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The EFFECT of STRESS BALL DURING the PROCEDURE in CHILDREN

NCT05191901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-01-10

No results posted yet for this study

Summary

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.

Conditions

  • Having a Blood Draw

Interventions

OTHER

Stress Ball

Reducing pain and fear by squeezing a stress ball during the blood draw procedure.

Sponsors & Collaborators

  • Ayse Sonay Turkmen, Prof.Dr

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2022-04-30
Completion
2022-05-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05191901 on ClinicalTrials.gov