The Effect of Distraction During Blood Collection on the Fear and Anxiety Levels of Children

NCT06476418 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/272
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The project is a randomized controlled trial. The population of the research will consist of children aged 4-6 years old who applied to Erzincan Mengücek Gazi Training and Research Hospital Pediatric Blood Collection Unit between June 2024 and June 2025. The sample of the research will consist of children who apply to the blood collection unit on the specified dates and meet the research criteria and volunteer to participate in the research. "Survey Form", "Child Fear Scale" and "Child Anxiety Scale-State" will be used to collect data.

Conditions

Fear Anxiety

Outcome Measures

Primary Outcomes (2)

• Child Fear Scale

  The scale was developed to measure fear in children undergoing painful medical procedures. The scale is a 0-4 scale showing five faces ranging from a neutral expression (0 = no concern) to a fearful face (4 = severe concern).

  6 months

• Child Anxiety Scale - State

  The Children's Anxiety Scale State (CAS-D) scale, which resembles a thermometer with horizontal lines, is scored as 0-10. It is a scale developed for children aged 4-10. When introducing the scale to the child, it is said that there is no anxiety, that the anxiety increases as it goes up, and that the anxiety level is very high at the top. The child is then asked to put a line on the part that shows how anxious or angry he or she is.

  6 months

Study Arms (2)

distraction

EXPERIMENTAL

Questionnaires and scales will be filled out by the researcher 5 minutes before blood collection. Only routine applications will be made. The scales will be filled again 5 minutes after blood collection.

Behavioral: distraction

control

NO INTERVENTION

Questionnaires and scales will be filled out by the researcher 5 minutes before blood collection. The child will be allowed to play with the liquid moving, timed fountain toy 3 minutes before blood collection. During the process, the child will continue to play with the toy. The scales will be filled again 5 minutes after blood collection.

Interventions

distraction BEHAVIORAL

Questionnaires and scales will be filled out by the researcher 5 minutes before blood collection. The child will be allowed to play with the liquid moving, timed fountain toy 3 minutes before blood collection. During the process, the child will continue to play with the toy. The scales will be filled again 5 minutes after blood collection.

distraction

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being between 4-6 years old
• Taking blood with a single attempt
• Being admitted to the hospital for an acute reason
• Children accompanied by their mother or father during the procedure

You may not qualify if:

• Not having any disabilities related to developmental areas
• No history of sedative, analgesic or narcotic substance use within 24 hours before application
• Not having a chronic disease

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Osteogenesis, Distraction

Intervention Hierarchy (Ancestors)

Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Study Design

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

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: May 3, 2024
• Primary Completion: December 29, 2024
• Study Completion: March 6, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)