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Not yet recruitingNCT06486831TSA-2023-12759Updated Jul 5, 2024

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

An interventional study of Squeeze the stress ball. in Plaster of Paris Injury to Skin, sponsored by Ataturk University. Not yet recruiting. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Plaster of Paris Injury to Skin

Keywords

  • Children
  • Plaster Intervention
  • Stress Ball
  • Anxiety
  • Fear
  • Trauma
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In context

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
116 participants (estimated)

Study arms

  • No intervention
    Control Group

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

  • Experimental
    Experimental Group

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

    Other: Squeeze the stress ball.

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.

06

What researchers measure

Primary outcomes

  1. Patient Identification Form

    In 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.

    Time frame: baseline

Secondary outcomes

  1. Children's Fear Scale (CFS)

    The 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.

    Time frame: baseline

Other outcomes

  1. Child Anxiety Scale-Dispositional (CAS-D)

    The 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.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 37414624 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06486831
Lead sponsor
Ataturk University
Responsible party
Zülbiye demir barbak (Lecturer, Ataturk University) — Principal investigator
First posted
Jul 5, 2024
Start date
Aug 20, 2024 (estimated)
Primary completion
Sep 1, 2024 (estimated)
Completion
Mar 20, 2025 (estimated)
Last update
Jul 5, 2024

Study contacts

Zülbiye DEMİR BARBAK, 1
Contact
zulbiye.demir@atauni.edu.tr
(442) 231 5821
Sultan Esra TEDİK, 2
Contact
esra.tedik@atauni.edu.tr
(442) 231 2757
Orhan DELİCE, 3
study chair · ERZURUM CITY HOSPİTAL

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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