Plaster of Paris Injury to SkinTSA-2023-12759NCT06486831
The Effect of Stress Ball in Reducing Anxiety and Fear in 6-12 Year Old Children
A study testing Squeeze the stress ball. in people with Plaster of Paris Injury to Skin, run by Ataturk University.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Plaster of Paris Injury to Skin
- What is being tested?
- Squeeze the stress ball.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 6 and 12 years (over 12 years old)
- Absence of any physical and mental illness,
- Not having taken analgesics in the last six hours
- Hospitalization was for diagnostic or therapeutic purposes
- The child and parents are comfortable speaking and understanding Turkish.
Who cannot join
- Children hospitalized for surgery will not be included in the study.
- Those who are outside the inclusion criteria will not be included in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Stress Ball in Reducing Anxiety and Fear During Plastering Procedure in Extremity Fractures in Children Aged 6-12 Years
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.
- Conditions
- Plaster of Paris Injury to Skin
- Being tested
- Squeeze the stress ball.
- Keywords
- Children, Plaster Intervention, Stress Ball, Anxiety, Fear, Trauma
- Medical subject headings
- Anxiety Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squeeze the stress ball.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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Routine Plaster intervention will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | During the plaster intervention process, the experimental group will squeeze the stress ball. Receives: Other: Squeeze the stress ball. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start20 Aug 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaster of Paris Injury to SkinStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülbiye demir barbak, Ataturk University
- Investigators
- Orhan DELİCE, 3, Study chair, ERZURUM CITY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486831
- Sponsor's protocol ID
- TSA-2023-12759
- Acronym
- TSA-2023-12759
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball in Reducing Anxiety and Fear During Plastering Procedure in Extremity Fractures in Children Aged 6-12 Years
- ClinicalTrials.gov ID
- NCT06486831
- Acronym / sponsor ID
- TSA-2023-12759 / TSA-2023-12759
- Conditions
- Plaster of Paris Injury to Skin
- Keywords
- Children, Plaster Intervention, Stress Ball, Anxiety, Fear, Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine Plaster intervention will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: Squeeze the stress ball.During the plaster intervention process, the experimental group will squeeze the stress ball. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age between 6 and 12 years (over 12 years old)
- Absence of any physical and mental illness,
- Not having taken analgesics in the last six hours
- Hospitalization was for diagnostic or therapeutic purposes
- The child and parents are comfortable speaking and understanding Turkish.
Key exclusion criteria (2 listed)
- Children hospitalized for surgery will not be included in the study.
- Those who are outside the inclusion criteria will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental Group |
Primary outcome
Patient Identification Form
Time frame: baseline
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.
1 secondary outcome
Children's Fear Scale (CFS)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Results publication: PubMed 37414624Yurdakul 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orhan DELİCE, 3 study chair
ERZURUM CITY HOSPİTAL
Questions about this trial
What is this clinical trial studying?
A study testing Squeeze the stress ball. in people with Plaster of Paris Injury to Skin, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zülbiye DEMİR BARBAK, 1 ((442) 231 5821, zulbiye.demir@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Identification Form (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06486831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.