Pain, ProceduralNCT05064657
The Effect of Two Method to Reducing Pain and Fear During Draw Blood From Children
A study testing Bubble blowing method in people with Pain, Procedural and Pain Management, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effects of two different distraction methods on reducing pain and fear during blood collection from children. The study was conducted between January 2020 and May 2021. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural, Pain Management, Child, Only
- What is being tested?
- Bubble blowing method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2020to 31 Oct 2020
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between the ages of 6-12
- The child's willingness to voluntarily participate in the study
- Parent's willingness to participate in the study voluntarily
- Parent and child can speak Turkish
Who cannot join
- The child has a disease that causes chronic pain
- The child has a hearing or visual impairment
- The child has a mental or neurological disability
- The child has used drugs that will create an analgesic effect in the last 24 hours before the application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Different Applications on Reducing Pain and Fear During Draw Blood From Children
This study was conducted to evaluate the effects of two different distraction methods on reducing pain and fear during blood collection from children.
The study was conducted between January 2020 and May 2021.
Read the detailed description
The study was a pretest-posttest, parallel group randomized controlled experimental design.
H0: The pain and fear mean scores of the intervention group, in which the distraction method (ball squeezing and blowing bubbles) was applied during the blood collection process, was not different from the control group.
The study was carried out with the participation of 111 children aged 6-12 years and their parents, who underwent blood collection in the emergency department of a state hospital.
Children were randomly assigned to blowing bubbles (n:37), ball squeezing (n:37) and control (n:37) groups. Bubble blowing and ball squeezing methods were used to distract attention during the blood collection process. Data were collected with Child and Family Information Form, Wong Baker Faces Pain Scale, Child Fear Scale. Pretest and posttest measurements were recorded separately by the child, parent and researcher. Descriptive statistics, Chi-square test, one-way analysis of variance, Tamhane's T2 test, t test for dependent groups were used in the analysis of the data. The statistical significance of the results was taken as p<0,05
- Conditions
- Pain, Procedural, Pain Management, Child, Only
- Being tested
- Bubble blowing method
- Keywords
- pain, procedural, fear, child, distraction methods
- Medical subject headings
- Pain, Procedural, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble blowing methodProcedure or surgery
Also called Ball squeezing method
The investigators were used "Bubble blowing method" and "ball squeezing method".
To child were used a ball squeezing method during the blood collection process.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental Group (ball squeezing) The group were used a ball squeezing method during the blood collection process.
The children were given a ball during the blood draw and told to tighten and loosen it. Receives: Procedure: Bubble blowing method |
| Active Comparator | Active comparator | Active Comparator ( bubble blowing) The group were used a bubble blowing method during the blood collection process. During the blood collection process, the children were asked to blow bubbles by giving the apparatus inside the foam bubble to their free arm. Receives: Procedure: Bubble blowing method |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong Baker Pain Faces Scale mean score
Wong-Baker Pain Faces Scale is widely used with people ages three and older, not limited to children. This self-assessment tool must be understood by the patient, so they are able to choose the face that best illustrates the physical pain they are experiencing. It is a tool to be used by a third person, parents, healthcare professionals, or caregivers, to assess the patient's pain. The scale is 0-10 scale. The six illustrated faces on the cards show a range of emotions, from a smiling face (0 'no pain) to a crying face (10 "worst pain"). 0 indicates no pain, 10 indicates the most severe pain. It defines the child's pain level before and after the blood collection.
Measured: First ten minute
Children's Fear Scale mean score
Children's Fear Scale is a scale of 0-4 showing five faces ranging from a neutral expression (0 = no concern) to the feared face (4 = severe anxiety). A score of 0 indicates no fear and a score of 4 indicates extremely fearful. Defines the change of fear level before and after during the blood collection.
Measured: First ten minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start20 Jul 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ProceduralStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Model description
- Parallel Assignment First sub purpose was designed as parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Taş Arslan, Selcuk University
- Investigators
- Fatma Tas Arslan, Prof., Study director, Selcuk UniversityNeşe Oluç, Msc, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064657
- Sponsor's protocol ID
- SelcukU-01-2020
- Status last verified
- Oct 2021
- First submitted
- 29 Jun 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oluc N, Tas Arslan F. The effect of two different methods on reducing the pain and fear during phlebotomy to children: A randomized controlled trial. Int Emerg Nurs. 2024 Feb;72:101386. doi: 10.1016/j.ienj.2023.101386. Epub 2023 Nov 18.
PubMed 37984025
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Applications on Reducing Pain and Fear During Draw Blood From Children
- ClinicalTrials.gov ID
- NCT05064657
- Acronym / sponsor ID
- SelcukU-01-2020
- Conditions
- Pain, Procedural, Pain Management, Child, Only
- Keywords
- pain, procedural, fear, child, distraction methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 1 Oct 2021 (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 was conducted to evaluate the effects of two different distraction methods on reducing pain and fear during blood collection from children.
The study was conducted between January 2020 and May 2021.
Detailed description
The study was a pretest-posttest, parallel group randomized controlled experimental design.
H0: The pain and fear mean scores of the intervention group, in which the distraction method (ball squeezing and blowing bubbles) was applied during the blood collection process, was not different from the control group.
The study was carried out with the participation of 111 children aged 6-12 years and their parents, who underwent blood collection in the emergency department of a state hospital.
Children were randomly assigned to blowing bubbles (n:37), ball squeezing (n:37) and control (n:37) groups. Bubble blowing and ball squeezing methods were used to distract attention during the blood collection process. Data were collected with Child and Family Information Form, Wong Baker Faces Pain Scale, Child Fear Scale. Pretest and posttest measurements were recorded separately by the child, parent and researcher. Descriptive statistics, Chi-square test, one-way analysis of variance, Tamhane's T2 test, t test for dependent groups were used in the analysis of the data. The statistical significance of the results was taken as p<0,05
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment First sub purpose was designed as parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Bubble blowing methodExperimental Group (ball squeezing) The group were used a ball squeezing method during the blood collection process. The children were given a ball during the blood draw and told to tighten and loosen it. |
| Active Comparator | Active comparator | Procedure: Bubble blowing methodActive Comparator ( bubble blowing) The group were used a bubble blowing method during the blood collection process. During the blood collection process, the children were asked to blow bubbles by giving the apparatus inside the foam bubble to their free arm. |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being between the ages of 6-12
- The child's willingness to voluntarily participate in the study
- Parent's willingness to participate in the study voluntarily
- Parent and child can speak Turkish
Key exclusion criteria (4 listed)
- The child has a disease that causes chronic pain
- The child has a hearing or visual impairment
- The child has a mental or neurological disability
- The child has used drugs that will create an analgesic effect in the last 24 hours before the application
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 |
|---|---|---|
| Bubble blowing methodAlso: Ball squeezing methodThe investigators were used "Bubble blowing method" and "ball squeezing method". To child were used a ball squeezing method during the blood collection process. | Procedure or surgery | Active Comparator, Experimental Group |
Primary outcome
Wong Baker Pain Faces Scale mean score
Time frame: First ten minute
Wong-Baker Pain Faces Scale is widely used with people ages three and older, not limited to children. This self-assessment tool must be understood by the patient, so they are able to choose the face that best illustrates the physical pain they are experiencing. It is a tool to be used by a third person, parents, healthcare professionals, or caregivers, to assess the patient's pain. The scale is 0-10 scale. The six illustrated faces on the cards show a range of emotions, from a smiling face (0 'no pain) to a crying face (10 "worst pain"). 0 indicates no pain, 10 indicates the most severe pain. It defines the child's pain level before and after the blood collection.
Children's Fear Scale mean score
Time frame: First ten minute
Children's Fear Scale is a scale of 0-4 showing five faces ranging from a neutral expression (0 = no concern) to the feared face (4 = severe anxiety). A score of 0 indicates no fear and a score of 4 indicates extremely fearful. Defines the change of fear level before and after during the blood collection.
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 28 Oct 2021.
- Derived from this study: PubMed 37984025Oluc N, Tas Arslan F. The effect of two different methods on reducing the pain and fear during phlebotomy to children: A randomized controlled trial. Int Emerg Nurs. 2024 Feb;72:101386. doi: 10.1016/j.ienj.2023.101386. Epub 2023 Nov 18.
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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.
Fatma Tas Arslan, Prof. study director
Selcuk University
Neşe Oluç, Msc principal investigator
Selcuk 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 Bubble blowing method in people with Pain, Procedural and Pain Management, run by Selcuk 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 4 inclusion and 4 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 28 Oct 2021. 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?
Wong Baker Pain Faces Scale mean score (time frame: First ten minute). The study lists 2 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 NCT05064657, which also lists 1 linked publication.
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 28 Oct 2021.