Hemodialysis ComplicationNCT07296757
The Effect of Origami Activities on Comfort Level and Quality of Life
A study testing origami in people with Hemodialysis Complication, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- origami
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- Receiving dialysis treatment as an outpatient,
- Wishing to withdraw from the study at any stage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Origami Activities on Comfort Level and Quality of Life in Patients Undergoing Hemodialysis Treatment
This study was conducted to evaluate the effect of origami activity on the comfort levels and quality of life of patients undergoing HD treatment.
Read the 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.
- Conditions
- Hemodialysis Complication
- Being tested
- origami
- Keywords
- Hemodialysis, Origami, Comfort, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
origamiOther
origami activity during a hemodialysis session
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | group doing origami activities Receives: Other: origami |
| Control grup | No intervention | The group that did not undergo any intervention during hemodialysis and received routine care from nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change in comfort at the beginning of the intervention and at the end of the fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start8 Dec 2025
- Primary completion8 Jan 2026 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helin ATAY, Kafkas University
- Investigators
- Ayşe Gül Parlak, PhD, Study director, Kafkas University Health Science Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296757
- Sponsor's protocol ID
- KAU-SBF-HA-01
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Origami Activities on Comfort Level and Quality of Life in Patients Undergoing Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT07296757
- Acronym / sponsor ID
- KAU-SBF-HA-01
- Conditions
- Hemodialysis Complication
- Keywords
- Hemodialysis, Origami, Comfort, Quality of life
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 8 Jan 2026 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: origamigroup doing origami activities |
| Control grup | No intervention | –The group that did not undergo any intervention during hemodialysis and received routine care from nurses |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (2 listed)
- Receiving dialysis treatment as an outpatient,
- Wishing to withdraw from the study at any stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| origamiorigami activity during a hemodialysis session | Other | intervention |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayşe Gül Parlak, PhD study director
Kafkas University Health Science Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing origami in people with Hemodialysis Complication, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.