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Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery

Primary Purpose

Anxiety, Carpal Tunnel Syndrome, Trigger Finger

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-quality, physician created video
Standard of care
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • undergoing a primary routine elective hand procedure (Carpal tunnel release, trigger finger release)
  • age > 18 years

Exclusion Criteria:

  • revision procedure
  • prior debilitating upper extremity injury
  • surgery not being performed on ambulatory basis
  • special populations (pregnant patients, prisoners or other institutionalized patients, cognitive impairment)
  • non-english speaking patients (videos only available in english language)
  • age < 18 years

Sites / Locations

  • North Shore University Hospital, Schwartz Ambulatory Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Video group

Control group

Arm Description

Patients selected to be in the intervention group will be asked to watch a high-quality, physician created video describing their condition and the operative treatment they are about to undergo.

Patients selected to be in the control group will not be asked to watch a video prior to surgery.

Outcomes

Primary Outcome Measures

Pre-operative anxiety
We will measure pre-operative anxiety using the State-Trait Anxiety Inventory (STAI) 6-item short form (minimum score: 20, maximum score: 80, higher scores indicate more anxiety)

Secondary Outcome Measures

Percentage of patients who sought out pre-operative videos before surgery
We plan to determine the percentage of patients who sought out pre-operative videos before surgery on websites such as YouTube as a part of our "video questionnaire"
Pain catastrophizing
As determined by the pain catastrophizing scale (PCS); (minimum score: 0, maximum score: 100, higher scores indicate more anxiety)
Patient engagement
To determine patient levels of engagement in their care as assessed by the Patient Activation Measure (PAM)-13 (minimum score: 0, maximum score: 100, higher scores indicate higher levels of activation/engagement in care)
Pain scores
Assessed by Visual Analog Scale (VAS) pain scores (minimum: 0, maximum: 10, higher scores indicate greater levels of pain)
Functional outcomes
Assessed by the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire (minimum: 0, maximum: 100, greater scores indicate a greater level of disability)

Full Information

First Posted
June 3, 2020
Last Updated
September 2, 2021
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04424810
Brief Title
Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery
Official Title
Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Previous research has shown that YouTube is a poor source of high-quality medical information. This is likely because there is no regulation of the content on YouTube and relatively little of the content is posted by qualified medical professionals. It is known that up to 30% of patients use the internet to research the procedure they will be having and given the increasing popularity of YouTube we suspect many patients are using YouTube or similar sites as a source of information prior to elective surgery. There are likely a number of patient factors that contribute to patients seeking out videos as a source of pre-operative medical information. Patient age, which is generally inversely correlated to computer literacy, may have a role. Patient anxiety and pre-operative worrying may cause a patient to turn to the internet to search for information, and the poor overall quality of the content available may worsen pre-operative anxiety. The primary objective of this study is to determine if providing patients with a reliable, high-quality video about their condition and operation prior to surgery reduces pre-operative anxiety. Secondary aims are to determine the percentage of patients that independently seek out videos online as a source of medical information prior to elective hand surgery, identify patient attributes that are associated with this behavior, and understand if introducing high quality pre-surgical videos has an impact on post-operative patient outcomes and/or patient engagement. The investigators hypothesize that providing patients with high-quality pre-operative videos will reduce pre-operative anxiety. Its is also expected that patients who seek out videos on their own for pre-operative medical information will be younger and have higher anxiety levels and pain catastrophizing scores. Additionally, the investigators hypothesize that patients who watch high-quality pre-operative videos may have better short term post-operative outcomes and greater engagement in their care than their counterparts that did not watch videos or who sought out videos on their own.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Carpal Tunnel Syndrome, Trigger Finger, Engagement, Patient, Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel, 2 groups, 1:1 randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video group
Arm Type
Experimental
Arm Description
Patients selected to be in the intervention group will be asked to watch a high-quality, physician created video describing their condition and the operative treatment they are about to undergo.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients selected to be in the control group will not be asked to watch a video prior to surgery.
Intervention Type
Other
Intervention Name(s)
High-quality, physician created video
Intervention Description
The intervention group will watch a short (2-5 minute) video prior to surgery that will provide them with information about their condition and the procedure they are about to undergo (either carpal tunnel release or trigger finger release).
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Patients in the control group will not be asked to do anything differently prior to their surgery
Primary Outcome Measure Information:
Title
Pre-operative anxiety
Description
We will measure pre-operative anxiety using the State-Trait Anxiety Inventory (STAI) 6-item short form (minimum score: 20, maximum score: 80, higher scores indicate more anxiety)
Time Frame
Immediately prior to surgery
Secondary Outcome Measure Information:
Title
Percentage of patients who sought out pre-operative videos before surgery
Description
We plan to determine the percentage of patients who sought out pre-operative videos before surgery on websites such as YouTube as a part of our "video questionnaire"
Time Frame
Immediately before surgery
Title
Pain catastrophizing
Description
As determined by the pain catastrophizing scale (PCS); (minimum score: 0, maximum score: 100, higher scores indicate more anxiety)
Time Frame
Immediately before surgery
Title
Patient engagement
Description
To determine patient levels of engagement in their care as assessed by the Patient Activation Measure (PAM)-13 (minimum score: 0, maximum score: 100, higher scores indicate higher levels of activation/engagement in care)
Time Frame
Immediately before surgery
Title
Pain scores
Description
Assessed by Visual Analog Scale (VAS) pain scores (minimum: 0, maximum: 10, higher scores indicate greater levels of pain)
Time Frame
At 48-72 hour post-operatively and 2 weeks post-operatively
Title
Functional outcomes
Description
Assessed by the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire (minimum: 0, maximum: 100, greater scores indicate a greater level of disability)
Time Frame
At 48-72 hour post-operatively and 2 weeks post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: undergoing a primary routine elective hand procedure (Carpal tunnel release, trigger finger release) age > 18 years Exclusion Criteria: revision procedure prior debilitating upper extremity injury surgery not being performed on ambulatory basis special populations (pregnant patients, prisoners or other institutionalized patients, cognitive impairment) non-english speaking patients (videos only available in english language) age < 18 years
Facility Information:
Facility Name
North Shore University Hospital, Schwartz Ambulatory Surgery Center
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery

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