Hematopoietic TransplantationNCT05391347
Effects of Orange Oil Aromatherapy on the Pain and Anxiety
A study testing Orange oil aromatherapy in people with Hematopoietic Transplantation and Bone Marrow Transplantation, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic Transplantation, Bone Marrow Transplantation
- What is being tested?
- Orange oil aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 30 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old,
- without communication problems,
- without allergy and respiratory system problems,
- who agreed to participate in the study
Who cannot join
- severe hypotension
- other allergic complications that made it difficult for patients to continue the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Orange Oil Aromatherapy on the Pain and Anxiety During Invasive Interventions in Patients With Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
Introduction: Invasive interventions such as peripheral intravenous cannula and port needle placement, and blood collection are often required for both inpatient and outpatient follow-up patients with hematological malignancies and hematopoietic stem cell transplantation patients. This long and difficult treatment process causes anxiety and emotional disorders in most patients. Although invasive initiatives in the treatment and monitoring process are widely implemented, they lead to pain, anxiety and discomfort, which is often ignored. This study conducted to assess the effect of orange oil inhalation used in aromatherapy on pain and anxiety levels in invasive interventions to treat patients with hematological malignancies and hematopoietic stem cells transplantation.
Methods: 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.
- Being tested
- Orange oil aromatherapy
- Keywords
- Hematopoietic stem cell transplantation, aromatherapy, pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange oil aromatherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Other: Orange oil aromatherapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 minutes before the aromatherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 May 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic TransplantationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Collaborators
- Sinop University, Acıbadem Atunizade Hospital
- Responsible party
- Principal investigator, DİLEK YILDIRIM, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391347
- Sponsor's protocol ID
- Orange oil aromatherapy
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the researchers (i.e. upon rea-sonable request).
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Orange Oil Aromatherapy on the Pain and Anxiety During Invasive Interventions in Patients With Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05391347
- Acronym / sponsor ID
- Orange oil aromatherapy
- Keywords
- Hematopoietic stem cell transplantation, aromatherapy, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Collaborators
- Sinop University, Acıbadem Atunizade Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 25 May 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.
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.
Detailed description
Introduction: Invasive interventions such as peripheral intravenous cannula and port needle placement, and blood collection are often required for both inpatient and outpatient follow-up patients with hematological malignancies and hematopoietic stem cell transplantation patients. This long and difficult treatment process causes anxiety and emotional disorders in most patients. Although invasive initiatives in the treatment and monitoring process are widely implemented, they lead to pain, anxiety and discomfort, which is often ignored. This study conducted to assess the effect of orange oil inhalation used in aromatherapy on pain and anxiety levels in invasive interventions to treat patients with hematological malignancies and hematopoietic stem cells transplantation.
Methods: 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Orange oil aromatherapy3 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 intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years old,
- without communication problems,
- without allergy and respiratory system problems,
- who agreed to participate in the study
Key exclusion criteria (2 listed)
- severe hypotension
- other allergic complications that made it difficult for patients to continue 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 |
|---|---|---|
| Orange oil aromatherapy5 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. | Other | Intervention |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 5 minutes before the aromatherapy
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
The State-Trait Anxiety Inventory (STAI)
Time frame: 5 minutes before the aromatherapy
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
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 25 May 2022.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the researchers (i.e. upon rea-sonable request).
Related trials for Hematopoietic Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
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 Orange oil aromatherapy in people with Hematopoietic Transplantation and Bone Marrow Transplantation, run by Istanbul Aydın 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 4 inclusion and 2 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 25 May 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?
Visual Analog Scale (VAS) (time frame: 5 minutes before the aromatherapy). 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 25 May 2022.