- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06933771
Children's Blood Draws: Lavender Study
The Effectiveness of Lavender Essence in Reducing Pain and Fear in Children During Blood Draws; A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tekirdağ
-
Merkez, Tekirdağ, Turkey, 59000
- Çorlu State Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
children between the ages of 7-14 who applied to the blood collection unit, who had no mental neurological, hearing, speech, vison disorders
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: LAVENDER ESSENCE GROUP
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.
|
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.
Other Names:
|
|
Sham Comparator: CONTROL GROUP
no intervention was made.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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". |
9 MONTHS
|
|
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
|
9 MONTHS
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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