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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain Fear Anxiety Blood Drawing Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Experimantel

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.

Group Type EXPERIMENTAL

Video-Based Education

Intervention Type 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.

No Intervention: Control Group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Video-Based Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes