Coronary Artery Bypass Graft SurgeryNCT05377983
The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft
A study testing Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes in people with Coronary Artery Bypass Graft Surgery, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Cardiovascular diseases are among the important health problems due to their increasing frequency and extensity in developed and developing countries. The most common method of treating cardiovascular diseases is Coronary Artery Bypass Graft (CABG) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery
- What is being tested?
- Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2021to 24 Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria for the study were determined as follows:
- 18 years of age or older,
- undergoing elective CABG surgery,
- negative lavender oil allergy test,
- being conscious and oriented to place, person, and time,
- not having any disability that would make communication difficult,
- being able to communicate in Turkish, and
- giving informed written consent to participate in the study.
Who cannot join
- The exclusion criteria for the study were determined as follows:
- diagnosed with a sleep disorder or using any pharmacological and/or herbal medicine for insomnia,
- being allergic to lavender, cosmetics, or perfume,
- having a history of dermatitis,
- sinusitis,
- upper respiratory tract infection,
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- liver and kidney dysfunction,
- asthma, and
- chronic obstructive pulmonary disease,
- not having regulated blood pressure,
- having arrhythmia,
- using patient-controlled analgesia after surgery,
- not being able to communicate in Turkish.
- The remaining exclusion criteria were determined as follows:
- a positive lavender oil allergy test,
- development of lavender allergy during the study,
- voluntarily deciding to leave the study, and
- not complying with the study process and conditions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yesim Dikmen Aydin
Maltepe, Istanbul, 34854
YESIM DIKMEN AYDIN, 05426238394, yesimdikmen@hotmail.com
About this study
Official title: The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft: a Randomized Controlled Trial Protocol
Cardiovascular diseases are among the important health problems due to their increasing frequency and extensity in developed and developing countries. The most common method of treating cardiovascular diseases is Coronary Artery Bypass Graft (CABG) surgery. Common pain, sleep problems, and anxiety after CABG surgery can cause delay in postoperative recovery both physically and mentally. The study was planned to evaluate the effect of lavender oil inhalation on pain, anxiety level and sleep quality after CABG surgery.
Read the detailed description
The study is a non-drug clinical, randomized controlled study, and will be conducted in the Cardiovascular Surgery Clinic of Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi associated to Istanbul Provincial Directorate of Health between December 2020 and December 2021. Criteria to be included in the study were determined as patients who are aged 18 years and over, underwent planned (elective) CABG surgery, whose lavender oil allergy test is negative, who is conscious with place, person and time orientation, who do not have any disability that would make communication difficult, can be communicated in Turkish, were informed to participate in the study and gave written consent. Criteria to be excluded from the study were determined as patients who are allergic to lavender, cosmetics and perfume, have a history of dermatitis, are diagnosed with sleep disorders and use any pharmacological and herbal medicines for these disorders, have sinusitis, upper respiratory tract infection, liver and kidney dysfunction, asthma and Chronic Obstructive Pulmonary Disease (COPD), whose blood pressure is not regulated, have arrhythmia, use controlled analgesia after surgery and cannot be communicated in Turkish. Criteria to be eliminated from the study were determined as patients, who have positive lavender oil allergy test, develop lavender allergy during application, want to leave the study voluntarily, and do not comply with the working process and conditions.
- Conditions
- Coronary Artery Bypass Graft Surgery
- Being tested
- Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes
- Keywords
- lavender oil, pain, anxiety, sleep
- 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.
Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutesOther
During the hospitalization period after CABG surgery, 2% lavender oil (Lavandula angustifolia) inhalation will be applied to the intervention group three times a day.
| Study group | Role | What they receive |
|---|---|---|
| the intervention group | Experimental | Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes. Pain intensity and vital signs will be evaluated and recorded before each application and in the first five minutes after the application. Receives: Other: Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes |
| the control group | No intervention | The control group will only receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity, will be evaluated by NRS 3 times a day in the intervention and control group upon admission from the intensive care unit to the clinic, before and 30 minutes and four hours after each analgesic administration.In addition to this application, pain intensity will be evaluated with NRS before and five minutes after lavender oil inhalation in intervention group patients.
Measured: Up to five days
Anxiety level
Anxitey level will be evaluated using the STAI-I at four hours after analgesic administration in the intervention group and at five minutes after lavender oil inhalation.
Measured: Up to five days
Sleep quality
Sleep quality will also be evaluated using RCSQ every morning during.
Measured: Up to five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start17 Jun 2021
- Primary completion30 May 2022 (estimated)
- Study completion24 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YEŞİM DİKMEN AYDIN, Principal investigator, Marmara University Faculty of Health Sciences,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377983
- Sponsor's protocol ID
- MU-YDIKMEN-001
- Status last verified
- May 2022
- First submitted
- 18 Apr 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft: a Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT05377983
- Acronym / sponsor ID
- MU-YDIKMEN-001
- Conditions
- Coronary Artery Bypass Graft Surgery
- Keywords
- lavender oil, pain, anxiety, sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 24 Aug 2023 (estimated)
- First posted
- 17 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.
Cardiovascular diseases are among the important health problems due to their increasing frequency and extensity in developed and developing countries. The most common method of treating cardiovascular diseases is Coronary Artery Bypass Graft (CABG) surgery. Common pain, sleep problems, and anxiety after CABG surgery can cause delay in postoperative recovery both physically and mentally. The study was planned to evaluate the effect of lavender oil inhalation on pain, anxiety level and sleep quality after CABG surgery.
Detailed description
The study is a non-drug clinical, randomized controlled study, and will be conducted in the Cardiovascular Surgery Clinic of Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi associated to Istanbul Provincial Directorate of Health between December 2020 and December 2021. Criteria to be included in the study were determined as patients who are aged 18 years and over, underwent planned (elective) CABG surgery, whose lavender oil allergy test is negative, who is conscious with place, person and time orientation, who do not have any disability that would make communication difficult, can be communicated in Turkish, were informed to participate in the study and gave written consent. Criteria to be excluded from the study were determined as patients who are allergic to lavender, cosmetics and perfume, have a history of dermatitis, are diagnosed with sleep disorders and use any pharmacological and herbal medicines for these disorders, have sinusitis, upper respiratory tract infection, liver and kidney dysfunction, asthma and Chronic Obstructive Pulmonary Disease (COPD), whose blood pressure is not regulated, have arrhythmia, use controlled analgesia after surgery and cannot be communicated in Turkish. Criteria to be eliminated from the study were determined as patients, who have positive lavender oil allergy test, develop lavender allergy during application, want to leave the study voluntarily, and do not comply with the working process and conditions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes.
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Experimental | Other: Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutesLavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes. Pain intensity and vital signs will be evaluated and recorded before each application and in the first five minutes after the application. |
| the control group | No intervention | –The control group will only receive routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The inclusion criteria for the study were determined as follows:
Key exclusion criteria (18 listed)
- The exclusion criteria for the study were determined as follows:
- The remaining exclusion criteria were determined as follows:
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 inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutesDuring the hospitalization period after CABG surgery, 2% lavender oil (Lavandula angustifolia) inhalation will be applied to the intervention group three times a day. | Other | the intervention group |
Primary outcome
Pain intensity
Time frame: Up to five days
Pain intensity, will be evaluated by NRS 3 times a day in the intervention and control group upon admission from the intensive care unit to the clinic, before and 30 minutes and four hours after each analgesic administration.In addition to this application, pain intensity will be evaluated with NRS before and five minutes after lavender oil inhalation in intervention group patients.
Anxiety level
Time frame: Up to five days
Anxitey level will be evaluated using the STAI-I at four hours after analgesic administration in the intervention group and at five minutes after lavender oil inhalation.
Sleep quality
Time frame: Up to five days
Sleep quality will also be evaluated using RCSQ every morning during.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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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.
YEŞİM DİKMEN AYDIN principal investigator
Marmara University Faculty of Health Sciences,
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 inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes in people with Coronary Artery Bypass Graft Surgery, run by Marmara 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 8 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 17 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YEŞIM DIKMEN AYDIN (+905426238394, yesimdikmen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Up to five days). The study lists 3 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 17 May 2022.