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Hand-held group for Spine (HHLS Trial)

N/A

Waitlist Available

Led By Joseph Caiati, MD

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and 24 hours after the procedure

Awards & highlights

HHLS Trial Summary

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.

Eligible Conditions

Spine
Minimally Invasive Surgery

HHLS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Iowa Satisfaction with Anesthesia Scale (ISAS)

Secondary outcome measures

Pain Score

State Trait Anxiety Inventory (STAI)

HHLS Trial Design

2Treatment groups

Active Control

Group I: No hand holding groupActive Control1 Intervention

No physical contact for comfort or reassurance during the procedure. A folded blanket will be over the patient's hand during the procedure and the anesthesia provider will be next to the patient's hand.

Group II: Hand-held groupActive Control1 Intervention

Patients hand will be held by the anesthesia provider during the procedure. A folded blanket will be over the patient's hand during the procedure and the anesthesia provider will have their hand under the folded blanket holding the patient's hand.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

71,580 Total Patients Enrolled

Joseph Caiati, MDPrincipal InvestigatorRhode Island Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

Anesthesia & AnalgesiaJournal

Multicenter Assessment of the Iowa Satisfaction with Anesthesia Scale, an Instrument That Measures Patient Satisfaction with Monitored Anesthesia Care

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.

JAMA DermatologyJournal

Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision

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.

Urologia InternationalisJournal

Hand-holding During Cystoscopy Decreases Patient Anxiety, Pain, and Dissatisfaction: A Pilot Randomized Controlled Trial

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.

clinicaltrials.govStudy