Pain and Anxiety of Children During PhlebotomyNCT04513873
The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy
A study testing Equipment to divert the focus of children in people with Pain and Anxiety of Children During Phlebotomy, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain and Anxiety of Children During Phlebotomy
- What is being tested?
- Equipment to divert the focus of children
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2019to 28 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- making a request for the phlebotomy
- being in the 7-12 age group
- having the consent of the parent
- willing to participate in the research
- with the history of invasive procedure
- not using any medication with analgesic effect in the last 12 hours
Show all 9Show fewer
- without any communication barriers of either child or the parent
- with a normal level of consciousness during the process
- without the history of passing out during the phlebotomy
Who cannot join
- not being in the 7-12 age group
- not having the consent of the parent
- not willing to participate in the research
- without the history of invasive procedure
- had medication with analgesic effect in the last 12 hours
- with communication barriers of either child or the parent
- with an abnormal level of consciousness during the process
- with the history of passing out during the phlebotomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manavgat State Hospital
Antalya, Manavgat, 07600
About this study
Official title: The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy On Pain And Anxiety
This study aimed to investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=127) and the control group (n=129). The control group was applied to standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment that looks like a blood tube in front of them during the phlebotomy process to divert their attention from the phlebotomy process to the equipment.
Read the detailed description
The equipment used for the intervention group was designed and developed by the researchers with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a blood tube with a fixed arm on the right and a moving arm on the left with a total height of 80 cm. It has some answers to common questions of parents as well as the key concerns of the children " Will it hurt me?"
- Being tested
- Equipment to divert the focus of children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equipment to divert the focus of childrenDevice
The equipment was placed in an area where the children would be able to see easily during the blood collection process. It was turned on as soon as the children sat on to the chair where the process would take place to divert the focus of the children at the equipment.
| Study group | Role | What they receive |
|---|---|---|
| Equipment Intervention Group | Experimental | The intervention group had equipment that looks like a blood tube in front of them during the blood collection process to divert their attention from the blood collection process to the equipment. This equipment was with a fixed arm on the right and a moving arm on the left with a total height of 80 cm as well as a red light-emitting diode(LED) to stimulate the blood collection. It had some answers to common questions of parents as well as the key concerns of the children like " Will it hurt me?". The equipment was made a musical device by loading the most popular children's songs into its database. Receives: Device: Equipment to divert the focus of children |
| No Intervention Group | No intervention | Standard blood collection procedures were applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Children's Anxiety Level Change
Children's Fear Scale is an instrument with five different face images changing from neutral (0= no fear) to most scared (4= with the most fear) to evaluate the scare level of the children during the procedure.
Measured: Twice ( Immediately after the procedure and 14 days after the procedure)
Secondary outcomes (1)
Revised Face Pain Scale (FPS-R)
The FPS-R is a scale to measure how children feel in their inner world than how their faces look. It is designed on the widely accepted 0-to-10 metric according to the chosen face. "0" equals "No pain" and "10" equals "Very much pain."
Measured: Twice ( During the procedure and 5-10 minutes after the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start18 Jan 2019
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain and Anxiety of Children During PhlebotomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Ciğerci, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513873
- Sponsor's protocol ID
- 2019/37
- Status last verified
- Aug 2020
- First submitted
- 8 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy On Pain And Anxiety
- ClinicalTrials.gov ID
- NCT04513873
- Acronym / sponsor ID
- 2019/37
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 14 Aug 2020 (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 investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=127) and the control group (n=129). The control group was applied to standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment that looks like a blood tube in front of them during the phlebotomy process to divert their attention from the phlebotomy process to the equipment.
Detailed description
The equipment used for the intervention group was designed and developed by the researchers with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a blood tube with a fixed arm on the right and a moving arm on the left with a total height of 80 cm. It has some answers to common questions of parents as well as the key concerns of the children " Will it hurt me?"
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equipment Intervention Group | Experimental | Device: Equipment to divert the focus of childrenThe intervention group had equipment that looks like a blood tube in front of them during the blood collection process to divert their attention from the blood collection process to the equipment. This equipment was with a fixed arm on the right and a moving arm on the left with a total height of 80 cm as well as a red light-emitting diode(LED) to stimulate the blood collection. It had some answers to common questions of parents as well as the key concerns of the children like " Will it hurt me?". The equipment was made a musical device by loading the most popular children's songs into its database. |
| No Intervention Group | No intervention | –Standard blood collection procedures were applied to the control group. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- making a request for the phlebotomy
- being in the 7-12 age group
- having the consent of the parent
- willing to participate in the research
- with the history of invasive procedure
Key exclusion criteria (8 listed)
- not being in the 7-12 age group
- not having the consent of the parent
- not willing to participate in the research
- without the history of invasive procedure
- had medication with analgesic effect in the last 12 hours
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 |
|---|---|---|
| Equipment to divert the focus of childrenThe equipment was placed in an area where the children would be able to see easily during the blood collection process. It was turned on as soon as the children sat on to the chair where the process would take place to divert the focus of the children at the equipment. | Device | Equipment Intervention Group |
Primary outcome
Assessment of Children's Anxiety Level Change
Time frame: Twice ( Immediately after the procedure and 14 days after the procedure)
Children's Fear Scale is an instrument with five different face images changing from neutral (0= no fear) to most scared (4= with the most fear) to evaluate the scare level of the children during the procedure.
1 secondary outcome
Revised Face Pain Scale (FPS-R)
Time frame: Twice ( During the procedure and 5-10 minutes after the procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equipment to divert the focus of children in people with Pain and Anxiety of Children During Phlebotomy, run by Afyonkarahisar Health Sciences 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 14 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of Children's Anxiety Level Change (time frame: Twice ( Immediately after the procedure and 14 days after the procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2020.