NCT05058079

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

September 2, 2021

Last Update Submit

September 16, 2021

Conditions

SpineMinimally Invasive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pain Score

    Through study completion up to 24 hours after procedure.

  • State Trait Anxiety Inventory (STAI)

    Before and 24 hours after the procedure

Study Arms (2)

Hand-held group

ACTIVE COMPARATOR

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.

Behavioral: Intraoperative Hand Held

No hand holding group

NO 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.

Interventions

Intraoperative Hand HeldBEHAVIORAL

Intraoperative hand holding

Hand-held group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiology physical status 1 to 3
  • Outpatient endoscopic spine procedures under light sedation

You may not qualify if:

  • American Society of Anesthesiology physical status 4 or greater
  • Pre-existing neuropathy
  • Infection at the site
  • Pregnancy
  • Patient's refusal or inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29275402BACKGROUND

  • 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.

    PMID: 21519043BACKGROUND

  • 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.

    PMID: 30027283BACKGROUND

Study Officials

  • Joseph Caiati, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Caiati, MD

CONTACT

401-444-5172jcaiati@lifespan.org

Mark Kendall, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 27, 2021

Study Start

September 20, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)