- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07593001
TIME MANAGEMENT DURING HAEMODIALYSIS ON ANXIETY AND FEAR IN CHILDREN
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Gaziantep, Tyrkia (Türkiye), 27310
- Gaziantep University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Opplæring
|
The intervention group received training after the pre-test, and the training's effectiveness was evaluated one week and one month later.
There is no actual intervention, just rutin care
|
|
Ingen inngripen: Control
Rutin care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
the State Anxiety Inventory (Pre-training)
Tidsramme: 2 months
|
After obtaining their consent during the first interview, the State Anxiety Inventory, was administered as pre-tests.
|
2 months
|
|
the Medical Procedure Fear Scale (Pre-training)
Tidsramme: 2 mounts
|
After obtaining their consent during the first interview the Medical Procedure Fear Scale was administered as pre-tests.
|
2 mounts
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
the State Anxiety Inventory, (Post test)
Tidsramme: 4 months
|
When evaluating the results of the first measurement one week after training (Final test 1)) State Anxiety Inventory was assessed.
|
4 months
|
|
the Medical Procedure Fear Scale (Post test)
Tidsramme: 4 months
|
When evaluating the results of the first measurement one week after training (Final test 1)) the Medical Procedure Fear Scale was assessed.
|
4 months
|
|
the State Anxiety Inventory (Post test)
Tidsramme: 5 mounts
|
When evaluating the results of the second measurement one month after training (Final test 2)) the the State Anxiety Inventory was assessed.
|
5 mounts
|
|
the Medical Procedure Fear Scale (Post test)
Tidsramme: 5 mounts
|
When evaluating the results of the second measurement one month after training (Final test 2)) the Medical Procedure Fear Scale was assessed.
|
5 mounts
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Park, 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.
- Hosseini 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.
- Francis, 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.
- Akinkugbe, O., et al. (2024). Systematic review of CKD progression mechanisms in pediatric patients. Pediatric Nephrology, 39(4), 789-802.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GaziantepU
- SBF.YLP.26.05 (Annet stipend/finansieringsnummer: Gaziantep University Scientific Research Project)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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