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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Elazıg, Turkey
        • Firat University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Color Therapy
Balancing body chakras with colors. Colors are applied to the body's chakras for 10-15 minutes.
Other: Color Therapy
Color therapy will be applied to the body chakras for 10-15 minutes with colored fabrics, color therapy with water and colored light lamp.
No Intervention: Control Group
Routine maintenance will be applied

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
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.
At the end of Color Therapy (therapy 9 times in total in 3 months)
Beck Anxiety Inventory (BAI)
Time Frame: At the end of Color Therapy (therapy 9 times in total in 3 months)
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.
At the end of Color Therapy (therapy 9 times in total in 3 months)
Parkinson's Fatigue Scale (PYO-16)
Time Frame: At the end of Color Therapy (therapy 9 times in total in 3 months)
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.
At the end of Color Therapy (therapy 9 times in total in 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27/09/2023

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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