- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06154772
Quality of Life, Anxiety and Fatigue Level of Parkison's Patients With Color Therapy
November 21, 2024 updated by: Gülcan Bahçecioğlu Turan, Ataturk University
The Effect of Color Therapy on Quality of Life, Anxiety and Fatigue Levels of Parkison Patients
The aim of this study was to investigate the effect of color therapy on quality of life, anxiety and fatigue levels in patients with Parkinson's disease.
Study Overview
Detailed Description
Color Therapy aims to balance and heal our body's energy centers using the seven color spectrum, which helps to promote our body's own healing process.
Thus good health and well-being is achieved through the balance of all these energies.
Color therapy basically consists of color and character analysis with name, color therapy with chakras, programming of the pendulum, chakras and color application, color application with water, color application with colored light device.
Study Type
Interventional
Enrollment (Actual)
60
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
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-
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Elazıg, Turkey
- Firat University
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having been diagnosed with Parkinson's disease for at least 6 months,
- Those who have not taken sleeping pills or sedative drugs,
- Not having undergone brain stimulation surgery,
- Do not have a physical illness or cognitive disability that would prevent them from understanding the education provided, and do not have a diagnosis of a psychiatric disease,
- According to the Parkinson's Fatigue Scale, the scale score is >8
- The patient or someone living in the same house with the patient is literate,
- Patients have no vision problems.
Exclusion Criteria:
- Parkinson patients who did not agree to participate in the research
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Color Therapy
Balancing body chakras with colors.
Colors are applied to the body's chakras for 10-15 minutes.
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Color therapy will be applied to the body chakras for 10-15 minutes with colored fabrics, color therapy with water and colored light lamp.
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No Intervention: Control Group
Routine maintenance will be applied
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life Scale (SF36)
Time Frame: At the end of Color Therapy (therapy 9 times in total in 3 months)
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It was developed to measure the quality of life in people with physical diseases.
It is measured in 8 dimensions and 36 items: physical function, physical role difficulty, emotional role difficulty, viability, mental health, social functionality, pain, and general health perception.
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At the end of Color Therapy (therapy 9 times in total in 3 months)
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Beck Anxiety Inventory (BAI)
Time Frame: At the end of Color Therapy (therapy 9 times in total in 3 months)
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It consists of 21 questions and a minimum score of 0 and a maximum score of 3 is obtained from each question.
As a result of the answers to all questions, all answers are summed up and a total score is obtained.
In the evaluation phase, the presence and level of depression is interpreted in line with the meanings expressed by the score ranges.
In the evaluation, 0-9 point range defines the presence of minimal depressive symptoms, 10-16 point range defines the presence of mild depressive symptoms, 17-29 point range defines the presence of moderate depressive symptoms and 30-63 point range defines the presence of severe depressive symptoms.
A score of 17 and above indicates a level of depression that may require treatment.
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At the end of Color Therapy (therapy 9 times in total in 3 months)
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Parkinson's Fatigue Scale (PYO-16)
Time Frame: At the end of Color Therapy (therapy 9 times in total in 3 months)
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It consists of 16 items, with 5 responses for each item (1=strongly disagree, 5=strongly agree).
The result evaluation can be done in two different ways.
The total value is calculated as the average of the response to all items (value range 1-5).
Scores above the average "3.3" are considered tired.
In the other rating option, 0 (actual response 1-3) and 1 (actual response 4-5) are scored, with a total value between 0-16.
A total of 8 points and above is considered tired.
In both methods, a higher value indicates a higher level of fatigue.
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At the end of Color Therapy (therapy 9 times in total in 3 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 1, 2023
Primary Completion (Actual)
April 27, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
November 24, 2023
First Submitted That Met QC Criteria
November 24, 2023
First Posted (Actual)
December 4, 2023
Study Record Updates
Last Update Posted (Estimated)
November 25, 2024
Last Update Submitted That Met QC Criteria
November 21, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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