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The Effects of Finger Puppet, Abeslang Puzzle, and Pinwheel on Pain and Anxiety During Blood Sampling Procedures

Primary Purpose

Pain, Acute, Anxiety, Child, Only

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PFA
Sponsored by
Bartın Unıversity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain, Acute

Eligibility Criteria

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

Inclusion Criteria: Being between 4-6 years old Referring to the pediatric emergency department Having consent and approval from the parent and child to participate in the study Having a necessity for blood testing in the child. Exclusion Criteria: Having visual, hearing, or speech impairment Having chronic or genetic diseases Having intellectual disability Having a history of sedative, narcotic, or analgesic drug use within the past 24 hours Having inflammatory diseases Being classified under the red triage category Unwilling to participate in the study.

Sites / Locations

  • Fatma DinçRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Pinwheel Group

Finger Puppet Group

Abeslang Puzzle Group

Control

Arm Description

In the pinwheel group, a windmill made of colored cardboard is introduced to the children, and then they are asked to blow on the pinwheel during the blood sampling procedure.The blood sampling is terminated at the same time by blowing the pinwheel.

In the finger puppet group, a finger puppet made of felt is introduced to the children, and they are told a story (Brave Little Rabbit) by the same researcher using the finger puppet.The blood sampling is terminated at the same time by reading story with finger puppet.

In the abeslang puzzle group, a puzzle made of colorful abeslang pieces with animal images (sheep, duck) is introduced to the children, and then they are asked to complete the puzzle using their non-dominant hand during the blood sampling procedure.The blood sampling is terminated at the same time by completing abeslang puzzle.

Children in the control group are monitored during the blood sampling procedure if their informed consent is obtained by the researcher. They have the routine blood draw procedure, and do not receive any distraction techniques and other pharmacological interventions.

Outcomes

Primary Outcome Measures

The level of pain during blood sampling is evaluated using the Wong-Baker FACES Pain Rating Scale
This scale is used to assess the severity of pain in children aged 3 years and above. This numerical rating scale ranges from 0 to 10, indicating emotions ranging from no pain/very happy (0) to crying/hurts worst (10). Higher scores indicate a lower pain tolerance. In this study, this scale is evaluated using personal reports and records from children, their parents, the researcher, and the nurse after the blood sampling procedure.

Secondary Outcome Measures

The level of anxiety is evaluated using the Children Anxiety Meter-State
The Children's Anxiety Meter (CAM-S) assesses children's anxiety in clinical settings and is used prior to medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom and contains horizontal lines at intervals going upwards. Scale scores range from 0 to 10, where higher values represent higher anxiety. Personal reports and records from children, their parents, the researcher, and the nurse, who are asked to mark the scale with a pen, are used to assess the anxiety levels of children regarding blood sampling before and after the procedure.

Full Information

First Posted
June 6, 2023
Last Updated
June 20, 2023
Sponsor
Bartın Unıversity
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1. Study Identification

Unique Protocol Identification Number
NCT05904483
Brief Title
The Effects of Finger Puppet, Abeslang Puzzle, and Pinwheel on Pain and Anxiety During Blood Sampling Procedures
Official Title
The Effects of Finger Puppet, Abeslang Puzzle, and Pinwheel on Pain and Anxiety in Children Aged 4-6 Years During Blood Sampling Procedures in Emergency Rooms: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
August 20, 2024 (Anticipated)
Study Completion Date
August 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bartın Unıversity

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
Blood sampling is an invasive, diagnostic, and therapeutic procedure for children. The inability of preschool children to differentiate between reality and imagination and their belief in the power of their thoughts make it difficult for them to accept an invasive procedure. Distraction techniques are used to help children cope with pain and anxiety. The aim of this study is to compare the effects of finger puppet, abeslang puzzle, and pinwheel on pain and anxiety during blood sampling in preschool children presenting to the pediatric emergency department. This randomized controlled study used parallel trial design.
Detailed Description
The research hypotheses are as follows: H1: Children in the finger puppet group experience lower procedure-related pain than those in the control group. H2: Children in the pinwheel group experience lower procedure-related pain than those in the control group. H3: Children in the abeslang puzzle group experience lower procedure-related pain than those in the control group. H4: Children in the finger puppet group have lower anxiety than those in the control group. H5: Children in the pinwheel group have lower anxiety than those in the control group. H6: Children in the abeslang group have lower anxiety than those in the control group. Methods: This randomized controlled study plans to include children aged 4-6 years presenting to the pediatric emergency department of Bartın Maternity and Child Health Hospital. The study utilizes a parallel trial design, defining three different intervention groups (pinwheel, abeslang puzzle, finger puppet) and a control group (standard care). An independent statistician (www.randomize.org) allocates participants to groups using a randomization method according to sampling criteria. Since there is no similar study about the effects of finger puppet, abeslang puzzle, and pinwheel on pain and anxiety during blood sampling in children, the study aims for a medium effect size (0.25) to determine the sample size (Cohen, 2013). Considering a medium effect size (f: 0.25), a power of 80% (1 - β error), and a confidence level of 95% (α error), the sample of the study should include 180 children (G*Power 3.1.9.7) (Faul, 2014). Considering potential data losses, the sample size is increased by 10%, resulting in 200 children with 50 children in each group. Children and their parents are informed about the study, and after obtaining their consent, they are assigned to their respective groups. A standard approach is applied to all pediatric patients, which includes providing information about the procedure, introducing the nurse, selecting the intervention area together, having the parent present during the procedure, and engaging in conversation with the child. No additional intervention is applied to children in the control group, and after obtaining their parental consent, they are observed during the procedure. In the finger puppet group, a finger puppet made of felt is introduced to the selected child, and a story (Brave Little Rabbit) is told using the finger puppet. The finger puppet is wiped with a disinfectant before and after the intervention. In the abeslang puzzle group, a puzzle made of colorful abeslang pieces with animal images (sheep, duck) is introduced to the selected child, and then the child is asked to complete the puzzle using their non-dominant hand, while the blood sampling procedure is being performed. Each child in the abeslang puzzle group receives the same number of puzzle pieces with the same design. In the pinwheel group, a windmill made of colored cardboard is introduced to the selected child, and then the child is asked to blow on the pinwheel during the blood sampling procedure. The pinwheel is wiped with a disinfectant before and after the intervention. All blood sampling procedures are performed by the same nurse, and the same researcher is present during all interventions. Research data is collected by the following data collection forms: Personal Information Form: The form consists of 4 questions in total, including age, gender, presence of previous injection experience, and number of previous injection experience. Wong-Baker FACES (WB-FACES) Pain Rating Scale: This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. The Children's Anxiety Meter (CAM). This scale assesses children's anxiety in clinical settings and uses before medical procedures. Children are asked to mark how they feel "right now" to measure state anxiety (CAM-S). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Anxiety, Child, Only

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pinwheel Group
Arm Type
Experimental
Arm Description
In the pinwheel group, a windmill made of colored cardboard is introduced to the children, and then they are asked to blow on the pinwheel during the blood sampling procedure.The blood sampling is terminated at the same time by blowing the pinwheel.
Arm Title
Finger Puppet Group
Arm Type
Experimental
Arm Description
In the finger puppet group, a finger puppet made of felt is introduced to the children, and they are told a story (Brave Little Rabbit) by the same researcher using the finger puppet.The blood sampling is terminated at the same time by reading story with finger puppet.
Arm Title
Abeslang Puzzle Group
Arm Type
Experimental
Arm Description
In the abeslang puzzle group, a puzzle made of colorful abeslang pieces with animal images (sheep, duck) is introduced to the children, and then they are asked to complete the puzzle using their non-dominant hand during the blood sampling procedure.The blood sampling is terminated at the same time by completing abeslang puzzle.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children in the control group are monitored during the blood sampling procedure if their informed consent is obtained by the researcher. They have the routine blood draw procedure, and do not receive any distraction techniques and other pharmacological interventions.
Intervention Type
Other
Intervention Name(s)
PFA
Intervention Description
PFA
Primary Outcome Measure Information:
Title
The level of pain during blood sampling is evaluated using the Wong-Baker FACES Pain Rating Scale
Description
This scale is used to assess the severity of pain in children aged 3 years and above. This numerical rating scale ranges from 0 to 10, indicating emotions ranging from no pain/very happy (0) to crying/hurts worst (10). Higher scores indicate a lower pain tolerance. In this study, this scale is evaluated using personal reports and records from children, their parents, the researcher, and the nurse after the blood sampling procedure.
Time Frame
during the procedure
Secondary Outcome Measure Information:
Title
The level of anxiety is evaluated using the Children Anxiety Meter-State
Description
The Children's Anxiety Meter (CAM-S) assesses children's anxiety in clinical settings and is used prior to medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom and contains horizontal lines at intervals going upwards. Scale scores range from 0 to 10, where higher values represent higher anxiety. Personal reports and records from children, their parents, the researcher, and the nurse, who are asked to mark the scale with a pen, are used to assess the anxiety levels of children regarding blood sampling before and after the procedure.
Time Frame
during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being between 4-6 years old Referring to the pediatric emergency department Having consent and approval from the parent and child to participate in the study Having a necessity for blood testing in the child. Exclusion Criteria: Having visual, hearing, or speech impairment Having chronic or genetic diseases Having intellectual disability Having a history of sedative, narcotic, or analgesic drug use within the past 24 hours Having inflammatory diseases Being classified under the red triage category Unwilling to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Dinç
Phone
+905383555685
Email
fatmadinc@bartin.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Aylin Kurt
Phone
+905382087211
Email
aylinkurt67@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Dinç, PhD Student
Organizational Affiliation
Bartın Unıversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatma Dinç
City
Bartın
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Dinç, PhD Student
Phone
+9005383555685
Email
fatmadinc@bartin.edu.tr
First Name & Middle Initial & Last Name & Degree
Aylin Kurt, PhD
Phone
+9005382087211
Email
aylinkurt67@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Effects of Finger Puppet, Abeslang Puzzle, and Pinwheel on Pain and Anxiety During Blood Sampling Procedures

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