NCT07593001

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 18, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

April 25, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

Childhaemodialysisnursetime managementanxietyfear

Outcome Measures

Primary Outcomes (2)

  • the State Anxiety Inventory (Pre-training)

    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)

    After obtaining their consent during the first interview the Medical Procedure Fear Scale was administered as pre-tests.

    2 mounts

Secondary Outcomes (4)

  • the State Anxiety Inventory, (Post test)

    4 months

  • the Medical Procedure Fear Scale (Post test)

    4 months

  • the State Anxiety Inventory (Post test)

    5 mounts

  • the Medical Procedure Fear Scale (Post test)

    5 mounts

Study Arms (2)

Control

NO INTERVENTION

Rutin care

Training

EXPERIMENTAL
Behavioral: TRAINING GIVEN ON TIME MANAGEMENTOther: Control

Interventions

The intervention group received training after the pre-test, and the training's effectiveness was evaluated one week and one month later.

Training
ControlOTHER

There is no actual intervention, just rutin care

Training

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, 27310, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 18, 2026

Study Start

November 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 15, 2026

Last Updated

May 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations