Effects of Therapeutic Play on Anxiety and Fear
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
1 other identifier
interventional
80
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
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
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedJanuary 31, 2024
January 1, 2024
10 months
October 21, 2023
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
EXPERIMENTALChildren 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.
Interventions
Eligibility Criteria
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
- Okan Universitylead
- Istanbul Universitycollaborator
Study Sites (1)
Pinar Demirer
Istanbul, İ̇stanbul, 34094, Turkey (Türkiye)
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.
PMID: 19018160RESULTBaranowski 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.
PMID: 26262772RESULTBarton 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.
PMID: 28453316RESULTBawaeda 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.
PMID: 36974915RESULT
MeSH Terms
Conditions
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