The Effect of Stress Ball in Reducing Anxiety and Fear in 6-12 Year Old Children

NCT ID: NCT06486831

Last Updated: 2024-07-05

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2025-03-20

Brief Summary

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The aim of this study was to determine the effect of stress ball application on procedure-related anxiety and fear during plaster cast procedure in children aged 6-12 years.

Detailed Description

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Children aged 6-12 years will be randomly divided into two groups: stress ball and control group. Interventions will be applied 1 time per day (2 sessions) for 2 days. Children in the experimental group will be given a stress ball during the plaster procedure and will be asked to squeeze it during the procedure. Children will be assessed before, during and after the intervention. Fear and anxiety related to the cast procedure will be assessed using the Children's Fear Scale, and the Children's Anxiety Scale - Statefulness Scale. In addition, children's heart rate, respiration, blood pressure and SPO2 will be measured.

Conditions

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Plaster of Paris Injury to Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control Group

Routine Plaster intervention will be applied to the control group. No action will be taken.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group

During the plaster intervention process, the experimental group will squeeze the stress ball.

Group Type EXPERIMENTAL

Squeeze the stress ball.

Intervention Type OTHER

The child and parents will be taken to the procedure room for the casting procedure. The plastering process in children takes an average of 10-15 minutes. In the experimental group, the stress ball selected by the child will be started 1-2 minutes before the casting process and will be watched for an average of 10 minutes. If the procedure is prolonged, the time for squeezing and playing with the stress ball will be extended.

Interventions

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Squeeze the stress ball.

The child and parents will be taken to the procedure room for the casting procedure. The plastering process in children takes an average of 10-15 minutes. In the experimental group, the stress ball selected by the child will be started 1-2 minutes before the casting process and will be watched for an average of 10 minutes. If the procedure is prolonged, the time for squeezing and playing with the stress ball will be extended.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age between 6 and 12 years (over 12 years old)
2. Absence of any physical and mental illness,
3. Not having taken analgesics in the last six hours
4. Hospitalization was for diagnostic or therapeutic purposes
5. The child and parents are comfortable speaking and understanding Turkish.

Exclusion Criteria

1. Children hospitalized for surgery will not be included in the study.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Zülbiye demir barbak

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Orhan DELİCE, 3

Role: STUDY_CHAIR

ERZURUM CITY HOSPİTAL

Central Contacts

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Zülbiye DEMİR BARBAK, 1

Role: CONTACT

(442) 231 5821

Sultan Esra TEDİK, 2

Role: CONTACT

(442) 231 2757

References

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Yurdakul Z, Esenay FI. Effects of two different ball types on pain and anxiety during venous blood draw in children: A randomized controlled study. J Pediatr Nurs. 2023 Sep-Oct;72:e201-e209. doi: 10.1016/j.pedn.2023.06.029. Epub 2023 Jul 5.

Reference Type RESULT
PMID: 37414624 (View on PubMed)

Other Identifiers

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TSA-2023-12759

Identifier Type: -

Identifier Source: org_study_id

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