NCT07005960

Brief Summary

Purpose of the Study: This study aims to investigate the effect of art therapy on anxiety and psychological resilience levels in Chronic kidney disease(CKD) patients undergoing hemodialysis patients. Hemodialysis patients undergo long-term treatment, often experiencing psychological issues such as anxiety and depression, which significantly reduce their quality of life. Among non-pharmacological approaches to alleviate these symptoms, art therapy has gained increasing attention. Art therapy helps patients shift their focus away from their illness, fosters self-confidence, reduces anxiety, and promotes relaxation .

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

May 20, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

May 20, 2025

Last Update Submit

April 16, 2026

Conditions

Keywords

Art therapyArt therapy applied to hemodialysis patientsAnxiety and Psychological Well-Being

Outcome Measures

Primary Outcomes (2)

  • State And Trait Anxiety Scale

    Measuring the change in Anxiety Levels through art therapy in patients undergoing hemodialysis treatment.

    2 months

  • Brief Psychological Resilience Scale

    Measuring the change in Psychological Resilience Levels through art therapy in patients undergoing hemodialysis treatment.

    2 months

Study Arms (2)

Art therapy experimental group

ACTIVE COMPARATOR

Patients in the experimental group will be administered the Volunteer Information and Consent Form, the Patient Information Form, the Brief Resilience Scale, and the State-Trait Anxiety Inventory prior to the intervention.

Other: Art Therapy for Anxiety in Hemodialysis PatientsOther: Art Therapy for Resilience in Hemodialysis Patients

Art therapy control group

ACTIVE COMPARATOR

For the control group (35 participants), during the first week, without any intervention beyond standard clinical procedures, participants will complete the Volunteer Information and Consent Form, the Patient Information Form, the Brief Resilience Scale, and the State-Trait Anxiety Inventory. This process will be repeated in the fourth week. One month later, the same scales will be administered again without any intervention.

Other: Art Therapy for Anxiety in Hemodialysis PatientsOther: Art Therapy for Resilience in Hemodialysis Patients

Interventions

Patients in the experimental group will be administered the Volunteer Information and Consent Form, the Patient Information Form, and the State-Trait Anxiety Inventory prior to the intervention. Then, for four weeks, the experimental group will participate in art therapy sessions involving drawing and painting for approximately 30 minutes, twice a week. In the first week, patients will be asked to paint a given picture. In the second week, they will be given a different picture to paint. In the third week, they will be asked to draw and paint a picture of their choice. In the fourth week, they will again be asked to draw and paint a picture of their choice. At the end of the fourth week, the scales will be completed again. After this, there will be a one-month break from art therapy, during which no intervention will be conducted. At the end of this month, the same scales will be administered again to the experimental group.

Art therapy control groupArt therapy experimental group

Patients in the experimental group will be administered the Volunteer Information and Consent Form, the Patient Information Form, the Brief Resilience Scale, prior to the intervention. Then, for four weeks, the experimental group will participate in art therapy sessions involving drawing and painting for approximately 30 minutes, twice a week. In the first week, patients will be asked to paint a given picture. In the second week, they will be given a different picture to paint. In the third week, they will be asked to draw and paint a picture of their choice. In the fourth week, they will again be asked to draw and paint a picture of their choice. At the end of the fourth week, the scales will be completed again. After this, there will be a one-month break from art therapy, during which no intervention will be conducted. At the end of this month, the same scales will be administered again to the experimental group.

Art therapy control groupArt therapy experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing hemodialysis for at least 6 months,
  • Willing to participate in the study,
  • Aged between 18 and 65 years,
  • No communication disorders,
  • No infectious diseases.

You may not qualify if:

  • Sensory impairments (vision or hearing loss),
  • Not willing to participate in the study,
  • Having an infectious disease.
  • Independent and Dependent Variables:
  • Independent Variable: Art therapy. Dependent Variables: Scores from the Brief Resilience Scale and State-Trait Anxiety Inventory (STAI 1-STAI 2).
  • Control Variables: Participants' sociodemographic characteristics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çeşme Alper Çizgenakat State Hospital

Izmir, 35930, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPsychological Well-Being

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sibel Olca POLAT

    sibelolca@aydın.edu.tr

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
A total of 35 participants each for the experimental and for control groups will be randomly selected
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Two groups, experimental group and control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

May 20, 2025

First Posted

June 5, 2025

Study Start

June 16, 2025

Primary Completion

August 29, 2025

Study Completion

May 1, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations