Blood Drawing Procedure, Fear Anxiety, Pain
Conditions
Keywords
Children, Pain, Fear, Anxiety, Blood drawing procedure
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.
Interventions
BEHAVIORALVideo-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.
Sponsors
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed