NCT07296757

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

November 24, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

December 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

November 24, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

HemodialysisOrigamiComfortQuality of life

Outcome Measures

Primary Outcomes (2)

  • Hemodialysis Comfort Scale-Version II

    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)

    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

Study Arms (2)

intervention

EXPERIMENTAL

group doing origami activities

Other: origami

Control grup

NO INTERVENTION

The group that did not undergo any intervention during hemodialysis and received routine care from nurses

Interventions

origamiOTHER

origami activity during a hemodialysis session

intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Receiving dialysis treatment as an outpatient,
  • Wishing to withdraw from the study at any stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Özel Diyaliz Merkezi

Van, 65030, Turkey (Türkiye)

Location

Study Officials

  • Ayşe Gül Parlak, PhD

    Kafkas University Health Science Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Experimental: Intervention Group Patients in the intervention group will participate in origami activities three days a week, each lasting approximately 30 minutes. No intervention: Control Group Patients in the control group will receive an origami activity booklet and origami paper after the study. Each origami activity will be performed using simple shapes, following the order in the researcher-prepared booklet (with the advice of the origami art instructor).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC student

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 22, 2025

Study Start

December 8, 2025

Primary Completion

January 8, 2026

Study Completion

January 10, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations