Child, OnlyNCT05483699
Efficiency of Three Different Methods in Reducing Pain in Children During Intravenous Cannulation
A study testing Squeezing a ball, Blowing bubbles and Kaleidoscope in people with Child, Only, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study investigates the effects of squeezing a soft ball, using a kaleidoscope, or blowing bubbles during intravenous cannulation on the pain and fear of children between the ages of 4 and 6. Design and Methods: This study is a randomised controlled study. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Child, Only
- What is being tested?
- Squeezing a ball, Blowing bubbles and Kaleidoscope
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2021to 5 Feb 2022
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parents who agreed to participate in the study
Who cannot join
- visually impaired child
- mentally retarded child
- speech impaired children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficiency of Three Different Methods in Reducing Pain and Fear in Children During Intravenous Cannulation: A Randomised Controlled Study
Purpose: This study investigates the effects of squeezing a soft ball, using a kaleidoscope, or blowing bubbles during intravenous cannulation on the pain and fear of children between the ages of 4 and 6.
Design and Methods: This study is a randomised controlled study. In the study, there were 30 children in the soft ball group, 30 children in the kaleidoscope group, 30 children in the bubbles group, and 30 children in the control group.
Read the detailed description
15 minutes before the intravenous cannulation procedure, the second researcher interviewed the parents and the children in squeezing soft ball, kaleidoscope, blowing bubbles and control groups separately and filled in descriptive information form and Children's Fear Scale. After randomization, the second researcher, the child and the parent went to the blood collection room for the procedure. Children in the Kaleidoscope group were given the kaleidoscope before intravenous cannulation and they were shown how to use it. The children were told to look at the kaleidoscope during the procedure until the procedure ended. The children in the squeezing soft ball group were given the ball before the procedure. They were told to squeeze and loosen the ball with the hand that was not used for the procedure while intravenous cannula was being inserted. The children in the blowing bubble group were shown the bubble blower before intravenous cannulation and they were told how bubbles were formed and how they would blow. During intravenous cannulation, the child blew the blower. Routine procedures were applied on the children in the control group without any interventions. Inserting the intravenous cannula took 3-5 minutes. The procedure was carried out in the same room by the same nurse for four of the groups. After the intravenous cannulation procedure ended, a researcher and parents filled in Faces Pain Scale-Revised and Children's Fear Scale separately and independently to find out the level of pain and fear experienced by the child during the procedure.
- Conditions
- Child, Only
- Being tested
- Squeezing a ball, Blowing bubbles, Kaleidoscope
- Keywords
- Blowing bubbles, child, fear, kaleidoscope, pain, squeezing soft ball
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squeezing a ballOther
The children in the squeezing soft ball group were given the ball before the procedure. They were told to squeeze and loosen the ball with the hand that was not used for the procedure while intravenous cannula was being inserted.
Blowing bubblesOther
The children in the blowing bubble group were shown the bubble blower before intravenous cannulation and they were told how bubbles were formed and how they would blow. During intravenous cannulation, the child blew the blower
KaleidoscopeOther
Children in the Kaleidoscope group were given the kaleidoscope before intravenous cannulation and they were shown how to use it. The children were told to look at the kaleidoscope during the procedure until the procedure ended
| Study group | Role | What they receive |
|---|---|---|
| Squeezing a ball during intravenous cannulation reduces the child's pain and fear. | Experimental | The soft ball has a diameter of about 8-10 cm and can return to its old form when it is squeezed. Receives: Other: Squeezing a ball |
| Using a kaleidoscope during intravenous cannulation reduces the child's pain and fear. | Experimental | Kaleidoscope includes shapes of flowers and mirrors in the shape of triangle placed with an angle of 600. While rotating one of the cylinders, various shapes and colourful eyes are formed when viewed with one eye. When the kaleidoscope is rotated, the patterns look different all the time because the colourful parts are moving, attracting the child's attention. Receives: Other: Kaleidoscope |
| Blowing bubbles during intravenous cannulation reduces the child's pain and fear. | Experimental | Children in this group were shown bubble blower before intravenous cannulation and they were shown how bubbles formed and how to blow. Children blew bubbles during intravenous cannulation Receives: Other: Blowing bubbles |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing fear during intravenous cannula
Children's Fear Scale: The scale was developed by McMurtry et al. to find out the anxiety levels of children between 4 and 10 years of age (McCarthy et al., 2010). There are five face pictures in the scale. Anxiety level is scored between "0 and 4". 0 indicates "no anxiety", while a scared face is scored 4 and indicates "too much anxiety".
After the intravenous cannulation procedure ended, a researcher and parents filled Children's Fear Scale separately and independently to find out fear experienced by the child during the procedure.
Measured: 3-5 minutes.
assessing pain during intravenous cannula
Faces Pain Scale-Revised: The scale developed by Bieri et al. is used to evaluate the pain levels of children between the ages of 4 and 17 (Bieri, Reeve, Champion, Addicoat, \& Ziegler, 1990). There are pictures of 6 faces in the scale. Level of pain is evaluated as "0,2,4,6,8,10". The face on the leftmost side is given a score of 0 and interpreted as "no pain", while the face on the rightmost side is given a score of 10 and interpreted as "a lot of pain". Pain severity increases as score increases.
After the intravenous cannulation procedure ended, a researcher and parents filled Faces Pain Scale separately and independently to find out pain experienced by the child during the procedure.
Measured: 3-5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start3 Jul 2021
- Primary completion5 Feb 2022
- Study completion5 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİDEM COŞKUN ŞİMŞEK, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483699
- Sponsor's protocol ID
- intravenous cannulation
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 2 Aug 2022
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Three Different Methods in Reducing Pain and Fear in Children During Intravenous Cannulation: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05483699
- Acronym / sponsor ID
- intravenous cannulation
- Conditions
- Child, Only
- Keywords
- Blowing bubbles, child, fear, kaleidoscope, pain, squeezing soft ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 5 Feb 2022 (actual)
- Study completion
- 5 Feb 2022 (actual)
- First posted
- 2 Aug 2022 (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.
Purpose: This study investigates the effects of squeezing a soft ball, using a kaleidoscope, or blowing bubbles during intravenous cannulation on the pain and fear of children between the ages of 4 and 6.
Design and Methods: This study is a randomised controlled study. In the study, there were 30 children in the soft ball group, 30 children in the kaleidoscope group, 30 children in the bubbles group, and 30 children in the control group.
Detailed description
15 minutes before the intravenous cannulation procedure, the second researcher interviewed the parents and the children in squeezing soft ball, kaleidoscope, blowing bubbles and control groups separately and filled in descriptive information form and Children's Fear Scale. After randomization, the second researcher, the child and the parent went to the blood collection room for the procedure. Children in the Kaleidoscope group were given the kaleidoscope before intravenous cannulation and they were shown how to use it. The children were told to look at the kaleidoscope during the procedure until the procedure ended. The children in the squeezing soft ball group were given the ball before the procedure. They were told to squeeze and loosen the ball with the hand that was not used for the procedure while intravenous cannula was being inserted. The children in the blowing bubble group were shown the bubble blower before intravenous cannulation and they were told how bubbles were formed and how they would blow. During intravenous cannulation, the child blew the blower. Routine procedures were applied on the children in the control group without any interventions. Inserting the intravenous cannula took 3-5 minutes. The procedure was carried out in the same room by the same nurse for four of the groups. After the intravenous cannulation procedure ended, a researcher and parents filled in Faces Pain Scale-Revised and Children's Fear Scale separately and independently to find out the level of pain and fear experienced by the child during the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Squeezing a ball during intravenous cannulation reduces the child's pain and fear. | Experimental | Other: Squeezing a ballThe soft ball has a diameter of about 8-10 cm and can return to its old form when it is squeezed. |
| Using a kaleidoscope during intravenous cannulation reduces the child's pain and fear. | Experimental | Other: KaleidoscopeKaleidoscope includes shapes of flowers and mirrors in the shape of triangle placed with an angle of 600. While rotating one of the cylinders, various shapes and colourful eyes are formed when viewed with one eye. When the kaleidoscope is rotated, the patterns look different all the time because the colourful parts are moving, attracting the child's attention. |
| Blowing bubbles during intravenous cannulation reduces the child's pain and fear. | Experimental | Other: Blowing bubblesChildren in this group were shown bubble blower before intravenous cannulation and they were shown how bubbles formed and how to blow. Children blew bubbles during intravenous cannulation |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- parents who agreed to participate in the study
Key exclusion criteria (3 listed)
- visually impaired child
- mentally retarded child
- speech impaired children
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 |
|---|---|---|
| Squeezing a ballThe children in the squeezing soft ball group were given the ball before the procedure. They were told to squeeze and loosen the ball with the hand that was not used for the procedure while intravenous cannula was being inserted. | Other | Squeezing a ball during intravenous cannulation reduces the child's pain and fear. |
| Blowing bubblesThe children in the blowing bubble group were shown the bubble blower before intravenous cannulation and they were told how bubbles were formed and how they would blow. During intravenous cannulation, the child blew the blower | Other | Blowing bubbles during intravenous cannulation reduces the child's pain and fear. |
| KaleidoscopeChildren in the Kaleidoscope group were given the kaleidoscope before intravenous cannulation and they were shown how to use it. The children were told to look at the kaleidoscope during the procedure until the procedure ended | Other | Using a kaleidoscope during intravenous cannulation reduces the child's pain and fear. |
Primary outcome
assessing fear during intravenous cannula
Time frame: 3-5 minutes.
Children's Fear Scale: The scale was developed by McMurtry et al. to find out the anxiety levels of children between 4 and 10 years of age (McCarthy et al., 2010). There are five face pictures in the scale. Anxiety level is scored between "0 and 4". 0 indicates "no anxiety", while a scared face is scored 4 and indicates "too much anxiety". After the intravenous cannulation procedure ended, a researcher and parents filled Children's Fear Scale separately and independently to find out fear experienced by the child during the procedure.
assessing pain during intravenous cannula
Time frame: 3-5 minutes.
Faces Pain Scale-Revised: The scale developed by Bieri et al. is used to evaluate the pain levels of children between the ages of 4 and 17 (Bieri, Reeve, Champion, Addicoat, \& Ziegler, 1990). There are pictures of 6 faces in the scale. Level of pain is evaluated as "0,2,4,6,8,10". The face on the leftmost side is given a score of 0 and interpreted as "no pain", while the face on the rightmost side is given a score of 10 and interpreted as "a lot of pain". Pain severity increases as score increases. After the intravenous cannulation procedure ended, a researcher and parents filled Faces Pain Scale separately and independently to find out pain experienced by the child during 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 2 Aug 2022.
- 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 Squeezing a ball, Blowing bubbles and Kaleidoscope in people with Child, Only, run by Firat 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 1 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: finished, as of the sponsor's last update on 2 Aug 2022. 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?
assessing fear during intravenous cannula (time frame: 3-5 minutes.). 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?
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 2 Aug 2022.