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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Carpal Tunnel Syndrome; Anxiety; Engagement, Patient; Trigger Finger
• Intervention / Treatment: Other: High-quality, physician created video; Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital, Schwartz Ambulatory Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Video group; 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.	Other: High-quality, physician created video; 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).
PLACEBO_COMPARATOR: Control group; Patients selected to be in the control group will not be asked to watch a video prior to surgery.	Other: Standard of care; Patients in the control group will not be asked to do anything differently prior to their surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Immediately prior to surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	Immediately before surgery
Pain catastrophizing	As determined by the pain catastrophizing scale (PCS); (minimum score: 0, maximum score: 100, higher scores indicate more anxiety)	Immediately before surgery
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)	Immediately before surgery
Pain scores	Assessed by Visual Analog Scale (VAS) pain scores (minimum: 0, maximum: 10, higher scores indicate greater levels of pain)	At 48-72 hour post-operatively and 2 weeks post-operatively
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)	At 48-72 hour post-operatively and 2 weeks post-operatively

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): July 1, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Tendinopathy; Tendon Entrapment; Carpal Tunnel Syndrome; Anxiety Disorders; Trigger Finger Disorder
• Other Study ID Numbers: 20-0516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No