- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06879808
The Effect of Color Therapy on Depression, Stress, Anxiety and Quality of Life in Hemodialysis Patients: A Randomized Controlled Study (Color Therapy)
March 11, 2025 updated by: Safiye Yanmış, Erzincan Binali Yildirim Universitesi
This study was conducted to examine the effect of color therapy on depression, stress, anxiety and quality of life in hemodialysis patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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
-
-
Merkez
-
Elazığ, Merkez, Turkey, 23119
- Fırat 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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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 group
group doing color therapy
|
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.
|
|
No Intervention: No color therapy group
group not doing color therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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".
|
8 week
|
|
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
|
8 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gülcan Bahçecioğlu Turan, Associate Professor, Firat University
- Study Director: Zülfünaz Özer, Associate Professor, Istanbul Sebahattin Zaim University
- Study Director: Safiye Yanmış, Assistant Professor, Erzincan Binali Yildirim Universitesi
- Study Director: Mukadder Mollaoğlu, Professor Doctor, Cumhuriyet 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)
April 1, 2024
Primary Completion (Actual)
December 1, 2024
Study Completion (Actual)
February 1, 2025
Study Registration Dates
First Submitted
March 11, 2025
First Submitted That Met QC Criteria
March 11, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 11, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Erzi̇ncanBinaliYildirimUni
- Scientific Research Projects (Other Identifier: Istanbul Aydin University Scientific Research Projects)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
After the article is published
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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