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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424810
• Other study ID #: 20-0516
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Carpal Tunnel Syndrome
• Engagement, Patient
• Pain
• Trigger Finger
• Trigger Finger Disorder

Intervention

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).
• Standard of care
Patients in the control group will not be asked to do anything differently prior to their surgery

Locations

Country	Name	City	State
United States	North Shore University Hospital, Schwartz Ambulatory Surgery Center	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pain catastrophizing	As determined by the pain catastrophizing scale (PCS); (minimum score: 0, maximum score: 100, higher scores indicate more anxiety)	Immediately before surgery
Secondary	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
Secondary	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
Secondary	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