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Clinical Trials/NCT06229327
NCT06229327
Completed
N/A

The Effect of Therapeutic Play on Anxiety and Fear Levels Before Indwelling Catheter Intervention in Children Aged 6-12 Years Followed up in Hematology Oncology Service: a Randomized Controlled Trial

Okan University1 site in 1 country80 target enrollmentOctober 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Cancer
Sponsor
Okan University
Enrollment
80
Locations
1
Primary Endpoint
children's fear scores
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Okan University
Responsible Party
Principal Investigator
Principal Investigator

Gülzade Uysal

Associate professor

Okan University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

children's fear scores

Time Frame: 30 minutes

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

children's anxiety scores

Time Frame: 30 minutes

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

Study Sites (1)

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