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NCT Number: NCT07152665

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pain Anxiety Disorders Blood Drawing Procedure Fear Anxiety Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing

Izmir, İzmir, (532) 681-4737, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video-based education

Behavioral

Parents of children in the intervention group were informed that the educational videos used in the study aimed to reduce the child's pain, fear, and anxiety.

Primary outcomes

  1. Pain Means

    Time frame: 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.

  2. Anxiety Means

    Time frame: 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.

  3. Fear Means

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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