HemodialysisNCT07156942
A Story-Based Game to Reduce Anxiety and Improve Compliance in Hemodialysis Patients: RCT
A study testing Story-Based Digital Game in people with Hemodialysis and Game-Based Learning, run by Afra ÇALIK at 1 site in Turkey (Türkiye).
Trial summary
This clinical study is testing whether a short, story-based digital game played during dialysis can help improve the health and well-being of patients receiving hemodialysis. The researchers believe that using a digital game with an engaging storyline may help reduce anxiety, increase knowledge about healthy eating… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis, Game-Based Learning, Adherence
- What is being tested?
- Story-Based Digital Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 80 years
- Receiving regular hemodialysis treatment for at least 6 months
- Oriented to time, place, and person
- Minimum primary school education
- Able and willing to provide informed consent
Who cannot join
- Refusal to participate in the study
- Inability to provide informed consent due to cognitive or communication difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategies to Strengthen Physical and Mental Health During Hemodialysis: Rhythm of Life
This clinical study is testing whether a short, story-based digital game played during dialysis can help improve the health and well-being of patients receiving hemodialysis. The researchers believe that using a digital game with an engaging storyline may help reduce anxiety, increase knowledge about healthy eating, and encourage patients to better follow their treatment plans.
The main hypothesis is that this interactive game will lead to lower anxiety levels, better understanding of dietary rules, and higher treatment adherence compared to standard care alone.
- Conditions
- Hemodialysis, Game-Based Learning, Adherence, Anxiety
- Being tested
- Story-Based Digital Game
- Keywords
- digital game, hemodialysis, adherence, anxiety, serious games
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Story-Based Digital GameBehavioural
Participants in this arm played a story-based digital game during their regular hemodialysis sessions. The game was administered once per week, with each session lasting approximately 10 to 15 minutes, over a 4-week period. The game was accessed via an online platform and designed to educate patients on dietary choices, fluid management, and dialysis self-care through interactive storytelling and decision-making tasks.
| Study group | Role | What they receive |
|---|---|---|
| Story-Based Digital Game | Experimental | Participants in this arm received a short, story-based digital game intervention during their hemodialysis sessions. The game was played once per week for 4 weeks, with each session lasting approximately 10-15 minutes. The game aimed to reduce anxiety, improve treatment adherence, and increase dietary knowledge by engaging patients in interactive scenarios related to dialysis care. Receives: Behavioral: Story-Based Digital Game |
| Standard Care | No intervention | Participants in this arm received standard hemodialysis care without any additional digital game or educational intervention. They followed the usual treatment routines provided by the dialysis unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Treatment Adherence Score
Assessed using the End-Stage Renal Disease Adherence Questionnaire to measure adherence to dialysis schedules and treatment routines.
Measured: Baseline, Week 2, Week 4
Secondary outcomes (2)
Change in Dietary Knowledge Score
Measured using the Hemodialysis Patients' Diet Knowledge Scale.
Measured: Baseline, Week 2, Week 4
Change in Anxiety Level
Assessed using the State Anxiety Inventory (STAI-S) to measure perceived anxiety during treatment.
Measured: Baseline, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afra ÇALIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Afra ÇALIK, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156942
- Sponsor's protocol ID
- 9566
- Other IDs
- Scientific Research Projects C
- Status last verified
- Aug 2025
- First submitted
- 17 May 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study results are currently under consideration for publication, and data sharing may interfere with the peer-review and publication process.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Strengthen Physical and Mental Health During Hemodialysis: Rhythm of Life
- ClinicalTrials.gov ID
- NCT07156942
- Acronym / sponsor ID
- 9566
- Conditions
- Hemodialysis, Game-Based Learning, Adherence, Anxiety
- Keywords
- digital game, hemodialysis, adherence, anxiety, serious games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Afra ÇALIKUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Sep 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 clinical study is testing whether a short, story-based digital game played during dialysis can help improve the health and well-being of patients receiving hemodialysis. The researchers believe that using a digital game with an engaging storyline may help reduce anxiety, increase knowledge about healthy eating, and encourage patients to better follow their treatment plans.
The main hypothesis is that this interactive game will lead to lower anxiety levels, better understanding of dietary rules, and higher treatment adherence compared to standard care alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Story-Based Digital Game | Experimental | Behavioral: Story-Based Digital GameParticipants in this arm received a short, story-based digital game intervention during their hemodialysis sessions. The game was played once per week for 4 weeks, with each session lasting approximately 10-15 minutes. The game aimed to reduce anxiety, improve treatment adherence, and increase dietary knowledge by engaging patients in interactive scenarios related to dialysis care. |
| Standard Care | No intervention | –Participants in this arm received standard hemodialysis care without any additional digital game or educational intervention. They followed the usual treatment routines provided by the dialysis unit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged between 18 and 80 years
- Receiving regular hemodialysis treatment for at least 6 months
- Oriented to time, place, and person
- Minimum primary school education
- Able and willing to provide informed consent
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- Inability to provide informed consent due to cognitive or communication difficulties
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 |
|---|---|---|
| Story-Based Digital GameParticipants in this arm played a story-based digital game during their regular hemodialysis sessions. The game was administered once per week, with each session lasting approximately 10 to 15 minutes, over a 4-week period. The game was accessed via an online platform and designed to educate patients on dietary choices, fluid management, and dialysis self-care through interactive storytelling and decision-making tasks. | Behavioural | Story-Based Digital Game |
Primary outcome
Change in Treatment Adherence Score
Time frame: Baseline, Week 2, Week 4
Assessed using the End-Stage Renal Disease Adherence Questionnaire to measure adherence to dialysis schedules and treatment routines.
2 secondary outcomes
Change in Dietary Knowledge Score
Time frame: Baseline, Week 2, Week 4
Change in Anxiety Level
Time frame: Baseline, Week 2, Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- The full version of the game can be accessed online via the linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study results are currently under consideration for publication, and data sharing may interfere with the peer-review and publication process.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Story-Based Digital Game in people with Hemodialysis and Game-Based Learning, run by Afra ÇALIK 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 5 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: finished, as of the sponsor's last update on 5 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Treatment Adherence Score (time frame: Baseline, Week 2, Week 4). 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 5 Sep 2025.