NCT06229327

Effects of Therapeutic Play on Anxiety and Fear

Completed NA Last updated 31 January 2024

What this trial tests

NA trial testing THERAPEUTICGAMES in Pediatric Cancer in 80 participants. Completed in 1 August 2023.

Timeline

1 October 2022

Primary endpoint
1 August 2023

1 August 2023

Quick facts

Lead sponsor	Okan University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	80
Start date	1 October 2022
Primary completion	1 August 2023
Estimated completion	1 August 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• THERAPEUTICGAMES

Conditions studied

• Pediatric Cancer — all drugs for Pediatric Cancer →

Sponsor

Okan University

Who can join

Adults 6 to 12, any sex, with Pediatric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.