The Effect of Color Therapy on Depression, Stress, Anxiety and Quality of Life in Hemodialysis Patients: A Randomized Controlled Study

NCT06879808 | Completed DMC

• 2 other identifiers: Erzi̇ncanBinaliYildirimUniScientific Research Projects
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to examine the effect of color therapy on depression, stress, anxiety and quality of life in hemodialysis patients.

Conditions

Hemodialysis; Color Therapy

Keywords

Anxiety; Color Therapy; Depression; Hemodialysis; Nursing; Quality of Life; Stress

Outcome Measures

Primary Outcomes (2)

• 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".

  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

  8 week

Study Arms (2)

Color therapy group

EXPERIMENTAL

group doing color therapy

Other: Color therapy

No color therapy group

NO INTERVENTION

group not doing color therapy

Interventions

Color therapy OTHER

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.

Color therapy group

Eligibility Criteria

• Age: 18 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erzincan Binali Yildirim Universitesi: lead

Study Sites (1)

Fırat University

Elâzığ, Merkez, 23119, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Color Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Phototherapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gülcan Bahçecioğlu Turan, Associate Professor

  Firat University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)