Skip to main content
OpenTrials
Completed

NCT Number: NCT06772259

Comparison of the Effect of Two Different Interventions

The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years.

Hypotheses:

H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group.

H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group.

H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group.

H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group.

H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group.

H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group.

H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group.

H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group.

H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group.

H10: PIK application time is different in the palm stimulator group compared to the control group.

H11: PIK application time is different in the cartoon group compared to the co

Completed

Looking for future studies?

Notify Me

Key information

Conditions

To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous Catheterization Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University

Sakarya, Serdivan, 54050, Turkey (Türkiye)

About this study

  • To measure the pain and fear levels of children by placing a palm stimulator on their palms during PIK application
  • Measuring pain and fear levels by watching cartoons to children during PIK application

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation in the study,
  • Pediatric patients for whom written and verbal consent has been obtained from the parent,
  • Pediatric patients for whom verbal consent was obtained,

(3) Not under the influence of sedative/anticonvulsant/analgesic drugs, (4) Pediatric patients aged 5-12 years, (5) Pediatric patients who can communicate, understand, and carry out commands and are not dependent on technological devices.

Exclusion criteria

  • Not volunteering to participate in the study,
  • More than one PIK attempt,
  • Children with a chronic, acute, or life-threatening illness.

Treatment and study plan

Palm Stimulator

Device

The apparatus is 1.6 cm in diameter and 4 cm long. It has a cylindrical, non-slippery and easy-to-grasp structure for maximum contact with the palm

Cartoon

Other

The cartoon was projected on a blank wall in the intervention room with a projection device. The cartoon was played in preparation for the PIK procedure and children were allowed to watch it until the procedure was completed.

Primary outcomes

  1. Pain Measurement

    Time frame: 3 months

    Before, during, and after the PIK procedure in intervention and control groups. Wong-Baker FACES Pain Scale: The scale used to diagnose pain in children was developed by Donna Lee Wong and Connie Morain Baker. The Wong-Baker Scale has been reported to be safe to use in children aged 3-18 who can verbally describe the level of pain. The scale includes facial expressions and numbers. The scale has a total of six facial expressions, and pain is graded between 0-10 (Wong & Baker, 1988).

  2. Fear

    Time frame: 3 months

    Fear assessment before, during, and after the PIK procedure in intervention and control groups.

    Child Fear Scale: The Turkish psychometric properties of the scale adapted to pediatric patients as "Children's Fear Scale" by McMurty et al. (2011) were evaluated by Özalp Gerçeker et al. The CSA is a scale consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety) and evaluated between 0 and 4 (Özalp Gerçeker et al., 2018). It can be used by families and researchers to assess pain and anxiety before and during the procedure and is intended for children aged 5-10 years. In the Turkish reliability and validity study, the content validity index of the scale was found to be 0.89 (Özalp Gerçeker et al., 2018).

Secondary outcomes

  1. Saticfaction

    Time frame: 3 months

    Satisfaction assessment after the PIK procedure in intervention and control groups.

    Individuals were asked to give a score between 0-10 to determine their satisfaction. A score of "0" means "not at all satisfied", while a score of "10" means "very satisfied".

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Collaborators

  • Sakarya University Education and Research Hospital

Registry information

Official study title

Comparison of the Effect of Two Different Interventions on Pain and Fear in Peripheric Intravenous Catheterization in Children: A Randomized Controlled Study

Acronym: PIK

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.