The Effect of Therapeutic Play Applied With Puppet

NCT05437146 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/449
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of therapeutic play applied with a hand puppet during blood collection on pain and fear in children. The project is a randomized controlled trial. The study includes children aged 3-6 years who came to the pediatric blood collection unit of Binali Yıldırım University Mengücek Gazi Training and Research Hospital between 01/07/2022 and 01/01/2023. The research sample; children who apply to the unit on the specified dates and meet the research criteria and volunteer to participate in the research. "Survey Form", "Wong-Baker Evaluation of Facial Expressions Scale" and "Child Fear Scale" will be used in data collection.

Conditions

Bloodletting

Outcome Measures

Primary Outcomes (2)

• Wong-Baker Facial Expression Evaluation Scale (WB-FAI)

  The scale was developed in 1981 and was revised in 1983. The scale is used to define pain in the 3-18 age group. The scale indicates that the severity of pain increases from zero to five as you go from left to right. Facial expressions are included under the numbers to describe the severity of pain. It consists of 6 faces in total. While the first smiling facial expression expresses the pain-free state, the crying facial expression at the end indicates the most severe pain intensity. While applying the scale, the child is told to choose the facial expression that best describes his feelings at the moment. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.

  9 MONTHS

• Child Fear Scale (CFS):

  The scale was developed in 2011. The Child Fear Scale is used to determine the level of fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).

  9 MONTHS

Study Arms (2)

Puppet

EXPERIMENTAL

pain and fear

Behavioral: puppet

control

NO INTERVENTION

not pain and fear

Interventions

puppet BEHAVIORAL

pain and fear during blood collection

Puppet

Eligibility Criteria

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

You may qualify if:

• be between 3-6 years old
• Not having a disability related to developmental areas
• Not taking analgesics within 24 hours before application
• Being with the mother or father of the child during the procedure

You may not qualify if:

• Not between 3-6 years old
• Having a disability related to developmental areas
• Taking analgesics within 24 hours before admission
• Not being with the mother or father of the child during the procedure

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Study Officials

• ARZU SARIALİOĞLU, PHD

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 29, 2022
• Study Start: June 19, 2022
• Primary Completion: October 27, 2022
• Study Completion: December 28, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)