NCT06154772

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 24, 2023

Last Update Submit

November 21, 2024

Conditions

Keywords

Color therapy

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    At the end of Color Therapy (therapy 9 times in total in 3 months)

Study Arms (2)

Color Therapy

EXPERIMENTAL

Balancing body chakras with colors. Colors are applied to the body's chakras for 10-15 minutes.

Other: Color Therapy

Control Group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Color therapy will be applied to the body chakras for 10-15 minutes with colored fabrics, color therapy with water and colored light lamp.

Color Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Parkinson patients who did not agree to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat University

Elâzığ, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Color Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPhototherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an experimental study with pre-test and post-test control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 4, 2023

Study Start

November 1, 2023

Primary Completion

April 27, 2024

Study Completion

June 30, 2024

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations