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

Sponsor
Northwell Health (Other)
Overall Status
Completed
CT.gov ID
NCT04424810
Collaborator
(none)
167
1
2
12
13.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High-quality, physician created video
  • Other: Standard of care
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
167 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel, 2 groups, 1:1 randomizationParallel, 2 groups, 1:1 randomization
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery
Actual Study Start Date :
Jul 1, 2020
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pre-operative anxiety [Immediately prior to surgery]

    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

  1. Percentage of patients who sought out pre-operative videos before surgery [Immediately 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"

  2. Pain catastrophizing [Immediately before surgery]

    As determined by the pain catastrophizing scale (PCS); (minimum score: 0, maximum score: 100, higher scores indicate more anxiety)

  3. Patient engagement [Immediately before surgery]

    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)

  4. Pain scores [At 48-72 hour post-operatively and 2 weeks post-operatively]

    Assessed by Visual Analog Scale (VAS) pain scores (minimum: 0, maximum: 10, higher scores indicate greater levels of pain)

  5. Functional outcomes [At 48-72 hour post-operatively and 2 weeks post-operatively]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 North Shore University Hospital, Schwartz Ambulatory Surgery Center Manhasset New York United States 11030

Sponsors and Collaborators

  • Northwell Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher Larsen, Physician, Department of Orthopaedic Surgery, Northwell Health
ClinicalTrials.gov Identifier:
NCT04424810
Other Study ID Numbers:
  • 20-0516
First Posted:
Jun 11, 2020
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021