Effects of Therapeutic Play on Anxiety and Fear

NCT ID: NCT06229327

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Pediatric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PEDİATRİC

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.

Group Type EXPERIMENTAL

THERAPEUTICGAMES

Intervention Type BEHAVIORAL

THERAPEUTICGAMES

Interventions

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THERAPEUTICGAMES

THERAPEUTICGAMES

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role collaborator

Okan University

OTHER

Sponsor Role lead

Responsible Party

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Gülzade Uysal

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pinar Demirer

Istanbul, İ̇stanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 19018160 (View on PubMed)

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.

Reference Type RESULT
PMID: 26262772 (View on PubMed)

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.

Reference Type RESULT
PMID: 28453316 (View on PubMed)

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.

Reference Type RESULT
PMID: 36974915 (View on PubMed)

Other Identifiers

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0000-0002-4213-175X

Identifier Type: -

Identifier Source: org_study_id

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