Effect of Rose-colored Glass on Mood | NCT03992586

Studies
Effect of Rose-colored Glass on Mood

NCT03992586

Sponsor

Florida Center for Dermatology

Status

Completed

Last Update Posted

Aug 25, 2020Actual

Enrollment

38Actual

Phase

Not Applicable

Conditions

Mood

Interventions

Wearing pink glasses
Wearing clear glasses

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2018Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Aug 14, 2018

First Submission Date that Met QC Criteria

Jun 18, 2019

First Posted Date

Jun 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2020

Last Update Posted Date

Aug 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Decades of psychological research has highlighted the impact of visual perception on mood and happiness. The investigators hypothesized that literally seeing the world through rose colored glasses may have an effect on perception, mood, and happiness. After cataract surgery, which classically increases the vividness of perceived colors, patients report significant satisfaction. The investigators therefore sought to explore whether using pink colored lenses leads to a measurable impact on outcomes.

Detailed Description

A randomized controlled clinical trial design will be performed. Subjects will be randomized for either pink lenses (treatment group) or clear lenses (placebo group).

Subjects will be asked to wear the assigned glasses throughout the day during the course of the trial. Glasses will not be work while driving at night.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pink lenses	Experimental	Pink-colored lenses	Other: Wearing pink glasses
Clear lenses	Placebo Comparator	Clear lenses	Other: Wearing clear glasses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wearing pink glasses	Other	Wearing pink-colored lenses	Pink lenses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Anxiety Scores on the Visual Analogue Scale at 1 week	Scale range 0-100, higher values represent more anxiety	1 week

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in Mood Scores on the Visual Analogue Scale	Scale range 0-100, higher values represent more sadness	1 week
Change from baseline in Happiness Scores on the Visual Analogue Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects over 18 years of age.

Exclusion Criteria:

Subjects who wear glasses on a regular basis.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan Kantor, MD	Florida Center for Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Vincent's Medical Center		Jacksonville	Florida	32204	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized data are available to other researchers upon reasonable request.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Data are available to other researchers upon reasonable request.

Access Criteria

Data are available to other researchers upon reasonable request.

URL

Not provided