Two Different Distraction Methods for Reducing Procedural Pain in Children

NCT06541964 | Completed

• 1 other identifier: 2024/12-05
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This research will be carried out in a randomized controlled experimental design in order to study the effect of parent-provide distraction and windmill toy blowing methods in reducing the pain caused by blood collection in children aged 6-12 who have applied to the children's blood collection unit. It will be taken by randomization so that there is no bias in the people who will be included in the study. Randomization table "https://www.calculatorsoup.com " it was created using. After randomization, the children in the parent-provide distraction group with parental participation will be asked riddles by the parent during the venous blood collection procedure. The children in the windmill toy blowing group will blow a windmill toy during the venous blood collection process. For the children in the control group, no distraction will be made during venous blood collection. As soon as the procedure is completed, the pain score during the procedure and the pain score will be evaluated one minute after the procedure. The evaluation will be made by the child, parent and nurse who draws blood.

Conditions

Procedural Pain

Keywords

Pain; Venous Blood Collection; Distraction

Outcome Measures

Primary Outcomes (1)

• Pain Evaluated by Children (Wong-Baker Faces Scale)

  Pain will be assessed by children with Wong-Baker Faces Scale. It is a valid and safe individual notification-based scale used to describe pain in children aged 3-18 (Wong-Baker Faces Foundation-http://wongbakerfaces.org/). It consists of 6 facial expressions ranging from smiling face to crying facial expression, which are scored Dec Decently from 0 to 10 to describe the severity of pain. As the score obtained from the scale increases, the severity of pain increases, and the severity decreases as the score decreases. "Face 0" means that there is no pain. He has a smiley face expression. "Face 2" has a little pain. "Face 4 " has a little more pain. There are more than "face 6" pain. The "face 8" pain is quite a lot. The pain of "face 10" is unbearable. The severity of the pain can be defined by enabling children to choose the shape of the face from the expression of their pain.

  During venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and one minute after venipuncture procedure (one minute after the injector was removed)

Secondary Outcomes (1)

• Pain Evaluated by Parents and Nurse (Visual Analog Scale)

  During venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and one minute after venipuncture procedure (one minute after the injector was removed)

Study Arms (3)

Parent-Provide Distraction Group

EXPERIMENTAL

Parent-Provide Distraction Group

Other: Parent-Provide Distraction

Windmill Toy Blowing Group

EXPERIMENTAL

Windmill Toy Blowing Group

Other: Windmill Toy Blowing

Control Group

OTHER

Control Group

Other: Control

Interventions

Parent-Provide Distraction OTHER

The children will be asked riddles by their parents for 5 seconds before and during the blood collection procedure.

Parent-Provide Distraction Group

Windmill Toy Blowing OTHER

The children will blow on the windmill toy for 5 seconds before and during the blood collection procedure.

Windmill Toy Blowing Group

Control OTHER

No intervention will make on the children.

Control Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The children whose between 6 and 12 years old,
• The children does not have a visual, hearing or mental problem,
• The children and the parent's knowledge of Turkish at the level of the mother tongue,
• The voluntary consent of the children and his/her parent to participate in the research.

You may not qualify if:

• The children whose younger than 6 years and older than 12 years,
• The children have a visual, hearing or mental problem,
• The children and the parent's inability to speak Turkish at the level of their native language,
• The children and the parent do not agree to participate in the research.

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; 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: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: August 30, 2024
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)