Intravenous Catheter Application

NCT07127081 | Not Yet Recruiting

• 1 other identifier: Toros University
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion. Hypotheses of the Study Hypothesis 1: Children who watch cartoons during intravenous catheter insertion have lower pain and fear scores than the control group. Hypothesis 2: The pain and fear of children who squeeze a stress ball during intravenous catheter insertion are lower than the control group Hypothesis 3: There is a difference between the pain and fear scores of children who watch cartoons and squeeze a stress ball.

Conditions

6-12 Years Old

Keywords

Children; intravenous catheter; stress ball; cartoons; nursing

Outcome Measures

Primary Outcomes (2)

• Wong-Baker Pain Scale

  It is the most frequently used pain assessment method. Facial expressions are considered as reliable and unbiased markers. It was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. It is suitable to be applied at the age of three years and above. The pain level of the faces on the scale is explained to the child: "0= no pain.......10= unbearably severe pain". According to the scoring; 0-4 indicates mild pain, 5-6 indicates moderate pain, 7-8 indicates severe pain, 9-10 indicates unbearably severe pain. The administration time of the measurement tool is approximately 2 minutes \[9,10,11\].

  22 weeks

• Children's Fear Scale

  It evaluates pain-related fear in children. The Child Fear Scale (CFS), developed by McMurty et al. (2011) and validated in Turkish by Özalp-Gerçeker et al. (2018), consists of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety). In the validity-reliability study, the CQI value for the scale was found to be 0.89. The test-retest reliability (0.99) was found to be quite high. The scale cut-off point is 2 and scores of 2 and above are characterised as high level of fear. The Child Fear Scale is a valid and reliable measurement tool. The administration time of the measurement tool is approximately 2 minutes \[12,13\].

  22 weeks

Study Arms (3)

Stress ball

EXPERIMENTAL

Stress ball will be applied

Behavioral: Stress ball

Cartoons

EXPERIMENTAL

Cartoons will be applied

Behavioral: Cartoons

Control

NO INTERVENTION

No intervention will be made to this group.

Interventions

Stress ball BEHAVIORAL

The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion.

Stress ball

Cartoons BEHAVIORAL

The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion.

Cartoons

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Those who were admitted to Toros State Hospital, Child service on 01 September 2025- 01.02.2026,
• Children aged 6 to 12 years,
• Children scheduled for intravenous catheterisation,
• Children without mental and developmental retardation,
• Children who can speak and understand Turkish,
• Children and parents who signed an informed consent form.

You may not qualify if:

• Children who cannot speak or communicate in Turkish,
• Children whose first attempt to insert an intravenous catheter failed,
• Children and parents who did not sign the informed consent form.

Sponsors & Collaborators

• Toros University: lead

Central Study Contacts

Behire Sançar, Dr. PhD

CONTACT

05052520273; behiresancar@gmail.com

Zühal Artuvan, Dr. PhD

CONTACT

05053834759; zuhalartuvan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Model Details: There will be tree groups (2 intervention, 1 control

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 17, 2025
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share