ParkinsonNCT06154772
Quality of Life, Anxiety and Fatigue Level of Parkison's Patients With Color Therapy
A study testing Color Therapy in people with Parkinson, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson
- What is being tested?
- Color Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Parkinson patients who did not agree to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson
- Being tested
- Color Therapy
- Keywords
- Color therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color TherapyOther
Color therapy will be applied to the body chakras for 10-15 minutes with colored fabrics, color therapy with water and colored light lamp.
| Study group | Role | What they receive |
|---|---|---|
| Color Therapy | Experimental | Balancing body chakras with colors. Colors are applied to the body's chakras for 10-15 minutes. Receives: Other: Color Therapy |
| Control Group | No intervention | Routine maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale (SF36)
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.
Measured: At the end of Color Therapy (therapy 9 times in total in 3 months)
Beck Anxiety Inventory (BAI)
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.
Measured: At the end of Color Therapy (therapy 9 times in total in 3 months)
Parkinson's Fatigue Scale (PYO-16)
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.
Measured: At the end of Color Therapy (therapy 9 times in total in 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Nov 2023
- Primary completion27 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an experimental study with pre-test and post-test control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154772
- Sponsor's protocol ID
- 27/09/2023
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Color Therapy on Quality of Life, Anxiety and Fatigue Levels of Parkison Patients
- ClinicalTrials.gov ID
- NCT06154772
- Acronym / sponsor ID
- 27/09/2023
- Conditions
- Parkinson
- Keywords
- Color therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 27 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an experimental study with pre-test and post-test control groups
| Arm | Type | Receives |
|---|---|---|
| Color Therapy | Experimental | Other: Color TherapyBalancing body chakras with colors. Colors are applied to the body's chakras for 10-15 minutes. |
| Control Group | No intervention | –Routine maintenance will be applied |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Parkinson patients who did not agree to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Color TherapyColor therapy will be applied to the body chakras for 10-15 minutes with colored fabrics, color therapy with water and colored light lamp. | Other | Color Therapy |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Color Therapy in people with Parkinson, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Scale (SF36) (time frame: At the end of Color Therapy (therapy 9 times in total in 3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.