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Clinical Trials/NCT07296757
NCT07296757Enrolling By InvitationNot Applicable

The Effect of Origami Activities on Comfort Level and Quality of Life in Patients Undergoing Hemodialysis Treatment

Kafkas University2 sites in 1 country60 target enrollmentStarted: December 8, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
60
Locations
2
Primary Endpoint
Hemodialysis Comfort Scale-Version II

Study Overview

Brief Summary

This study was conducted to evaluate the effect of origami activity on the comfort levels and quality of life of patients undergoing HD 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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Helin ATAY

MsC student

Kafkas University

Study Sites (2)

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