PainNCT07152665
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
A study testing Video-Based Education in people with Pain and Fear Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Fear Anxiety, Blood Drawing Procedure
- What is being tested?
- Video-Based Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who will between the ages of 4-7,
- Children who will Blood collection procedure
- Have no cognitive development problems,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
School of Nursing
Izmir, İzmir, (532) 681-4737
About this study
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.
Read the 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.
- Conditions
- Pain, Fear Anxiety, Blood Drawing Procedure
- Being tested
- Video-Based Education
- Keywords
- Children, Pain, Fear, Anxiety, Blood drawing procedure
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Video-Based Education |
| No Intervention: Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Aug 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Bektaş, Dokuz Eylul University
- Investigators
- Murat Bektas, PhD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152665
- Sponsor's protocol ID
- DokuzEU-5
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, it is planned to be shared with other researchers after obtaining institutional permissions when they submit an application and provide their justification.
Publications
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.
PubMed 35513880Akkoyun 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.
PubMed 38147711
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07152665
- Acronym / sponsor ID
- DokuzEU-5
- Conditions
- Pain, Fear Anxiety, Blood Drawing Procedure
- Keywords
- Children, Pain, Fear, Anxiety, Blood drawing procedure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimantel | Experimental | Behavioral: Video-Based EducationParents 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. |
| No Intervention: Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children who will between the ages of 4-7,
- Children who will Blood collection procedure
- Have no cognitive development problems,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Based EducationParents 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. | Behavioural | Experimantel |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publication: PubMed 35513880Andersson 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.
- Results publication: PubMed 38147711Akkoyun 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.
- Individual participant dataSharing planned: Yes. After the study is completed, it is planned to be shared with other researchers after obtaining institutional permissions when they submit an application and provide their justification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Bektas, PhD principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Based Education in people with Pain and Fear Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Means (time frame: Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07152665, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.