Intravenous Catheter Application

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorToros University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Stress ballExperimental treatment 1 intervention
Group B: CartoonsExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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 \[9,10,11\].

Time frame
22 weeks
2

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 \[12,13\].

Time frame
22 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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