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NCT05191901: Stress ball
The EFFECT of STRESS BALL DURING the PROCEDURE in CHILDREN
NA trial testing Stress Ball in Having a Blood Draw in 116 participants. Completed in 20 May 2022.
30 April 2022
Quick facts
| Lead sponsor | Ayse Sonay Turkmen, Prof.Dr |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 116 |
| Start date | 14 March 2022 |
| Primary completion | 30 April 2022 |
| Estimated completion | 20 May 2022 |
| Sites | 2 locations across Turkey (Türkiye) |
Drugs / interventions tested
- Stress Ball
Conditions studied
- Having a Blood Draw — all drugs for Having a Blood Draw →
Sponsor
Ayse Sonay Turkmen, Prof.Dr
Who can join
Adults 7 to 12, any sex, with Having a Blood Draw. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This research was planned in a Randomized Controlled Experimental Research design with Pre-Test-Post-Test Control Group in order to determine the effect of the stress ball squeezing technique applied to children aged 7-12 during the vascular access procedure on the level of fear and pain in children. The data of the study were obtained from children aged 7-12 who came to the Karaman Training and Research Hospital Pediatrics Service between August 1 and October 31, 2020. The sample size was determined as 116 children in total, 58 children for each group. "Interview and Observation Form, Children's Fear Scale (CFS), Wong-Baker Faces, Stress Ball and Stopwatch" were used for data collection. In order to evaluate whether the research is ethically appropriate, an application was made to the Ethics Committee of Karamanoğlu Mehmetbey University School of Health Sciences and the necessary permission was obtained. Written permission was obtained from the Chief Physician of Karaman Training and Research Hospital in order to conduct the study in the Child Health and Diseases Service of Karaman Training and Research Hospital. Statistical analyzes of the study will be done in SPSS 21.0 package program. Number, percentage, mean and standard deviation values will be used from descriptive analyses. In the analysis of differences between groups, independent groups t test, paired t test, Anova, Mann Whitney U and Kruskal Wallis tests will be used. Tukey or Duncon tests will be used for further analysis. The change in the post-procedural pain level of children according to some variables will be evaluated with multiple and simple regression analyses. Significance level will be accepted as p\<0.05.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05191901
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Stress Ball
Trials testing the same drug.
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- NCT07265960 — Effects of Virtual Reality and Stress Ball on Fear, Pain, Anxiety, and Satisfaction in Ureterorenoscopy Patients · NA · recruiting
- NCT07108192 — The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety · NA · recruiting
- NCT07011355 — Effect of Stress Ball Use on Labor Pain and Birth Experience in Primiparous Women During Labor · NA · not yet recruiting
Other Ayse Sonay Turkmen, Prof.Dr trials
Trials by the same sponsor.
- NCT06857149 — Effect of Cırcadıan Feedıng on Growth Parameters of Preterm Newborn · NA · active not recruiting
- NCT06900127 — The Effects Of Safe Swadding On Newborns' Oxygen Saturation And Comfort Level · NA · completed
- NCT05180058 — Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol with Combination of Wrapping, Fetal Position · NA · completed
- NCT05099302 — The Effect of Cartoons Watched Before Surgery on Children's Fear Level · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05191901 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ayse Sonay Turkmen, Prof.Dr
- Last refreshed: 10 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05191901.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing