NCT04424810

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

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

June 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

June 3, 2020

Last Update Submit

September 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Percentage of patients who sought out pre-operative videos before surgery

    Immediately before surgery

  • Pain catastrophizing

    Immediately before surgery

  • Patient engagement

    Immediately before surgery

  • Pain scores

    At 48-72 hour post-operatively and 2 weeks post-operatively

  • Functional outcomes

    At 48-72 hour post-operatively and 2 weeks post-operatively

Study Arms (2)

Video group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Other: Standard of care

Interventions

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).

Video group

Patients in the control group will not be asked to do anything differently prior to their surgery

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore University Hospital, Schwartz Ambulatory Surgery Center

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Anxiety DisordersCarpal Tunnel SyndromeTrigger Finger DisorderPatient ParticipationPain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental DisordersMedian NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesTendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel, 2 groups, 1:1 randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician, Department of Orthopaedic Surgery

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 11, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations