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

The Effect of Stress Ball in Reducing Anxiety and Fear During Plastering Procedure in Extremity Fractures in Children Aged 6-12 Years

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06486831
Acronym
TSA-2023-12759
Enrollment
116
Registered
2024-07-05
Start date
2024-08-20
Completion date
2025-03-20
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaster of Paris Injury to Skin

Keywords

Children, Plaster Intervention, Stress Ball, Anxiety, Fear, Trauma

Brief summary

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

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.

Interventions

OTHERSqueeze 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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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. 2. Those who are outside the inclusion criteria will not be included in the study.

Design outcomes

Primary

MeasureTime frameDescription
Patient Identification FormbaselineIn this form, there are questions about the child's age, gender, weight, age of the mother and father, presence of long-term illness, previous hospitalization status and reason, previous surgery status, presence of medication on continuous use, analgesic intake in the last 6 hours.

Secondary

MeasureTime frameDescription
Children's Fear Scale (CFS)baselineThe CFS, which was first used in 2003, is a scale with proven validity and reliability developed to assess the child's fear/anxiety and its level. The scale includes five different facial expressions, with no fear/anxiety at one end and very intense fear/anxiety at the other end, and is evaluated on a 0-4 point scale. 0: no fear/anxiety, 4: extreme fear and anxiety.

Other

MeasureTime frameDescription
Child Anxiety Scale-Dispositional (CAS-D)BaselineThe CAS-D is shaped like a thermometer with a bulb at the bottom and horizontal lines with intervals going upwards. It is intended for children aged 4-10 years. The scale instructs children to Imagine that all your anxious or angry feelings are at the bulb or bottom of the thermometer. Following the data collection, two members of the research team review and score the child's CAS-D scores. The score can range from 0 to 10.

Contacts

Primary ContactZülbiye DEMİR BARBAK, 1
zulbiye.demir@atauni.edu.tr(442) 231 5821
Backup ContactSultan Esra TEDİK, 2
esra.tedik@atauni.edu.tr(442) 231 2757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026