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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904483
• Other study ID #: 2023-BRT-SBF-112234
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: August 20, 2024

Study information

• Verified date: June 2023
• Source: Bartin University
• Contact: Fatma Dinç
• Phone: +905383555685
• Email: fatmadinc[@]bartin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 20, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Anxiety Disorders
• Child, Only
• Pain, Acute

Intervention

Other:
• PFA
PFA

Locations

Country	Name	City	State
Turkey	Fatma Dinç	Bartin

Sponsors (1)

Lead Sponsor	Collaborator
Bartin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	during the procedure
Secondary	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.	during the procedure