HemodialysisColor TherapyNCT06879808
The Effect of Color Therapy on Depression, Stress, Anxiety and Quality of Life in Hemodialysis Patients: A Randomized Controlled Study
A study testing Color therapy in people with Hemodialysis and Color Therapy, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to examine the effect of color therapy on depression, stress, anxiety and quality of life in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 weeks and older
- Conditions the study is for
- Hemodialysis, Color Therapy
- 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 Apr 2024to 1 Feb 2025
- 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 18 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be on hemodialysis treatment for at least 6 months,
- No sleeping pills or sedative medication,
- No physical or cognitive impairment that prevents them from understanding the education and no diagnosis of a psychiatric illness,
- The patient or someone living in the same household with the patient is literate,
- Patients have no vision problems,
- Patients must be 18 years of age or older.
Who cannot join
- Being on hemodialysis treatment for less than 6 months,
- Taking sleeping pills or sedative medication,
- Being diagnosed with a physical illness or cognitive impairment or psychiatric illness that prevents understanding the education provided,
- Illiteracy of the patient and relatives,
- Patients have vision problems,
- Refusing to participate in the research,
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to examine the effect of color therapy on depression, stress, anxiety and quality of life in hemodialysis patients.
Read the detailed description
Many patients on hemodialysis treatment require hemodialysis, which requires hospitalization three times a week for four hours each dialysis session. Therefore, practices such as color therapy may be useful in the management of psychological symptoms in these patients.
- Conditions
- Hemodialysis, Color Therapy
- Being tested
- Color therapy
- Keywords
- Anxiety, Color Therapy, Depression, Hemodialysis, Nursing, Quality of Life, Stress
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color therapyOther
In the experimental group, color therapy was applied 3 days a week for the first two weeks, while no intervention was performed in the third and fourth weeks. In the fifth and seventh weeks, color therapy was applied for 15 minutes each day, while no intervention was performed in the sixth week.
| Study group | Role | What they receive |
|---|---|---|
| Color therapy group | Experimental | group doing color therapy Receives: Other: Color therapy |
| No color therapy group | No intervention | group not doing color therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress-21 scale (DASS-21)
The 21-question DASS scale used in the study was taken by Henry and Crawford. This scale (DASS-21) has 7 questions each to measure the dimensions of depression, stress and anxiety. The scale is a 4-point Likert-type scale, coded as 0 "not applicable to me", 1 "somewhat applicable to me", 2 "generally applicable to me", and 3 "completely applicable to me".
Measured: 8 week
Short Form-12 (SF-12) Quality of Life Scale
Ware et al. decided to develop a more practical form of the SF-36 that could be administered in a shorter time and developed the SF-12, which contains the same sub-dimensions as the SF-36 by reducing the number of questions. In addition to the fact that the SF-12 was created in such a way that the same component summary scores can be obtained as the SF-36, the fact that it contains fewer items and therefore has a shorter administration time provides a great advantage. Although it has been demonstrated that the SF-36 scale has sufficient validity and reliability in studies conducted in both patient and normal sample groups in our country, the validity and reliability study of the Turkish form of the SF-12, which was developed as a shorter alternative to the SF-36, was attempted. Similar to SF-36, SF-12 consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social function
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Apr 2024
- Primary completion1 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- 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
- Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safiye Yanmış, Erzincan Binali Yildirim Universitesi
- Investigators
- Gülcan Bahçecioğlu Turan, Associate Professor, Principal investigator, Firat UniversityZülfünaz Özer, Associate Professor, Study director, Istanbul Sebahattin Zaim UniversitySafiye Yanmış, Assistant Professor, Study director, Erzincan Binali Yildirim UniversitesiMukadder Mollaoğlu, Professor Doctor, Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879808
- Sponsor's protocol ID
- Erzi̇ncanBinaliYildirimUni
- Other IDs
- Scientific Research Projects
- Acronym
- Color Therapy
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the article is published
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Color Therapy on Depression, Stress, Anxiety and Quality of Life in Hemodialysis Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06879808
- Acronym / sponsor ID
- Color Therapy / Erzi̇ncanBinaliYildirimUni
- Conditions
- Hemodialysis, Color Therapy
- Keywords
- Anxiety, Color Therapy, Depression, Hemodialysis, Nursing, Quality of Life, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 17 Mar 2025 (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.
This study was conducted to examine the effect of color therapy on depression, stress, anxiety and quality of life in hemodialysis patients.
Detailed description
Many patients on hemodialysis treatment require hemodialysis, which requires hospitalization three times a week for four hours each dialysis session. Therefore, practices such as color therapy may be useful in the management of psychological symptoms in these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Color therapy group | Experimental | Other: Color therapygroup doing color therapy |
| No color therapy group | No intervention | –group not doing color therapy |
Who may qualify
- Ages
- 18 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Be on hemodialysis treatment for at least 6 months,
- No sleeping pills or sedative medication,
- No physical or cognitive impairment that prevents them from understanding the education and no diagnosis of a psychiatric illness,
- The patient or someone living in the same household with the patient is literate,
- Patients have no vision problems,
Key exclusion criteria (7 listed)
- Being on hemodialysis treatment for less than 6 months,
- Taking sleeping pills or sedative medication,
- Being diagnosed with a physical illness or cognitive impairment or psychiatric illness that prevents understanding the education provided,
- Illiteracy of the patient and relatives,
- Patients have vision problems,
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 therapyIn the experimental group, color therapy was applied 3 days a week for the first two weeks, while no intervention was performed in the third and fourth weeks. In the fifth and seventh weeks, color therapy was applied for 15 minutes each day, while no intervention was performed in the sixth week. | Other | Color therapy group |
Primary outcome
Depression Anxiety Stress-21 scale (DASS-21)
Time frame: 8 week
The 21-question DASS scale used in the study was taken by Henry and Crawford. This scale (DASS-21) has 7 questions each to measure the dimensions of depression, stress and anxiety. The scale is a 4-point Likert-type scale, coded as 0 "not applicable to me", 1 "somewhat applicable to me", 2 "generally applicable to me", and 3 "completely applicable to me".
Short Form-12 (SF-12) Quality of Life Scale
Time frame: 8 week
Ware et al. decided to develop a more practical form of the SF-36 that could be administered in a shorter time and developed the SF-12, which contains the same sub-dimensions as the SF-36 by reducing the number of questions. In addition to the fact that the SF-12 was created in such a way that the same component summary scores can be obtained as the SF-36, the fact that it contains fewer items and therefore has a shorter administration time provides a great advantage. Although it has been demonstrated that the SF-36 scale has sufficient validity and reliability in studies conducted in both patient and normal sample groups in our country, the validity and reliability study of the Turkish form of the SF-12, which was developed as a shorter alternative to the SF-36, was attempted. Similar to SF-36, SF-12 consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social function
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 17 Mar 2025.
- Individual participant dataSharing planned: No. After the article is published
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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.
Gülcan Bahçecioğlu Turan, Associate Professor principal investigator
Firat University
Zülfünaz Özer, Associate Professor study director
Istanbul Sebahattin Zaim University
Safiye Yanmış, Assistant Professor study director
Erzincan Binali Yildirim Universitesi
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 Hemodialysis and Color Therapy, run by Erzincan Binali Yildirim Universitesi 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 6 inclusion and 7 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 17 Mar 2025. 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?
Depression Anxiety Stress-21 scale (DASS-21) (time frame: 8 week). The study lists 2 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 17 Mar 2025.