Haemodialysis PatientsNCT07593001
TIME MANAGEMENT DURING HAEMODIALYSIS ON ANXIETY AND FEAR IN CHILDREN
A study testing TRAINING GIVEN ON TIME MANAGEMENT in people with Haemodialysis Patients and Care, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study aims to determine the effect of time management training on anxiety and fear levels in children undergoing haemodialysis treatment. It is anticipated that the structured time management training provided to children will contribute to the treatment process. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemodialysis Patients, Care, Children
- What is being tested?
- TRAINING GIVEN ON TIME MANAGEMENT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 15 Apr 2026
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 9-12,
- Children who can speak and understand Turkish,
- Children without communication problems,
- Children without learning disabilities,
- Children approved by their families,
- Children without physical disabilities.
Who cannot join
- Children who refuse to participate in the study,
- Children who do not speak Turkish,
- Children with communication problems,
- Children with learning disabilities,
- Children with intellectual disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF THE TRAINING GIVEN ON TIME MANAGEMENT DURING HAEMODIALYSIS ON ANXIETY AND FEAR IN CHILDREN
Aim: This study aims to determine the effect of time management training on anxiety and fear levels in children undergoing haemodialysis treatment. It is anticipated that the structured time management training provided to children will contribute to the treatment process.
Method: This study has a randomised controlled experimental design. The study was conducted at the Gaziantep University Sahinbey Research and Application Hospital Children's Nephrology Diseases Hemodialysis Unit between 1 November 2025 and 1 April 2026. The study sample consisted of children aged 9-12 undergoing hemodialysis treatment at this unit. The sample group was randomly divided into intervention and control groups. The intervention group received training after the pre-test, and the training's effectiveness was evaluated one week and one month later. The control group received routine care. Data were collected using a questionnaire, the State-Trait Anxiety Inventory for Children, and the Medical Procedure Fear Scale.
- Conditions
- Haemodialysis Patients, Care, Children
- Being tested
- TRAINING GIVEN ON TIME MANAGEMENT, Control
- Keywords
- Child, haemodialysis, nurse, time management, anxiety, fear
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAINING GIVEN ON TIME MANAGEMENTBehavioural
The intervention group received training after the pre-test, and the training's effectiveness was evaluated one week and one month later.
ControlOther
There is no actual intervention, just rutin care
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Rutin care |
| Training | Experimental | Not described Receives: Behavioral: TRAINING GIVEN ON TIME MANAGEMENT; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
the State Anxiety Inventory (Pre-training)
After obtaining their consent during the first interview, the State Anxiety Inventory, was administered as pre-tests.
Measured: 2 months
the Medical Procedure Fear Scale (Pre-training)
After obtaining their consent during the first interview the Medical Procedure Fear Scale was administered as pre-tests.
Measured: 2 mounts
Secondary outcomes (4)
the State Anxiety Inventory, (Post test)
When evaluating the results of the first measurement one week after training (Final test 1)) State Anxiety Inventory was assessed.
Measured: 4 months
the Medical Procedure Fear Scale (Post test)
When evaluating the results of the first measurement one week after training (Final test 1)) the Medical Procedure Fear Scale was assessed.
Measured: 4 months
the State Anxiety Inventory (Post test)
When evaluating the results of the second measurement one month after training (Final test 2)) the the State Anxiety Inventory was assessed.
Measured: 5 mounts
the Medical Procedure Fear Scale (Post test)
When evaluating the results of the second measurement one month after training (Final test 2)) the Medical Procedure Fear Scale was assessed.
Measured: 5 mounts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Nov 2025
- Primary completion1 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Haemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP ÖZDEMİR, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593001
- Sponsor's protocol ID
- GaziantepU
- Other IDs
- SBF.YLP.26.05
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raina M, Shah R, Hu J, Pember B, Cahill T, Bunchman T, Yap HK, McCulloch M. The global health burden of pediatric chronic kidney disease: An analysis of the Global Burden of Disease database from 1990 to 2021. PLoS One. 2025 May 27;20(5):e0323257. doi: 10.1371/journal.pone.0323257. eCollection 2025.
PubMed 40424235Park, M. J. (2023). Anemia in children with chronic kidney disease: Current insights. Children's Kidney Journal, 7(3), 201-210.
Panzarino V, Lesser J, Cassani FA. Pediatric Chronic Kidney Disease. Adv Pediatr. 2022 Aug;69(1):123-132. doi: 10.1016/j.yapd.2022.03.008.
PubMed 35985704Hosseini T, Hooshmandja M, Noaparast M, Mojtahedzadeh R, Mohammadi A. Virtual reality exposure therapy to decrease anxiety before surgical invasive procedures in hemodialysis patients: an interventional study. BMC Nephrol. 2024 Jan 24;25(1):30. doi: 10.1186/s12882-024-03461-w.
PubMed 38267868Francis, A., et al. (2024). Key pediatric considerations from the KDIGO 2024 CKD guidelines. JAMA Pediatrics, 178(5), 433-440.
Cirillo L, De Chiara L, Innocenti S, Errichiello C, Romagnani P, Becherucci F. Chronic kidney disease in children: an update. Clin Kidney J. 2023 Apr 24;16(10):1600-1611. doi: 10.1093/ckj/sfad097. eCollection 2023 Oct.
PubMed 37779846Akinkugbe, O., et al. (2024). Systematic review of CKD progression mechanisms in pediatric patients. Pediatric Nephrology, 39(4), 789-802.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF THE TRAINING GIVEN ON TIME MANAGEMENT DURING HAEMODIALYSIS ON ANXIETY AND FEAR IN CHILDREN
- ClinicalTrials.gov ID
- NCT07593001
- Acronym / sponsor ID
- GaziantepU
- Conditions
- Haemodialysis Patients, Care, Children
- Keywords
- Child, haemodialysis, nurse, time management, anxiety, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 18 May 2026 (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.
Aim: This study aims to determine the effect of time management training on anxiety and fear levels in children undergoing haemodialysis treatment. It is anticipated that the structured time management training provided to children will contribute to the treatment process.
Method: This study has a randomised controlled experimental design. The study was conducted at the Gaziantep University Sahinbey Research and Application Hospital Children's Nephrology Diseases Hemodialysis Unit between 1 November 2025 and 1 April 2026. The study sample consisted of children aged 9-12 undergoing hemodialysis treatment at this unit. The sample group was randomly divided into intervention and control groups. The intervention group received training after the pre-test, and the training's effectiveness was evaluated one week and one month later. The control group received routine care. Data were collected using a questionnaire, the State-Trait Anxiety Inventory for Children, and the Medical Procedure Fear Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Rutin care |
| Training | Experimental | Behavioral: TRAINING GIVEN ON TIME MANAGEMENT, Other: Control |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 9-12,
- Children who can speak and understand Turkish,
- Children without communication problems,
- Children without learning disabilities,
- Children approved by their families,
Key exclusion criteria (5 listed)
- Children who refuse to participate in the study,
- Children who do not speak Turkish,
- Children with communication problems,
- Children with learning disabilities,
- Children with intellectual disabilities.
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 |
|---|---|---|
| TRAINING GIVEN ON TIME MANAGEMENTThe intervention group received training after the pre-test, and the training's effectiveness was evaluated one week and one month later. | Behavioural | Training |
| ControlThere is no actual intervention, just rutin care | Other | Training |
Primary outcome
the State Anxiety Inventory (Pre-training)
Time frame: 2 months
After obtaining their consent during the first interview, the State Anxiety Inventory, was administered as pre-tests.
the Medical Procedure Fear Scale (Pre-training)
Time frame: 2 mounts
After obtaining their consent during the first interview the Medical Procedure Fear Scale was administered as pre-tests.
4 secondary outcomes
the State Anxiety Inventory, (Post test)
Time frame: 4 months
the Medical Procedure Fear Scale (Post test)
Time frame: 4 months
the State Anxiety Inventory (Post test)
Time frame: 5 mounts
the Medical Procedure Fear Scale (Post test)
Time frame: 5 mounts
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 18 May 2026.
- Results publication: PubMed 40424235Raina M, Shah R, Hu J, Pember B, Cahill T, Bunchman T, Yap HK, McCulloch M. The global health burden of pediatric chronic kidney disease: An analysis of the Global Burden of Disease database from 1990 to 2021. PLoS One. 2025 May 27;20(5):e0323257. doi: 10.1371/journal.pone.0323257. eCollection 2025.
- Results publicationPark, M. J. (2023). Anemia in children with chronic kidney disease: Current insights. Children's Kidney Journal, 7(3), 201-210.
- Results publication: PubMed 35985704Panzarino V, Lesser J, Cassani FA. Pediatric Chronic Kidney Disease. Adv Pediatr. 2022 Aug;69(1):123-132. doi: 10.1016/j.yapd.2022.03.008.
- Results publication: PubMed 38267868Hosseini T, Hooshmandja M, Noaparast M, Mojtahedzadeh R, Mohammadi A. Virtual reality exposure therapy to decrease anxiety before surgical invasive procedures in hemodialysis patients: an interventional study. BMC Nephrol. 2024 Jan 24;25(1):30. doi: 10.1186/s12882-024-03461-w.
- Results publicationFrancis, A., et al. (2024). Key pediatric considerations from the KDIGO 2024 CKD guidelines. JAMA Pediatrics, 178(5), 433-440.
- Results publication: PubMed 37779846Cirillo L, De Chiara L, Innocenti S, Errichiello C, Romagnani P, Becherucci F. Chronic kidney disease in children: an update. Clin Kidney J. 2023 Apr 24;16(10):1600-1611. doi: 10.1093/ckj/sfad097. eCollection 2023 Oct.
- Results publicationAkinkugbe, O., et al. (2024). Systematic review of CKD progression mechanisms in pediatric patients. Pediatric Nephrology, 39(4), 789-802.
- Individual participant dataSharing planned: No
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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 TRAINING GIVEN ON TIME MANAGEMENT in people with Haemodialysis Patients and Care, run by Istanbul University - Cerrahpasa 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 6 inclusion and 5 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 18 May 2026. 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?
the State Anxiety Inventory (Pre-training) (time frame: 2 months). 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?
On the ClinicalTrials.gov record for NCT07593001, which also lists 7 linked publications.
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 18 May 2026.