Satisfaction with Anesthesia Scale, an Instrument That Measures Patient Satisfaction with Monitored Anesthesia Care”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e318217f804.
- Yanes, Arianna F., Alexandra Weil, Karina C. Furlan, Emily Poon, and Murad Alam. 2018. “Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision”. JAMA Dermatology. American Medical Association (AMA). doi:10.1001/jamadermatol.2018.1783.
- Kwon, Whi-An, Jae Whan Lee, Ho Kyung Seo, Tae Hoon Oh, Seung Chol Park, Hee Jong Jeong, and Ill Young Seo. 2017. “Hand-holding During Cystoscopy Decreases Patient Anxiety, Pain, and Dissatisfaction: A Pilot Randomized Controlled Trial”. Urologia Internationalis. S. Karger AG. doi:10.1159/000485745.
- 2021. "Hand Holding During Light Sedation for Minimally Invasive Spine Surgery Improves Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05058079.
Frequently Asked Questions
Who meets the requirements to enroll in this clinical trial?
"This study is seeking around 154 patients that have a spine injury and are aged between 18-80." - Anonymous Online Contributor
Would this experiment still be beneficial for individuals above the age of 20?
"The adults-only policy for this clinical trial sets the minimum age of participants at 18 and the maximum age limit at 80 years old." - Anonymous Online Contributor
Are we able to still enroll patients in this research?
"The study is ongoing and looking for participants. According to the information on clinicaltrials.gov, the trial was posted on September 20th, 2021 and last updated September 16th, 2021." - Anonymous Online Contributor
How many people have been recruited for this research project?
"That is correct. As seen on clinicaltrials.gov, this study was originally posted on September 20th, 2021 and is currently looking for 154 patients from 1 site." - Anonymous Online Contributor