NCT06933771

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

October 27, 2023

Last Update Submit

April 10, 2025

Conditions

Keywords

PAİNFEAR

Outcome Measures

Primary Outcomes (2)

  • 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".

    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

    9 MONTHS

Study Arms (2)

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.

Other: LAVENDER ESSENCE GROUP

CONTROL GROUP

SHAM COMPARATOR

no intervention was made.

Other: CONTROL GROUP

Interventions

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.

Also known as: AROMATHERAPY GROUP
LAVENDER ESSENCE 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. Routine nursıng care provıed.

CONTROL GROUP

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children between the ages of 7-14 who applied to the blood collection unit, who had no mental neurological, hearing, speech, vison disorders

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çorlu State Hospital

Merkez, Tekirdağ, 59000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: LAVENDER ESSENCE GROUP - CONTROL GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

October 27, 2023

First Posted

April 18, 2025

Study Start

December 15, 2018

Primary Completion

January 15, 2019

Study Completion

September 15, 2023

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations