NCT06229327

Brief Summary

This study was carried out as a randomized controlled experimental study in order to evaluate the effect of therapeutic game use on anxiety and fear levels before indwelling catheter intervention in children aged 6-12 years followed in the hematology oncology service. A simple randomization method was used to assign children to groups. Ethics committee and institutional permission was obtained for the research. Research data were obtained from a total of 80 children, 40 interventions and 40 controls, hospitalized in Istanbul Medical Faculty Pediatric Hematology Service between October 2022 and August 2023. Data; It was evaluated with the information form, child follow-up form, Child Anxiety Scale- State (ÇAS-D) and Child Fear Scale (CCS). For those assigned to the intervention group among the mother and child who signed the informed consent form; Before the indwelling catheter intervention, the children were shown the procedure on the amigrumi knitted baby developed by the researcher, the catheter application area was explained through the cardiovascular image and the catheter to be inserted was shown as an example. For those assigned to the control group; No intervention was applied other than the hospital\'s normal procedure. Data were evaluated using the SPPS 26 (IBM Corp. IBM 1989, 2019. SPSS Statistics for Windows, Version 26.0. Armonk, NY: IBM Corp.) package program. It was determined that the MCQ and ÇAS-D scores of the children in the intervention group were significantly lower than those in the control group (p˂0.01). It was determined that the mean CTA and respiratory rate of the children in the intervention group just before and 2 hours after the application were lower than the control group (p\<0.001). According to the results of the research, it was determined that the therapeutic game applied before indwelling catheter intervention in children between the ages of 6-12 was effective in reducing children's anxiety and fear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

October 21, 2023

Last Update Submit

January 29, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • children's anxiety scores

    Child Anxiety Scale-Conditioning (min:0-maks:10)

    30 minutes

  • children's fear scores

    Child Fear Scale (min:0-maks:4)

    30 minutes

Study Arms (1)

PEDİATRİC

EXPERIMENTAL

Children in the intervention group were played a therapeutic game explaining the procedure before indwelling catheter intervention. Children in the control group did not undergo any intervention other than the hospital's normal procedure before indwelling catheter intervention.

Behavioral: THERAPEUTICGAMES

Interventions

THERAPEUTICGAMES

PEDİATRİC

Eligibility Criteria

Age6 Years - 12 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being between the ages of 6-12 Being diagnosed with cancer Receiving chemotherapy treatment It will be the first time that a permanent catheter will be inserted.

You may not qualify if:

  • Being in the terminal period Hearing and/or visual impairment Having another health problem or condition that will prevent communication (Turkish inability to speak…etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinar Demirer

Istanbul, İ̇stanbul, 34094, Turkey (Türkiye)

Location

Related Publications (4)

  • Athanassiadou E, Tsiantis J, Christogiorgos S, Kolaitis G. An evaluation of the effectiveness of psychological preparation of children for minor surgery by puppet play and brief mother counseling. Psychother Psychosom. 2009;78(1):62-3. doi: 10.1159/000172623. Epub 2008 Nov 18. No abstract available.

  • Baranowski T, Blumberg F, Buday R, DeSmet A, Fiellin LE, Green CS, Kato PM, Lu AS, Maloney AE, Mellecker R, Morrill BA, Peng W, Shegog R, Simons M, Staiano AE, Thompson D, Young K. Games for Health for Children-Current Status and Needed Research. Games Health J. 2016 Feb;5(1):1-12. doi: 10.1089/g4h.2015.0026. Epub 2015 Aug 11.

  • Barton A, Ventura R, Vavrik B. Peripheral intravenous cannulation: protecting patients and nurses. Br J Nurs. 2017 Apr 27;26(8):S28-S33. doi: 10.12968/bjon.2017.26.8.S28.

  • Bawaeda O, Wanda D, Aprillia Z. Effectiveness of pop-it therapeutic play on children's anxiety during inhalation therapy in children's wards. Pediatr Med Chir. 2023 Mar 28;45(s1). doi: 10.4081/pmc.2023.315.

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 21, 2023

First Posted

January 29, 2024

Study Start

October 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations