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

NCT07152665 | Active Not Recruiting

• 1 other identifier: DokuzEU-5
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Fear Anxiety; Blood Drawing Procedure

Keywords

Children; Pain; Fear; Anxiety; Blood drawing procedure

Outcome Measures

Primary Outcomes (3)

• Pain Means

  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.

  Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt

• Anxiety Means

  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.

  Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt

• Fear Means

  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.

  Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt

Study Arms (2)

Experimantel

EXPERIMENTAL

Parents of children in the intervention group will inform that the educational videos used in the study aim to reduce the child's pain, fear, and anxiety. An informational video willprepare by the researchers will show to the parents, while an age-appropriate video explaining the blood collection process will shown to the children. The video content wil structured in accordance with the existing literature Characters featured in the parent and child videos will select, and separate scenarios for each group will developed by the researchers. Video recordings will conduct outside of working hours in the blood collection unit, accompanied by a professional cameraman. To evaluate the feasibility and comprehensibility of the videos, a pilot study will conduct with five children and their parents who will not included in the main study. The parent video addressed the attitudes and behaviors that parents should exhibit before, during, and after the blood collection procedure.

Behavioral: Video-Based Education

No Intervention: Control Group

NO INTERVENTION

No intervention

Interventions

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.

Experimantel

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

School of Nursing

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

Location

Related Publications (2)

• Andersson V, Bergman S, Henoch I, Simonsson H, Ahlberg K. Pain and pain management in children and adolescents receiving hospital care: a cross-sectional study from Sweden. BMC Pediatr. 2022 May 5;22(1):252. doi: 10.1186/s12887-022-03319-w.

  PMID: 35513880 BACKGROUND

• Akkoyun S, Arslan FT, Sekmenli T. The effect of written document in perioperative information on the anxiety level and family-centered care of parents of children undergoing ambulatory surgery: A randomized controlled trial. J Pediatr Nurs. 2024 Mar-Apr;75:108-115. doi: 10.1016/j.pedn.2023.12.012. Epub 2023 Dec 25.

  PMID: 38147711 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Murat Bektas, PhD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants in the study will assign using a stratified randomization method. Strata will create based on gender (two groups: female and male) and age (four groups: 4, 5, 6, and 7 years), and random sampling will perform within each stratum. The matching of the child with the nurse performing the blood draw will do randomly using the institution's routine queue management system. A nurse not involved in the study will assign each child to group and nurse who performing the blood draw based on their arrival number in the institution's blood draw queue system according to the previously determined randomization scheme. After the study is completed, the group names will be blinded, allowing analyses to be conducted without revealing the group names to the statistician.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Model Details: The population will consist of children between the ages of 4-7 who presented to Pediatric Phlebotomy Unit of the Central Laboratory at a university hospital in Turkey. The sample group will determined using stratified randomization based on strata created according to gender (female/male) and age (4, 5, 6, and 7 years). To calculate the required sample size, a repeated measures analysis of variance (ANOVA) was conducted using the G\*Power software; the significance level was set at 0.01, statistical power at 99%, and a medium effect size was assumed. Based on these calculations, a minimum of 34 participants per group was required. Considering a potential 10% dropout rate, it was decided that each group would consist of 38 participants.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)