Efficacy of Finger Puppet as a Distraction Method

March 30, 2022 updated by: Zeynep Erkut, Biruni University

The Effect of Finger Puppet on Children's Pain and Emotional Indicators Undergoing Venipuncture in Pediatric Emergency Department

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Many different non-pharmacological methods are used to cope with negative situations such as pain, fear and anxiety caused by invasive procedures in children. One of these non-pharmacological methods is the distraction. The American Pain Society recommends the use of distraction for pain control in children. With the distraction method, the child's pain is controlled and reduced by focusing the child's attention in another direction. Video games, virtual reality glasses, listening to music, watching cartoons, blowing balloons, reading books, playing with puppet/finger puppets are used as distraction methods. The aim of this study is to determine the effect of distraction method applied with finger puppet on the child's pain level and emotional indicators in children aged 3-6 years who applied to the pediatric emergency department and underwent venous blood collection. The sample size of the study has been determined by the power analysis (G*Power 3.1.9.2), in line with the results obtained from the studies which have been conducted using a similar research method. The sample size was found to be a total of 76 children including minimum of 38 children for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 80 children including 40 children in two groups. Information Form, Face, Legs, Activity, Cry, Consolability (FLACC) Scale, and Children's Emotional Manifestation Scale will use for data collection. Children and their parents who applied to the pediatric emergency unit will inform about the study. Information about children and their parents included in the study will ask by the researcher through face-to-face interviews and these data will record in 'Information Form' five minutes before the procedure. One minute before the procedure 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. 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. Children in the control group will be given routine practices and no distraction method will be applied. Before and during venipuncture children's pain will evaluate with the FLACC Scale and their emotional status will evaluate with the Children's Emotional Manifestation Scale by the healthcare provider who performs the venipuncture procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kartal
      • Istanbul, Kartal, Turkey
        • Kartal Dr. Lütfi Kırdar City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
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
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.
No Intervention: Control Group
No intervention will perform to reduce pain in the control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of pain from before venipuncture to during venipuncture
Time Frame: Before venipuncture procedure and within 2 minutes after the venipuncture procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of emotional status from before venipuncture to during venipuncture
Time Frame: Before venipuncture procedure and and within 2 minutes after the venipuncture procedure
Children's emotional status will assess by the healthcare provider who performs the venipuncture procedure with the Children's Emotional Manifestation Scale. This scale was developed to objectively evaluate children's emotional behaviors towards medical procedures. In the scale, emotional indicators are evaluated according to 5 parameters (facial expression, voice, activity, interaction, cooperation level). These five parameters are scored from 1 to 5, with the lowest '5' and the highest '25' points. A high score on the scale indicates that the child displays more negative emotional behavior during the procedure.
Before venipuncture procedure and and within 2 minutes after the venipuncture procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biruni University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zeynep Erkut, PhD, Maltepe University
  • Principal Investigator: Murat Ceylan, RN, Kartal Dr. Lütfi Kirdar City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/51-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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