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Efficacy of Finger Puppet as a Distraction Method

Primary Purpose

Procedural Pain, Pain, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Finger puppets
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Procedural Pain focused on measuring Distraction, Finger puppet, pain management, procedural pain

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kartal Dr. Lütfi Kırdar City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of emotional status from before venipuncture to during venipuncture
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.

Full Information

First Posted
September 18, 2021
Last Updated
March 30, 2022
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT05073497
Brief Title
Efficacy of Finger Puppet as a Distraction Method
Official Title
The Effect of Finger Puppet on Children's Pain and Emotional Indicators Undergoing Venipuncture in Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain, Pain, Acute Pain
Keywords
Distraction, Finger puppet, pain management, procedural pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention will perform to reduce pain in the control group.
Intervention Type
Other
Intervention Name(s)
Finger puppets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of pain from before venipuncture to during venipuncture
Description
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.
Time Frame
Before venipuncture procedure and within 2 minutes after the venipuncture procedure
Secondary Outcome Measure Information:
Title
Change of emotional status from before venipuncture to during venipuncture
Description
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.
Time Frame
Before venipuncture procedure and and within 2 minutes after the venipuncture procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Erkut, PhD
Organizational Affiliation
Maltepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murat Ceylan, RN
Organizational Affiliation
Kartal Dr. Lütfi Kirdar City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kartal Dr. Lütfi Kırdar City Hospital
City
Istanbul
State/Province
Kartal
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Finger Puppet as a Distraction Method

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