- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03992586
Effect of Rose-colored Glass on Mood
August 21, 2020 updated by: Florida Center for Dermatology
Effect of Rose-colored Glass on Mood: A Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32204
- St Vincent's Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- Subjects over 18 years of age.
Exclusion Criteria:
- Subjects who wear glasses on a regular basis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pink lenses
Pink-colored lenses
|
Wearing pink-colored lenses
|
|
Placebo Comparator: Clear lenses
|
Wearing clear glasses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Anxiety Scores on the Visual Analogue Scale at 1 week
Time Frame: 1 week
|
Scale range 0-100, higher values represent more anxiety
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Mood Scores on the Visual Analogue Scale
Time Frame: 1 week
|
Scale range 0-100, higher values represent more sadness
|
1 week
|
|
Change from baseline in Happiness Scores on the Visual Analogue Scale
Time Frame: 1 week
|
Scale range 0-100, higher values represent more happiness
|
1 week
|
|
Change from baseline in the Center for Epidemiological Studies Depression Scale score
Time Frame: 1 week
|
Scale range 0-60, higher values suggest more depressive symptoms
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Kantor, MD, Florida Center for Dermatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2018
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
August 14, 2018
First Submitted That Met QC Criteria
June 18, 2019
First Posted (Actual)
June 20, 2019
Study Record Updates
Last Update Posted (Actual)
August 25, 2020
Last Update Submitted That Met QC Criteria
August 21, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- RCG101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized data are available to other researchers upon reasonable request.
IPD Sharing Time Frame
Data are available to other researchers upon reasonable request.
IPD Sharing Access Criteria
Data are available to other researchers upon reasonable request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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