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Completed

NCT Number: NCT06229327

Effects of Therapeutic Play on Anxiety and Fear

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pinar Demirer

Istanbul, İ̇stanbul, 34094, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

THERAPEUTICGAMES

Behavioral

THERAPEUTICGAMES

Primary outcomes

  1. children's anxiety scores

    Time frame: 30 minutes

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

  2. children's fear scores

    Time frame: 30 minutes

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

Sponsors and collaborators

Lead sponsor

Okan University

Other

Collaborators

  • Istanbul University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2024
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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