- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296757
The Effect of Origami Activities on Comfort Level and Quality of Life
The Effect of Origami Activities on Comfort Level and Quality of Life in Patients Undergoing Hemodialysis Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing HD treatment must undergo dialysis 2-3 days a week, spend approximately 4 hours per day at the dialysis center, remain dependent on a center and caregiver throughout the treatment, experience mobility limitations, and experience disruptions in their social relationships. Patients can receive adequate treatment only if their physical, mental, and biochemical well-being are maintained.
Activities implemented by dialysis nurses during hemodialysis can be beneficial for HD patients. Art therapy, which is frequently of interest to individuals (painting, drawing, coloring, mandala painting, mural painting, clay modeling, collage, sculpture, ceramics, and model making), is a therapeutic activity that reduces anxiety, increases awareness, facilitates recovery from trauma, and improves social skills and self-esteem. Its benefits have been proven in various patient groups. Origami art is an art therapy known to provide behavioral, social, emotional, and psychomotor developmental benefits, and its therapeutic effects in HD patients have not been previously studied. In this context, this study aims to make a new scientific contribution to the literature of non-pharmacological nursing interventions by examining the effect of a 12-session origami activity on the comfort level and quality of life of patients undergoing hemodialysis treatment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Van, Turkey (Türkiye), 65030
- Van Özel Diyaliz Merkezi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older,
- Literate,
- Undergoing continuous hemodialysis treatment for at least six months,
- Receiving hemodialysis treatment three days a week,
- No visual impairment,
- No communication or perception problems and able to communicate in Turkish,
- No issues (wounds, arthritis, orthopedic impairments, etc.) in the upper extremities that would prevent paper folding,
- No arteriovenous fistula in the dominant arm used for folding,
- Has not received a psychiatric diagnosis and is not taking psychiatric medication,
- Voluntarily agrees to participate in the study,
- Has not previously participated in an activity such as origami.
Exclusion Criteria:
- Receiving dialysis treatment as an outpatient,
- Wishing to withdraw from the study at any stage
Study Plan
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: intervention
group doing origami activities
|
origami activity during a hemodialysis session
|
|
No Intervention: Control grup
The group that did not undergo any intervention during hemodialysis and received routine care from nurses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodialysis Comfort Scale-Version II
Time Frame: Change in comfort at the beginning of the intervention and at the end of the second week and at the end of the fourth week
|
Due to the insufficient number of items in the previously developed Hemodialysis Comfort Scale Koşar and colleagues developed the Hemodialysis Comfort Scale -Version II (HDCS-II) scale was developed by Koşar and colleagues, and the same authors conducted validity and reliability studies.
The scale consists of 26 items, and the responses to the items are prepared on a five-point Likert scale: never, very rarely, sometimes, very often, always.The scale has six subscales: physical relief, physical relaxation, psychospiritual relaxation, psychospiritual empowerment, environmental empowerment, and sociocultural relaxation.
While the scale includes both reverse-scored and forward-scored items, the number of reverse-scored items is predominant.
As the score on the scale increases, the patient's comfort also increases.
|
Change in comfort at the beginning of the intervention and at the end of the second week and at the end of the fourth week
|
|
Kidney Disease Quality of Life Short Form (KDQOLTM-SF 36.1.3)
Time Frame: Change in comfort at the beginning of the intervention and at the end of the fourth week
|
The Turkish reliability and validity of the scale developed by Hayy et al. (1994) was established by Yıldırım et al. (2007).
The scale consists of 36 items divided into 5 dimensions.
These subdimensions are symptom/problem list (12 items), impact of kidney disease (8 items), and burden of kidney disease (4 items).
The Likert method is used for scoring each item.
Scores range from 0 to 100 in each dimension.
|
Change in comfort at the beginning of the intervention and at the end of the fourth week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ayşe Gül Parlak, PhD, Kafkas University Health Science Faculty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KAU-SBF-HA-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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