PainNCT05301088
Pain and Fear of Venous Blood Collection in Children
A study testing Chocolate Scent in people with Pain and Fear, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Nurses are in the position of primary health care provider in relieving children's pain and fears of bloodletting in the wards where they work. As a result of this study, it is aimed to encourage nurses to apply non-pharmacological interventions during painful medical procedures, to facilitate the provision of… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Chocolate Scent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Jun 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-12 age group,
- children who need blood drawn for any reason
- have no disease that can cause chronic pain,
- no olfactory disorder
- no mental or neurological problems
- able to communicate
- speaks Turkish
Who cannot join
- those who did not give consent to the research by both the child and the parent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chocolate Smell and Stress Ball on Pain and Fear in Venous Blood Collection in Children
Nurses are in the position of primary health care provider in relieving children's pain and fears of bloodletting in the wards where they work. As a result of this study, it is aimed to encourage nurses to apply non-pharmacological interventions during painful medical procedures, to facilitate the provision of necessary and different means of distraction to blood collection services, and to contribute to the development of in-house health policies and the preparation of appropriate clinical guides and to add an innovative perspective.
- Being tested
- Chocolate Scent
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chocolate ScentOther
Also called Stress Ball
Chocolate Scent:Children in this group will be given chocolate scent sniffing as a non-pharmacological distraction method.
Stress Ball:Stress ball squeezing will be used as a non-pharmacological distraction method for children in this group.
| Study group | Role | What they receive |
|---|---|---|
| Chocolate Scent | Experimental | Not described Receives: Other: Chocolate Scent |
| Stress Ball | Experimental | Not described Receives: Other: Chocolate Scent |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Faces Pain Rating Scale
Measured: 12 week
Child Fear Scale
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Apr 2022
- Primary completion30 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- MSc Eylem Nazan KAPAN
- Responsible party
- Principal investigator, Türkan Kadiroğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301088
- Sponsor's protocol ID
- B.30.2.ATA.O.O.0l 0/184
- Status last verified
- Jul 2022
- First submitted
- 19 Mar 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chocolate Smell and Stress Ball on Pain and Fear in Venous Blood Collection in Children
- ClinicalTrials.gov ID
- NCT05301088
- Acronym / sponsor ID
- B.30.2.ATA.O.O.0l 0/184
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- MSc Eylem Nazan KAPAN
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Mar 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.
Nurses are in the position of primary health care provider in relieving children's pain and fears of bloodletting in the wards where they work. As a result of this study, it is aimed to encourage nurses to apply non-pharmacological interventions during painful medical procedures, to facilitate the provision of necessary and different means of distraction to blood collection services, and to contribute to the development of in-house health policies and the preparation of appropriate clinical guides and to add an innovative perspective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chocolate Scent | Experimental | Other: Chocolate Scent |
| Stress Ball | Experimental | Other: Chocolate Scent |
| Control | No intervention | – |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 6-12 age group,
- children who need blood drawn for any reason
- have no disease that can cause chronic pain,
- no olfactory disorder
- no mental or neurological problems
Key exclusion criteria (1 listed)
- those who did not give consent to the research by both the child and the parent
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 |
|---|---|---|
| Chocolate ScentAlso: Stress BallChocolate Scent:Children in this group will be given chocolate scent sniffing as a non-pharmacological distraction method. Stress Ball:Stress ball squeezing will be used as a non-pharmacological distraction method for children in this group. | Other | Chocolate Scent, Stress Ball |
Primary outcome
Wong-Baker Faces Pain Rating Scale
Time frame: 12 week
Child Fear Scale
Time frame: 12 week
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 29 Jul 2022.
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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 Chocolate Scent in people with Pain and Fear, run by Ataturk 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 7 inclusion and 1 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 29 Jul 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?
Wong-Baker Faces Pain Rating Scale (time frame: 12 week). 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 29 Jul 2022.