## Protocol Section
### Identification Module
**NCT ID:** NCT05058079

**Acronym:** HHLS

**Brief Title:** Hand Holding During Light Sedation for Minimally Invasive Spine Surgery Improves Outcomes

**Official Title:** The Effect of Hand Holding on Patient Satisfaction During for Minimally Invasive Spine Surgery Under Monitored Anesthesia Care. A Single Blinded, Single Center Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 1678933
#### Organization
**Class:** OTHER
**Full Name:** Rhode Island Hospital
### Status Module
#### Completion Date
**Date:** 2022-12-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-09-27

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-16

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09-20

**Type:** ESTIMATED

**Status Verified Date:** 2021-09

#### Study First Post Date
**Date:** 2021-09-27
**Type:** ACTUAL
**Study First Submit Date:** 2021-09-02
**Study First Submit QC Date:** 2021-09-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Rhode Island Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Minimally invasive spine interventions have emerged as a treatment options for patients with previous spine surgery and patients who have never before been operated upon. These procedures can be done safely in patients with advanced comorbid conditions, previous failed major spine procedures, and in patients who have decided to try the least invasive approach to address their lumbo-sacral spine condition in hopes of avoiding more major and potentially morbid procedures. These endoscopic procedures are typically done as outpatients with light sedation, ideally rendering the patient calm but completely cooperative and able to respond in real-time to questions from the surgeon during the procedure. This has implications for the progress and success of the procedure, the safety of the procedure and allows for a short ambulatory hospital stay.

Hand holding has been shown to improve outcomes such as compliance, procedural success and patient comfort with patients undergoing light sedation for a variety of procedures. The purpose of this study is to determine whether adding hand holding to light sedation for minimally invasive spine procedures has a positive impact on patient satisfaction and perioperative outcomes.

### Conditions Module

**Conditions:**

- Spine

- Minimally Invasive

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- CARE_PROVIDER

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 154

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Intraoperative Hand Held

**Label:** Hand-held group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Label:** No hand holding group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hand-held group

**Description:** Intraoperative hand holding

**Name:** Intraoperative Hand Held

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Iowa Satisfaction with Anesthesia Scale (ISAS)

**Time Frame:** 24 hours after the procedure

#### Secondary Outcomes

**Description:** Numerical pain score (0=no pain, 10=worst pain imaginable)

**Measure:** Pain Score

**Time Frame:** Through study completion up to 24 hours after procedure.

**Description:** The 6-item version of the Spielberger 20-item State-Trait Anxiety Inventory (STAI) is a validated short form and correlates well with the standard inventory. It measures state anxiety (how one feels at the moment: "feel questions") and trait anxiety (how one generally feels: "am questions"). It contains six questions with a Likert scale from 1 to 4 (1=not at all, 2=somewhat, 3=moderately so, 4=very much so) The score range is from a minimum of 6 to a maximum of 24. A low score represents no to low anxiety where as a high score represents high anxiety.

**Measure:** State Trait Anxiety Inventory (STAI)

**Time Frame:** Before and 24 hours after the procedure

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jcaiati@lifespan.org

**Name:** Joseph Caiati, MD

**Phone:** 401-444-5172

**Role:** CONTACT

**Contact 2:**

**Email:** mark.kendall@lifespan.org

**Name:** Mark Kendall, MD

**Phone:** 401-444-4722

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Providence

**Contacts:**

***Contact 1:***

- **Email:** mark.kendall@lifespan.org

- **Name:** Mark Kendall, MD

- **Phone:** 401-444-4722

- **Role:** CONTACT

***Contact 2:***

- **Name:** Albert Telfeian, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Rhode Island Hospital

**State:** Rhode Island

**Status:** RECRUITING

**Zip:** 02903

#### Overall Officials

**Official 1:**

**Affiliation:** Rhode Island Hospital

**Name:** Joseph Caiati, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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:** 29275402

**Citation:** 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:** 21519043

**Citation:** 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:** 30027283

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
