The Effect of Video-Based Educational Content for Parents and Children on Anxiety, Fear, and Pain During Blood Draw in Children: A Randomized Controlled Trial

Not Applicable

Active, not recruiting

• Conditions: Pain; Fear Anxiety; Blood Drawing Procedure

• Registration Number: NCT07152665
• Lead Sponsor: Dokuz Eylul University

Brief Summary

This study aimed to examine the effect of video-based educational content prepared for parents and children on anxiety, fear, and pain levels experienced by children aged 4-7 during venipuncture procedures.

Detailed Description

This study aim to examine the effect of video-based educational content prepared for parents and children on anxiety, fear, and pain levels experienced by children aged 4-7 during venipuncture procedures.The study a single-centre, randomized controlled trial. The study will conduct in the pediatric phlebotomy unit of a university hospital's central laboratory in Turkey.

This randomized controlled trial will included 80 children aged 4-7, randomly assigned to intervention and control groups. The control group will receive routine clinical care before, during, and after venipuncture. In the intervention group, children and their parents will shown video-based educational content prior to the procedure. Data collection tools included a Child and Family Information Form, the Children's pain, Fear, and the Child Anxiety Scale. The normality of fear, anxiety, and pain scale scores will evaluate with the Shapiro-Wilk test. Repeated measures analysis of variance (ANOVA) will applied to compare scale scores across groups and time points. Within-group comparisons will conduct using one-way repeated measures ANOVA, while between-group differences at each time point were assessed with independent samples t-tests.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2025-10-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Children who will between the ages of 4-7,
• Children who will Blood collection procedure
• Have no cognitive development problems,

Exclusion Criteria

• Children who will not want to participate in the study,
• Leave the research during the study,
• Have an audio-visual disorder that could prevent the use of video

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Means	Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt	Pain score will be measured with the Children's Pain Scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's pain increases. In this study, if children get high scores from the pianscale, it will be determined that they have high procedural pain. Getting a low score from the scale will indicate that their pain about the procedure is low.
Anxiety Means	Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt	Anxiety score will be measured with the Child Fear and Anxiety Scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's anxiety increases. In this study, if children get high scores from the anxiety section of the scale, it will be determined that they have high procedural anxiety. Getting a low score from the scale will indicate that their anxiety about the procedure is low.
Fear Means	Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt	Fear score will be measured with the Children's fear and anxiety scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's fear increases. In this study, if children score high on the fear section of the scale, it will be determined that their fear of the procedure is high. A low score on the scale will indicate that fears about the procedure are low.

Trial Locations

Locations (1)

School of Nursing; Izmir, İzmir, Turkey (Türkiye)