The EFFECT of STRESS BALL DURING the PROCEDURE in CHILDREN

NCT05191901 | Completed

• 1 other identifier: Stress Ball
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Pain; Turning Attention; Establishing intravascular access; Fear

Outcome Measures

Primary Outcomes (2)

• Pain scores

  5 minutes

• Fear scores

  5 minutes

Study Arms (2)

stress ball group

EXPERIMENTAL

Other: Stress Ball

control group

NO INTERVENTION

Interventions

Stress Ball OTHER

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

stress ball group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child is between the ages of 7-12
• Absence of pain (due to disease, drug side effects, distension)
• Absence of any physical or mental illness
• Being able to communicate and being open to communication
• No history of ischemic epilepsy, migraine or vestibular disorder
• No long-term illness.
• Absence of a regularly used medication
• Not taking analgesics in the last six hours
• Hospitalization for diagnosis or treatment
• Vascular access is performed by the same nurse,
• Single way vascular access
• The child and parent speak and understand Turkish comfortably,
• The child and his parents do not accept to participate in the study, and they do not have a speech or vision disorder.

Sponsors & Collaborators

• Ayse Sonay Turkmen, Prof.Dr: lead

Study Sites (2)

KaramanogluMehmetbeyU

Karaman, Turkey, 70100, Turkey (Türkiye)

Location

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 14, 2022
• Study Start: March 14, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 20, 2022
• Last Updated: January 10, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)