Recruiting

Hand Holding

Sponsor:

Rhode Island Hospital

Code:

NCT05058079

Conditions

Spine

Minimally Invasive

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intraoperative Hand Held

Study Details

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.

Conditions

Spine

Minimally Invasive

Study ID

NCT05058079

Start date

Sep 20, 2021

Status verified date

Sep, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

154 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Hand-held group

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.

no intervention: No hand holding group

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.

Interventions

Intraoperative Hand Held

Intraoperative hand holding

Primary outcome measure

  • Iowa Satisfaction with Anesthesia Scale (ISAS) [ Time Frame: 24 hours after the procedure ]

Central Contacts and Locations

Central contacts

Joseph Caiati, MD

401-444-5172jcaiati@lifespan.org

Mark Kendall, MD

401-444-4722mark.kendall@lifespan.org

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Mark Kendall, MD

401-444-4722mark.kendall@lifespan.org

More Information

Sponsor

Rhode Island Hospital

Last update posted

Sep 27, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2021-09-27.