Preoperative AnxietyNCT03460145
Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia
A study testing Lavender Oil on Nasal Strip (Lx), Strip without Lavender Oil (Px) and Propofol 1 % Injectable Suspension in people with Preoperative Anxiety, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
Assessment of how Lavender oil reduces preoperative anxiety and subsequently influences requirement of induction agents for general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Lavender Oil on Nasal Strip (Lx), Strip without Lavender Oil (Px) and Propofol 1 % Injectable Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteMalaysia
- Study dates
- 27 Sep 2018to 1 Jan 2019
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Female
Who cannot join
- Patients on B-blockers and or antidepressants.
- BMI > 35kg/m2
- History of atopy
- History of alcoholism, substance abuse, smoking
- Patients with cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lavender Aromatherapy; Its Effect on Preoperative Anxiety and Propofol Requirement for Anaesthesia.
Assessment of how Lavender oil reduces preoperative anxiety and subsequently influences requirement of induction agents for general anesthesia.
Read the detailed description
This study aims to use aromatherapy (Lavender oil) to reduce Preoperative Anxiety among Female patients coming for elective surgeries under General Anesthesia.
As a consequence of that, the effect is also evaluated on how that influences the amount of intravenous sedation is required during induction for General Anesthesia.
- Conditions
- Preoperative Anxiety
- Being tested
- Lavender Oil on Nasal Strip (Lx), Strip without Lavender Oil (Px), Propofol 1 % Injectable Suspension
- Keywords
- Lavender Oil,, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender Oil on Nasal Strip (Lx)Other
Usage of Aromatherapy for Preoperative Anxiety
Strip without Lavender Oil (Px)Other
Strip without Lavender Oil (Px)
Propofol 1 % Injectable SuspensionDrug
Propofol 1% (10mg/mL)
| Study group | Role | What they receive |
|---|---|---|
| Strip with Lavender Oil (Lx) | Experimental | Application of Nasal Strip with essential oil (Lavender), 20minutes before induction.
VAS- Anxiety scores pre and post inhalation. Receives: Other: Lavender Oil on Nasal Strip (Lx); Drug: Propofol 1 % Injectable Suspension |
| Strip without Lavender Oil (Px) | Placebo comparator | Application of Nasal strip without essential oil, acting as placebo. VAS- Anxiety scores pre and post placebo. Receives: Other: Strip without Lavender Oil (Px); Drug: Propofol 1 % Injectable Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Visual Analog Scoring for Anxiety
Self reported anxiety score before and after inhalation of aromatherapy. 3 questions about preoperative anxiety are asked and scoring is done based on a 0-10cm scale (0= no anxiety, 10= agonizing anxiety). Cumulative scores for all 3 questions above 5 indicates preoperative anxiety.
Measured: 1 day
Secondary outcomes (1)
1. Amount of sedation used to achieve Loss of Consciousness
Induction for general anesthesia using Target control Infusion of Propofol 1% (10mg/mL) using the Schnider protocol, administered via a TIVA Agilia infusion pump to achieve a target plasma concentration of 4mcg/ml until loss of consciousness.
Measured: Less than 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start27 Sep 2018
- Primary completion10 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raha Abdul Rahman, MD, Principal investigator, Consultant Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460145
- Sponsor's protocol ID
- 37839
- Status last verified
- Apr 2018
- First submitted
- 24 Jan 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lavender Aromatherapy; Its Effect on Preoperative Anxiety and Propofol Requirement for Anaesthesia.
- ClinicalTrials.gov ID
- NCT03460145
- Acronym / sponsor ID
- 37839
- Conditions
- Preoperative Anxiety
- Keywords
- Lavender Oil,, Propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 9 Mar 2018 (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.
Assessment of how Lavender oil reduces preoperative anxiety and subsequently influences requirement of induction agents for general anesthesia.
Detailed description
This study aims to use aromatherapy (Lavender oil) to reduce Preoperative Anxiety among Female patients coming for elective surgeries under General Anesthesia.
As a consequence of that, the effect is also evaluated on how that influences the amount of intravenous sedation is required during induction for General Anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strip with Lavender Oil (Lx) | Experimental | Other: Lavender Oil on Nasal Strip (Lx), Drug: Propofol 1 % Injectable SuspensionApplication of Nasal Strip with essential oil (Lavender), 20minutes before induction. VAS- Anxiety scores pre and post inhalation. |
| Strip without Lavender Oil (Px) | Placebo comparator | Other: Strip without Lavender Oil (Px), Drug: Propofol 1 % Injectable SuspensionApplication of Nasal strip without essential oil, acting as placebo. VAS- Anxiety scores pre and post placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65
- Female
Key exclusion criteria (5 listed)
- Patients on B-blockers and or antidepressants.
- BMI > 35kg/m2
- History of atopy
- History of alcoholism, substance abuse, smoking
- Patients with cancer
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 |
|---|---|---|
| Lavender Oil on Nasal Strip (Lx)Usage of Aromatherapy for Preoperative Anxiety | Other | Strip with Lavender Oil (Lx) |
| Strip without Lavender Oil (Px)Strip without Lavender Oil (Px) | Other | Strip without Lavender Oil (Px) |
| Propofol 1 % Injectable SuspensionPropofol 1% (10mg/mL) | Drug | Strip with Lavender Oil (Lx), Strip without Lavender Oil (Px) |
Primary outcome
1. Visual Analog Scoring for Anxiety
Time frame: 1 day
Self reported anxiety score before and after inhalation of aromatherapy. 3 questions about preoperative anxiety are asked and scoring is done based on a 0-10cm scale (0= no anxiety, 10= agonizing anxiety). Cumulative scores for all 3 questions above 5 indicates preoperative anxiety.
1 secondary outcome
1. Amount of sedation used to achieve Loss of Consciousness
Time frame: Less than 30minutes
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 May 2019.
- Individual participant dataSharing planned: No
Related trials for Preoperative Anxiety
Recruiting
Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
Anxiety, Osteoarthritis
Not yet recruitingPhase 4
Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
Propofol Injection Pain, Postoperative Recall of Pain
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruiting
Virtual Reality to Reduce Anxiety During Thoracic Epidural Placement.
Preoperative Anxiety Score
Recruiting
Positive Affirmations and Preoperative Anxiety
Total Joint Replacement Surgery, Preoperative Anxiety
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.
Raha Abdul Rahman, MD principal investigator
Consultant Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Oil on Nasal Strip (Lx), Strip without Lavender Oil (Px) and Propofol 1 % Injectable Suspension in people with Preoperative Anxiety, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 5 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 May 2019. 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 Malaysia. 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.
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?
1. Visual Analog Scoring for Anxiety (time frame: 1 day). 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 May 2019.