Nursing CariesNCT06933771
Children's Blood Draws: Lavender Study
A study testing LAVENDER ESSENCE GROUP in people with Nursing Caries and Pain Management, run by Corlu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to show the effect of lavender scent used to reduce pain and fear during blood collection in children aged 7-14. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Pain Management
- What is being tested?
- LAVENDER ESSENCE GROUP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2018to 15 Sep 2023
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children between the ages of 7-14 who applied to the blood collection unit, who had no mental neurological, hearing, speech, vison disorders
Who cannot join
- who were not allergic to lavender essence, who were not diagnosed with asthma, allergies, epilepsy, dermatitis who had not taken analgesics in the last 6 hours were included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Lavender Essence in Reducing Pain and Fear in Children During Blood Draws; A Randomized Controlled Study
The aim of this study is to show the effect of lavender scent used to reduce pain and fear during blood collection in children aged 7-14.
Read the detailed description
The children in the experimental group were given lavender scent before the blood collection procedure. No additional intervention was made to the children in the control group. The pain and fear scores of both groups were evaluated.
- Conditions
- Nursing Caries, Pain Management
- Being tested
- LAVENDER ESSENCE GROUP, CONTROL GROUP
- Keywords
- PAİN, FEAR
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAVENDER ESSENCE GROUPOther
Also called AROMATHERAPY GROUP
Parents stood on the left side, easily visible to the child. The sole routine method used to reduce pain in the blood collection unit of the hospital in which the study was conducted is the presence of parents during the procedure. In this study, all children in both intervention and control groups were accompanied by their parents. Afterwards, the researcher explained to the children in the intervention group and their parents how to apply the lavender essence and what kind of a plant lavender is, and showed the bottle of essential oil to be used during the procedure. A 5x5 cm sponge with 2 drops of almond oil that contains 1% lavender essence was located on the shoulder of the children to smell for 5 minutes.
CONTROL GROUPOther
Parents stood on the left side, easily visible to the child. The sole routine method used to reduce pain in the blood collection unit of the hospital in which the study was conducted is the presence of parents during the procedure. In this study, all children in both intervention and control groups were accompanied by their parents. Routine nursıng care provıed.
| Study group | Role | What they receive |
|---|---|---|
| LAVENDER ESSENCE GROUP | Active comparator | the researcher explained to the children in the intervention group and their parents how to apply the lavender essence and what kind of a plant lavender is, and showed the bottle of essential oil to be used during the procedure. A 5x5 cm sponge with 2 drops of almond oil that contains 1% lavender essence was located on the shoulder of the children to smell for 5 minutes. Receives: Other: LAVENDER ESSENCE GROUP |
| CONTROL GROUP | Sham comparator | no intervention was made. Receives: Other: CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Medical Fear Scale (CMFS)
It is a 3-point Likert type scale that includes 29 items expressing the medical fears of children. For each item, the child is asked to choose one of the following responses: "not all afraid" (1), "a little afraid" (2), "very afraid" (3). The scale has 4 subscale dimensions which are procedural fears, environmental fears, intrapersonal fears and interpersonal fears. The total score that can be obtained on the scale ranges from 29 as the lowest to 87 as the highest .
Children who score between 0-29 points are considered "not afraid" while the children who score between 29-58 points are considered "a little afraid", and children who score between 58-87 points are considered "very afraid".
Measured: 9 MONTHS
Wong-Baker FACES Pain Rating Scale (WBFPRS)
On the scale, there are 6 facial expressions that are presented on a horizontal plane and scored from 0 to 10. The happy facial expression on the far left represents a score of 0, meaning "doesn't hurt at all" and the crying facial expression on the far right represents a score of 10, meaning "hurts as much as you can imagine
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start15 Dec 2018
- Primary completion15 Jan 2019
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies 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
- LAVENDER ESSENCE GROUP - CONTROL GROUP
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corlu State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gülsev Kutman, Corlu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933771
- Sponsor's protocol ID
- Çorlu State Hospital
- Status last verified
- Apr 2025
- First submitted
- 27 Oct 2023
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Lavender Essence in Reducing Pain and Fear in Children During Blood Draws; A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06933771
- Acronym / sponsor ID
- Çorlu State Hospital
- Conditions
- Nursing Caries, Pain Management
- Keywords
- PAİN, FEAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Corlu State HospitalOther government
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 18 Apr 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.
The aim of this study is to show the effect of lavender scent used to reduce pain and fear during blood collection in children aged 7-14.
Detailed description
The children in the experimental group were given lavender scent before the blood collection procedure. No additional intervention was made to the children in the control group. The pain and fear scores of both groups were evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- LAVENDER ESSENCE GROUP - CONTROL GROUP
| Arm | Type | Receives |
|---|---|---|
| LAVENDER ESSENCE GROUP | Active comparator | Other: LAVENDER ESSENCE GROUPthe researcher explained to the children in the intervention group and their parents how to apply the lavender essence and what kind of a plant lavender is, and showed the bottle of essential oil to be used during the procedure. A 5x5 cm sponge with 2 drops of almond oil that contains 1% lavender essence was located on the shoulder of the children to smell for 5 minutes. |
| CONTROL GROUP | Sham comparator | Other: CONTROL GROUPno intervention was made. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children between the ages of 7-14 who applied to the blood collection unit, who had no mental neurological, hearing, speech, vison disorders
Key exclusion criteria (1 listed)
- who were not allergic to lavender essence, who were not diagnosed with asthma, allergies, epilepsy, dermatitis who had not taken analgesics in the last 6 hours were included in the study
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 |
|---|---|---|
| LAVENDER ESSENCE GROUPAlso: AROMATHERAPY GROUPParents stood on the left side, easily visible to the child. The sole routine method used to reduce pain in the blood collection unit of the hospital in which the study was conducted is the presence of parents during the procedure. In this study, all children in both intervention and control groups were accompanied by their parents. Afterwards, the researcher explained to the children in the intervention group and their parents how to apply the lavender essence and what kind of a plant lavender is, and showed the bottle of essential oil to be used during the procedure. A 5x5 cm sponge with 2 drops of almond oil that contains 1% lavender essence was located on the shoulder of the children to smell for 5 minutes. | Other | LAVENDER ESSENCE GROUP |
| CONTROL GROUPParents stood on the left side, easily visible to the child. The sole routine method used to reduce pain in the blood collection unit of the hospital in which the study was conducted is the presence of parents during the procedure. In this study, all children in both intervention and control groups were accompanied by their parents. Routine nursıng care provıed. | Other | CONTROL GROUP |
Primary outcome
Child Medical Fear Scale (CMFS)
Time frame: 9 MONTHS
It is a 3-point Likert type scale that includes 29 items expressing the medical fears of children. For each item, the child is asked to choose one of the following responses: "not all afraid" (1), "a little afraid" (2), "very afraid" (3). The scale has 4 subscale dimensions which are procedural fears, environmental fears, intrapersonal fears and interpersonal fears. The total score that can be obtained on the scale ranges from 29 as the lowest to 87 as the highest . Children who score between 0-29 points are considered "not afraid" while the children who score between 29-58 points are considered "a little afraid", and children who score between 58-87 points are considered "very afraid".
Wong-Baker FACES Pain Rating Scale (WBFPRS)
Time frame: 9 MONTHS
On the scale, there are 6 facial expressions that are presented on a horizontal plane and scored from 0 to 10. The happy facial expression on the far left represents a score of 0, meaning "doesn't hurt at all" and the crying facial expression on the far right represents a score of 10, meaning "hurts as much as you can imagine
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 18 Apr 2025.
- 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 LAVENDER ESSENCE GROUP in people with Nursing Caries and Pain Management, run by Corlu State Hospital 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 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 18 Apr 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. Some participants in this study may receive a placebo. 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?
Child Medical Fear Scale (CMFS) (time frame: 9 MONTHS). 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 18 Apr 2025.