Effects of Orange Oil Aromatherapy on the Pain and Anxiety
1 other identifier
interventional
80
1 country
1
Brief Summary
This randomized controlled experimental study was conducted prospectively with 80 patients with hematological malignancies were treated in the adult bone marrow transplant unit and adult hematology service of a private hospital between May 2021 and January 2022. Orange oil inhalation used in aromatherapy was applied to patients in the intervention group. Visual Analogue Scale and the State-Trait Anxiety Inventory used for data collection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
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
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2022
CompletedFirst Submitted
Initial submission to the registry
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedMay 25, 2022
May 1, 2022
9 months
May 18, 2022
May 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Visual Analog Scale (VAS)
Visual Analog Scale; A scale applied on a straight line by marking a millimeter horizontal or vertical line. In this line, the 0 cm dot means "No Pain", while the 10 cm dot means "very bad pain". The patient marks the pain level on the scale. The marked point is measured using a tape measure and scored. Most studies so far show that visual analogue scale (VAS) is a reliable tool to use to assess the pain level
5 minutes before the aromatherapy
The State-Trait Anxiety Inventory (STAI)
In scale; there are 20 questions in the state area. It provides a four-point Likert type measurement. Scoring varies between 20-80. Although there is not a clear cut-off point, 39-40 points are often considered as the cut-off point of inventory. High score indicates high level of anxiety
5 minutes before the aromatherapy
Study Arms (2)
Intervention
EXPERIMENTAL3 ml of orange oil were dripping onto the sponge, and the patient was told to breathe slowly at a distance of 3 cm and to smell during the process
Control
NO INTERVENTIONInterventions
5 minutes before the invasive procedure, 3 ml of orange oil were dripping onto the sponge, and the patient was told to breathe slowly at a distance of 3 cm and to smell during the process.
Eligibility Criteria
You may qualify if:
- Patients older than 18 years old,
- without communication problems,
- without allergy and respiratory system problems,
- who agreed to participate in the study
You may not qualify if:
- severe hypotension
- other allergic complications that made it difficult for patients to continue the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul Aydın Universitylead
- Sinop Universitycollaborator
- Acıbadem Atunizade Hospitalcollaborator
Study Sites (1)
Istanbul Aydin University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Prof.
Study Record Dates
First Submitted
May 18, 2022
First Posted
May 25, 2022
Study Start
May 1, 2021
Primary Completion
January 30, 2022
Study Completion
January 30, 2022
Last Updated
May 25, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
The data that support the findings of this study are available from the researchers (i.e. upon rea-sonable request).