Hand-held group for Spine

Phase-Based Progress Estimates
Rhode Island Hospital, Providence, RISpine+1 MoreIntraoperative Hand Held - Behavioral
18 - 80
All Sexes
What conditions do you have?

Study 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
  • Minimally Invasive Surgery
  • Spine

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Through study completion up to 24 hours after procedure.

Hour 24
Iowa Satisfaction with Anesthesia Scale (ISAS)
Hour 24
State Trait Anxiety Inventory (STAI)
Hour 24
Pain Score

Trial Safety

Trial Design

2 Treatment Groups

Hand-held group
1 of 2
No hand holding group
1 of 2

Active Control

154 Total Participants · 2 Treatment Groups

Primary Treatment: Hand-held group · No Placebo Group · N/A

Hand-held group
ActiveComparator Group · 1 Intervention: Intraoperative Hand Held · Intervention Types: Behavioral
No hand holding groupNoIntervention Group · 1 Intervention: No hand holding group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion up to 24 hours after procedure.

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
241 Previous Clinical Trials
59,051 Total Patients Enrolled
Joseph Caiati, MDPrincipal InvestigatorRhode Island Hospital

Eligibility Criteria

Age 18 - 80 · All Participants · 2 Total Inclusion Criteria

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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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.