Efficacy of Finger Puppet as a Distraction Method

NCT05073497 | Completed

• 1 other identifier: 2021/51-34
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted with the randomized controlled experimental method. The children who attended the pediatric emergency department will divide into two groups via randomization in the computer environment. After the randomization, children in the experimental group will play with finger puppets under the direction of the researcher during venipuncture. On the other hand, no application will perform on the children in the control group during the venipuncture. The parents will also be found next to their children in both groups during the procedure.

Conditions

Procedural Pain; Pain; Acute Pain

Keywords

Distraction; Finger puppet; pain management; procedural pain

Outcome Measures

Primary Outcomes (1)

• Change of pain from before venipuncture to during venipuncture

  Pain will assess by the healthcare provider who performs the venipuncture procedure with the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. This scale was developed to evaluate the pain of children aged 2 months to 7 years. The child's facial expression, leg movements, activity, crying, and comfortability behaviors are evaluated in relation to pain. These five behaviors are rated with 0, 1, or 2 points. The total score of the scale ranges from 0 to 10, and a high score indicates that the child has more pain. '0' points from the scale indicate no pain, '1-3' points indicate mild pain, '4-6' points indicate moderate pain, and '7-10' points indicate severe pain.

  Before venipuncture procedure and within 2 minutes after the venipuncture procedure

Secondary Outcomes (1)

• Change of emotional status from before venipuncture to during venipuncture

  Before venipuncture procedure and and within 2 minutes after the venipuncture procedure

Study Arms (2)

Experimental Group

EXPERIMENTAL

One minute before the procedure the children in the experimental group will start to play with finger puppets under the direction of the researcher. The researcher will continue to distract the child's attention during the procedure with finger puppets.

Other: Finger puppets

Control Group

NO INTERVENTION

No intervention will perform to reduce pain in the control group.

Interventions

Finger puppets OTHER

In the experimental group, for distraction the researcher will put finger puppets consisting of various animal figures on his finger, and will ask the child to imitate these sounds by making animal-specific sounds that he moves with his finger. The researcher will also draw the child's attention to finger puppets by using methods such as making animals talk to each other and singing before and during venipuncture.

Experimental Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being between the ages of 3 and 6,
• Having body temperature at normal level (36.5-37.2oC),
• Having no disease that can cause acute or chronic pain,
• Having no auditory, mental, and neurological disability that can affect their participation,
• Having no confusion.

You may not qualify if:

• Being younger than 3 years old and older than 6 years old,
• Having body temperature at a higher than normal level,
• Having a disease that can cause acute or chronic pain,
• Having auditory, mental, and neurological disability that can affect their participation,
• Having confusion.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Kartal, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Pain; Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Zeynep Erkut, PhD

  Maltepe University

  PRINCIPAL INVESTIGATOR

• Murat Ceylan, RN

  Kartal Dr. Lütfi Kirdar City Hospital

  PRINCIPAL INVESTIGATOR

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: September 18, 2021
• First Posted: October 11, 2021
• Study Start: October 15, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)