NCT07044713

Brief Summary

The aim of this study was to compare a hand puppet with image viewing and a coloring book for children in reducing children's pain and fear during blood collection.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 24, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

blood collectionfearchildpainhand puppetTracing and Painting the Image

Outcome Measures

Primary Outcomes (3)

  • Patient Identification Form

    It is a form consisting of 7 questions in total, including the child's age, gender, previous hospital experience, if any, how many times the child has been hospitalized, whether the parents have prepared for the blood collection process beforehand, experience of having blood drawn in the last six months, and reactions to the blood collection process. It was prepared by researchers in accordance with the literature.

    Baseline

  • Wong Baker Face Pain Scale

    Children between the ages of three and eight can express many pain areas and their severity. In this study, the Wong-Baker Pain Inventory will be used in combination with the Visual Analog Scale, since face scales are more appropriate. The Wong Baker Face Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children between the ages of three and eighteen. The scale includes facial expressions that the child can enjoy and enjoy. For this reason, it has been stated that it gives more accurate results. The scale has scores of "0", "2", "4", "6", "8", and "10". A score of "0" indicates no pain and a score of "10" indicates the highest pain. This scale does not have a Cronbach's alpha score. It has been reported that reliability studies have not been conducted on such scales. In our study, the child will be shown the facial expressions on the pain scale and asked which one it is, and the score co

    Baseline and up to 4 weeks

  • Child Fear Scale

    The Turkish validity of this scale, developed by McMurtry and colleagues, was done by Gerçeker and colleagues. The changes in the facial muscles of the frightened expression were drawn by a graphic artist from a photograph of a frightened face. It can be used by the parent, child or researcher to scale the child's fear. The scale, which has facial expressions scored from 0 to 4, is shown to the child. A score of 4 indicates that the child is very frightened, and a score of 0 indicates that the child is not frightened. It is accepted that a score of "0" indicates a neutral expression (no fear), a score of "1" indicates a very low level of fear, a score of "2" indicates a little fear, a score of "3" indicates a greater level of fear, and a score of 4 indicates that the level of fear is at the highest level. This scale can be used to measure fear before and during the procedure. In our study, the child will be shown the facial expressions on the

    Baseline and up to 4 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Routine clinical care will be applied to the control group. No action will be taken.

Experimental Group

EXPERIMENTAL

Before blood collection, the child will be shown games with hand puppets and will be asked to watch the image and color with the Coloring Book.

Other: Hand PuppetOther: The Visual Viewing and Coloring Book

Interventions

Children who come to the hospital's blood collection unit and meet the research criteria will be randomly assigned to the hand puppet group. The scales will be filled out by the nurse and the child five minutes before the blood collection. The researcher will benefit from the experiences of the child development specialist and preschool teacher before the research on puppet scenarios. In the interview room outside the blood collection unit, the child's parent will be asked to tell the researcher about the things the child enjoys and likes. The researcher will show the child puppet characters on various themes and the child will be asked to choose the puppet character he/she wants before the blood collection. The puppet scenarios will be improvised in light of the information received from the child's mother and father during the demonstration and will be shaped according to the child's wishes. In this way, the child will turn the scary hospital environment into an entertaining environm

Experimental Group

Children who come to the hospital's blood collection unit and meet the research criteria will be randomly assigned to the coloring group. The scales will be filled out by the nurse and the child five minutes before the blood is drawn. The Visual Viewing and Coloring Book consists of pictures that require coloring. The children will be given a book before the blood is drawn and will be asked to draw or color a picture as they prefer during the procedure. The fear scale will be assessed by the nurse and the child five minutes before, during, and five minutes after the procedure. The pain scale will be assessed by the nurse and the child during and five minutes after the procedure. The child will be shown the facial expressions on both the fear scale and the pain scale and asked which one it is, and the score corresponding to the facial expression he/she indicates will be recorded. Mothers will stay with their children during the treatment proce

Experimental Group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between 3-6 years old
  • Taking blood samples at once
  • No visual-auditory and speech disorders
  • Being open to communication and
  • Being accompanied by a parent.

You may not qualify if:

  • Having a chronic disease
  • Having a visual-auditory and speech disorder
  • History of sedative, analgesic or narcotic substance use within 24 hours before admission
  • Children whose parents do not agree to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilis Prof. Dr. Alaeddin Yavaşca State Hospital

Kilis, Central, 79000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Oluc T, Sarialioglu A. The effect of a hand puppet-based therapeutic play for preschool children on the fear and pain associated with blood collection procedure. J Pediatr Nurs. 2023 Sep-Oct;72:e80-e86. doi: 10.1016/j.pedn.2023.06.012. Epub 2023 Jun 15.

    PMID: 37330277BACKGROUND

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gamze AKAY, 1

    Artvin Coruh University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 1, 2025

Study Start

July 1, 2025

Primary Completion

October 1, 2025

Study Completion

January 1, 2026

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations