PainPhase 4NCT02592044
Effect of Aromatherapy on Venopuncture Pain and Anxiety
A Phase 4 study testing peripheral venous cannulation and Aromatherapy with lavender essential oil in people with Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The effect of aromatherapy with lavender essential oil on pain and anxiety during venipuncture will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- peripheral venous cannulation and Aromatherapy with lavender essential oil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2015to Mar 2016
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be scheduled for elective surgery
- be accepted to inhale lavender
Who cannot join
- age <18 years >65 years
- preoperative pain or consumption of analgesic medication
- anxiety disorders or consumption of anxiolytic medications (i.e. SSRI, benzodiazepine)
- pregnancy or breastfeeding
- asthma, chronic obstructive pulmonary disease
- poor sense of smell
- allergy to the lavender essential oil
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Medical School
Tokat Province, 60100
About this study
Official title: Evaluation of the Effect of Aromatherapy With Lavender Essential Oil on Pain and Anxiety During Peripheral Venous Cannulation
The effect of aromatherapy with lavender essential oil on pain and anxiety during venipuncture will be evaluated.
Read the detailed description
The anxiety and pain during venipuncture may be cause to the avoidance of the medical therapy in patient as well as adult. Aromatherapy with lavender was shown that beneficial effects on chronic pain and anxiety. It's effect on acute pain and anxiety is not exactly known. In this study, the aromatherapy with the lavender will be compared with placebo to evaluate the analgesic and anxiolytic effect during peripheral venous cannulation before surgery.
- Conditions
- Pain
- Being tested
- peripheral venous cannulation, Aromatherapy with lavender essential oil, Placebo
- Keywords
- pain, anxiety, Catheterization, Peripheral
- 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.
peripheral venous cannulationProcedure or surgery
Also called cannulation
The 18 gauge venous cannula will be inserted in a peripheral vein on the back of right hand of the patient.
Aromatherapy with lavender essential oilProcedure or surgery
Also called lavender
The two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.
PlaceboProcedure or surgery
The two drops of water will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy with lavender essential oil | Experimental | The 2 drops of lavender essential oil will put on 5x5 cm gauze and the patient will inhale it for 5 minutes and during peripheral venous cannulation. Receives: Procedure: peripheral venous cannulation; Procedure: Aromatherapy with lavender essential oil |
| Placebo | Placebo comparator | The 2 drops water will put on 5x5 cm gauze ant the patient will inhale it for 5 minutes and during peripheral venous cannulation. Receives: Procedure: peripheral venous cannulation; Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
The pain of the patients during cannulation will be measured with Visual Analog Scale from 0 to 10.
Measured: Within the first 5 minutes after the peripheral venous cannula insertion process
Secondary outcomes (2)
Anxiety Level
The anxiety of the patient during cannulation will be measured with Visual Analog Scale from 0 to 10.
Measured: Within the first 5 minutes after the peripheral venous cannula insertion process
Patient Satisfaction
The patients' satisfaction will be measured with 5-point likert scale with 0 to 4.
Measured: Within the first 15 minutes after the peripheral venous cannula insertion process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
- Investigators
- Tugba Karaman, MD, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592044
- Sponsor's protocol ID
- Venpuncture pain
- Status last verified
- Mar 2016
- First submitted
- 27 Oct 2015
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Aromatherapy With Lavender Essential Oil on Pain and Anxiety During Peripheral Venous Cannulation
- ClinicalTrials.gov ID
- NCT02592044
- Acronym / sponsor ID
- Venpuncture pain
- Conditions
- Pain
- Keywords
- pain, anxiety, Catheterization, Peripheral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Oct 2015 (estimated)
- 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 effect of aromatherapy with lavender essential oil on pain and anxiety during venipuncture will be evaluated.
Detailed description
The anxiety and pain during venipuncture may be cause to the avoidance of the medical therapy in patient as well as adult. Aromatherapy with lavender was shown that beneficial effects on chronic pain and anxiety. It's effect on acute pain and anxiety is not exactly known. In this study, the aromatherapy with the lavender will be compared with placebo to evaluate the analgesic and anxiolytic effect during peripheral venous cannulation before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy with lavender essential oil | Experimental | Procedure: peripheral venous cannulation, Procedure: Aromatherapy with lavender essential oilThe 2 drops of lavender essential oil will put on 5x5 cm gauze and the patient will inhale it for 5 minutes and during peripheral venous cannulation. |
| Placebo | Placebo comparator | Procedure: peripheral venous cannulation, Procedure: PlaceboThe 2 drops water will put on 5x5 cm gauze ant the patient will inhale it for 5 minutes and during peripheral venous cannulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- be scheduled for elective surgery
- be accepted to inhale lavender
Key exclusion criteria (7 listed)
- age <18 years >65 years
- preoperative pain or consumption of analgesic medication
- anxiety disorders or consumption of anxiolytic medications (i.e. SSRI, benzodiazepine)
- pregnancy or breastfeeding
- asthma, chronic obstructive pulmonary disease
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 |
|---|---|---|
| peripheral venous cannulationAlso: cannulationThe 18 gauge venous cannula will be inserted in a peripheral vein on the back of right hand of the patient. | Procedure or surgery | Aromatherapy with lavender essential oil, Placebo |
| Aromatherapy with lavender essential oilAlso: lavenderThe two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation. | Procedure or surgery | Aromatherapy with lavender essential oil |
| PlaceboThe two drops of water will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation. | Procedure or surgery | Placebo |
Primary outcome
Pain Level
Time frame: Within the first 5 minutes after the peripheral venous cannula insertion process
The pain of the patients during cannulation will be measured with Visual Analog Scale from 0 to 10.
2 secondary outcomes
Anxiety Level
Time frame: Within the first 5 minutes after the peripheral venous cannula insertion process
Patient Satisfaction
Time frame: Within the first 15 minutes after the peripheral venous cannula insertion process
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 21 Mar 2016.
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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.
Tugba Karaman, MD principal investigator
Gaziosmanpasa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing peripheral venous cannulation and Aromatherapy with lavender essential oil in people with Pain, run by Tokat Gaziosmanpasa 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 2 inclusion and 7 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 21 Mar 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Level (time frame: Within the first 5 minutes after the peripheral venous cannula insertion process). 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 21 Mar 2016.