The Effect of Toy IV Catheter on Children's Pain, Fear and Emotional Indicators

NCT05747833 | Completed

• 1 other identifier: 10346826
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Research was conducted to determine the effect of preparation for the procedure with a toy IV catheter before IV catheterization in children aged 6-10 years, on children's pain, fear and emotional indicators. Methods: It is a randomized controlled intervention study. The study was completed with 80 children. There are two groups in the study. Before the IV catheterization, the children in the intervention group were treated with the toy IV catheter developed by the researchers on the knitted doll, and then the procedure was provided to them. Conversely, no intervention was applied to the control group other than the normal procedure of the hospital. Stratified block randomization method was used to assign children to groups. In the study; "Personal Data Collection Form", "Wong-Baker Faces Pain Scale (WBFPS)", "Child Fear Scale (CFS)" and "Child Emotional Manifestation Scale (CEMS)" were used to collect data.

Conditions

Intravenous Catheterization

Keywords

Toy; Therapeutic play; Preparation; Pain; Fear

Outcome Measures

Primary Outcomes (4)

• Personal data collection form

  The data collection form was prepared by the researchers in line with the literature (Başkaya, 2019; Gültekin, 2019; Szeszak et al., 2016; Tunç Tuna \& Açıkgoz 2015). In this form, 3 including the personal characteristics of the child, 9 questioning the illness and hospital experiences; There are 22 questions in total, 10 of which include parent and family characteristics.

  1.5 month

• Wong-Baker faces pain scale

  The scale is based on measuring the level of pain by scoring facial expressions of children aged 3-18. There is a numerical value for each facial expression in the scale. This numerical value gives us information about the child's pain level. The lowest numerical value is "0" and the highest numerical value is "5". A high score on the scale indicates a high level of pain. The application of the scale is quite simple. Faces and numbers are explained to the child and asked to choose the face that best expresses his or her pain. This scale was used by the researcher to evaluate the pain of children before the procedure. In addition, in order to determine the pain felt by the child during the procedure after the procedure, it was filled out independently by the child, parent and researcher.

  1.5 month

• Child Fear Scale

  The scale was developed by Mc Murtry et al. in 2011 to determine the anxiety level of children aged 5-10 years. There are various facial expressions in the scale and a numerical value is given for each facial expression. The lowest score obtained from the scale is "0" and the highest score is "4". The higher the score obtained from the scale, the higher the level of anxiety felt in the child. This scale was used by the researcher, parent and child to evaluate the anxiety of children before the procedure. After the procedure, it was filled again independently by the child, parent and researcher to determine the anxiety felt by the child during the procedure.

  1.5 month

• Child Emotional Manifestation Scale

  In the scale, emotional indicators are evaluated in terms of 5 parameters. These parameters are; facial expression, voice, activity, interaction and cooperation level. These five parameters are scored from 1 to 5, and the lowest "5" and the highest "25" points are obtained at the end of the evaluation of the scale. A low score from the scale indicates a positive emotional state, and an increase in a score indicates a negative emotional state. This scale was filled in independently by the parent and the researcher in order to evaluate the emotional indicators of the child during the procedure after the procedure.

  1.5 month

Study Arms (2)

Toy IV Catheter Before Peripheral Cannula application

EXPERIMENTAL

Intervention Group: Child Fear Scale will be applied to the children who will meet the inclusion criteria. The data collection form will be filled in by the researcher according to the information received from the patient file and parents. Children in the intervention group will be shown the procedure on the doll with the IV Catheter developed by the researchers, and then it will be applied to it.

Other: Children Preparation With a Toy IV Catheter Before Peripheral Cannula application

Standard of care

NO INTERVENTION

Control group will not be aplied other than the normal procedure of the hospital. In both groups, at the end of the procedure, the child's reactions will be observed during the procedure and the Wong-Baker Faces Pain Scale, the Child Anxiety Scale and the Child Emotional Indicators Scale will be filled independently by the researcher and the parent in line with the child's reactions.

Interventions

Children Preparation With a Toy IV Catheter Before Peripheral Cannula application OTHER

THE EFFECT OF PROCESSING PREPARATION WITH A TOY IV CATHETER BEFORE PERIPHERAL CANNULA APPLICATION ON CHILDREN'S PAIN, FEAR and EMOTIONAL INDICATORS

Toy IV Catheter Before Peripheral Cannula application

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Your child;
• Age between 6-10,
• To receive IV treatment upon the request of a physician,
• Being conscious and able to communicate verbally,
• Understanding and speaking Turkish,
• Having a mother and / or father with him,
• After the information, the child and his parents agree to participate in the study in writing and verbally,
• Pediatric Emergency Clinic has been accepted to the Green Area,
• Not using analgesic and / or sedative drugs in the last 8 hours.

You may not qualify if:

• Your child;
• Being younger than 6 and over 10 years old,
• Having pain,
• Having a high fever (body temperature of 38 ° C and above) Applying to the hospital with a complaint that requires urgent intervention such as convulsion or trauma,
• Having applied to the hospital by ambulance,
• Admitted to the Yellow or Red Area of the Pediatric Emergency Clinic after triage,
• Having had an IV catheter before,
• Having mental disability,
• Having a chronic and / or fatal disease, Having a diagnosis made by psychiatry,
• Communication problems with his family and / or himself (not speaking Turkish, agitation, etc.)

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Hazal

Eskişehir, Odunpazarı, 26240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Hazal USLU

  Eskişehir Osmangazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: February 28, 2023
• Study Start: July 14, 2020
• Primary Completion: May 15, 2022
• Study Completion: December 30, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)