Anxiety StateNCT06221436
The Effect of Olfactory Mental Imagery and Cardiovascular Surgery
A study testing Mental Imagery in people with Anxiety State and Symptoms and Signs, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effect of olfactory mental imagery on physiological parameters, anxiety and symptoms after cardiovascular surgery. This study was planned to be conducted as a prospective randomized controlled study in the Cardiovascular Surgery service of Istanbul Mehmet Akif Ersoy Thoracic and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Symptoms and Signs, Vital Signs
- What is being tested?
- Mental Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 15 Apr 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective surgery is planned,
- There is no smell problem,
- No loss of visual and auditory functions,
- No previous hospital history,
- No serious head trauma or nasal injury,
- No known psychiatric disease or history of anxiolytic drug use,
- Olfactory, capable of mental imagery
Who cannot join
- Presence of decreased level of consciousness,
- Having drainage over 200 ml per hour,
- Ejection fraction less than 30 percent,
- People with lung disease such as atelectasis and pneumonia,
- Systolic blood pressure is below 90 mmHg,
- Patients whose pain control cannot be achieved
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Olfactory Mental Imagery on Physiological Parameters, Anxiety, and Symptoms After Cardiovascular Surgery
This study aims to examine the effect of olfactory mental imagery on physiological parameters, anxiety and symptoms after cardiovascular surgery.
This study was planned to be conducted as a prospective randomized controlled study in the Cardiovascular Surgery service of Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. The universe of the research; It will consist of patients who are hospitalized in the cardiovascular surgery service and who have undergone cardiovascular surgery. The sample will consist of a total of 90 patients hospitalized in the Cardiovascular Surgery service of the same hospital and meeting the inclusion criteria for the study.
Patient Diagnosis Form, Physiological Parameters Monitoring Form, State Anxiety Inventory and Cardiac Surgery Symptom Inventory will be used to collect data. Data will be collected on days 1, 2, 3 and 4 after surgery. In the study, patients will be divided into two groups: intervention (n = 45) and control (n = 45). The intervention group will perform olfactory mental imagery technique.
- Conditions
- Anxiety State, Symptoms and Signs, Vital Signs
- Being tested
- Mental Imagery
- Keywords
- Vital Signs, Anxiety State, Cardiovascular surgery, Symptom, Mental imagery
- Medical subject headings
- Anxiety Disorders, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental ImageryBehavioural
Olfactory mental imagery is the ability to detect an odor in the absence of any odor stimulus.
Participants will be asked to choose their 4 favorite fragrances from 20 different scents (such as rose, lavender scent) determined by the researcher and proven to have positive effects on mind-body therapy. The determined odors will be visualized by the researcher and picture cards measuring 15X12 cm (for example, a card with a rose picture for the rose smell, etc.) will be created. Participants will be asked to look at the picture card, mentally imagine the smell (olfactory imagery), and, considering that pleasant odors may trigger the deep sniffing reflex, sniff as deeply as possible, briefly hold their breath, and exhale slowly through the nose.
| Study group | Role | What they receive |
|---|---|---|
| Mental Imagery | Experimental | The Mental Imaging group will receive olfactory mental imagery technique for 1 hour in the morning and evening on the 1st, 2nd, 3rd and 4th days after surgery. In addition, the standard care (breathing exercises with Triflo, early walking, frequent position changes in bed) and treatment plan, which are the standard protocol of the Cardiovascular Surgery Service, will be continued by the clinic nurse and physician. Receives: Behavioral: Mental Imagery |
| Control | No intervention | The control group was given no intervention other than standard care (breathing exercise with Triflo, early ambulation, frequent position changes in bed) and treatment, which is the standard protocol of the Cardiovascular Surgery Service, by the clinic nurse and physician on the 1st, 2nd, 3rd and 4th days after surgery. Will not be implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Signs Observation Form
In this form; body temperature value will be evaluated.
Measured: First 4 days after surgery
Vital Signs Observation Form
In this form; respiratory rate will be evaluated.
Measured: First 4 days after surgery
Vital Signs Observation Form
In this form; pulse value will be evaluated
Measured: First 4 days after surgery
Vital Signs Observation Form
In this form; blood pressure value will be evaluated.
Measured: First 4 days after surgery
Vital Signs Observation Form
In this form; oxygen saturation value will be evaluated.
Measured: First 4 days after surgery
Vital Signs Observation Form
In this form; cerebral oxygen saturation value will be evaluated.
Measured: First 4 days after surgery
State Anxiety Inventory
State Anxiety Inventory measures how the individual expresses himself in a momentary situation. The inventory consists of 20 items in total. In this inventory, each item is on a four-point Likert-type scale consisting of '(1) not at all', '(2) a little', '(3) a lot', '(4) completely' and 1. The total score obtained from the inventory varies between 20-80. High scores from the inventory indicate high anxiety.
Measured: First 4 days after surgery
Secondary outcomes (1)
Cardiac Surgery Symptom Inventory
The inventory consists of 5 subscales: general, cardiac, trunk, lower and upper extremity symptoms. The inventory is in Likert type and is evaluated between 0-4 as "Not at all", "Very little", "Moderate", "A lot", "Quite a lot". The score range to be taken from the inventory varies between 0-140. As scores increase, symptom severity also increases.
Measured: Seven days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start15 Apr 2024
- Primary completion15 Jan 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled (experimental and control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal KARTAL, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221436
- Sponsor's protocol ID
- SBUISTANBUL
- Status last verified
- Nov 2026
- First submitted
- 4 Jan 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Olfactory Mental Imagery on Physiological Parameters, Anxiety, and Symptoms After Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT06221436
- Acronym / sponsor ID
- SBUISTANBUL
- Conditions
- Anxiety State, Symptoms and Signs, Vital Signs
- Keywords
- Vital Signs, Anxiety State, Cardiovascular surgery, Symptom, Mental imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 24 Jan 2024 (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 study aims to examine the effect of olfactory mental imagery on physiological parameters, anxiety and symptoms after cardiovascular surgery.
This study was planned to be conducted as a prospective randomized controlled study in the Cardiovascular Surgery service of Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. The universe of the research; It will consist of patients who are hospitalized in the cardiovascular surgery service and who have undergone cardiovascular surgery. The sample will consist of a total of 90 patients hospitalized in the Cardiovascular Surgery service of the same hospital and meeting the inclusion criteria for the study.
Patient Diagnosis Form, Physiological Parameters Monitoring Form, State Anxiety Inventory and Cardiac Surgery Symptom Inventory will be used to collect data. Data will be collected on days 1, 2, 3 and 4 after surgery. In the study, patients will be divided into two groups: intervention (n = 45) and control (n = 45). The intervention group will perform olfactory mental imagery technique.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled (experimental and control group)
| Arm | Type | Receives |
|---|---|---|
| Mental Imagery | Experimental | Behavioral: Mental ImageryThe Mental Imaging group will receive olfactory mental imagery technique for 1 hour in the morning and evening on the 1st, 2nd, 3rd and 4th days after surgery. In addition, the standard care (breathing exercises with Triflo, early walking, frequent position changes in bed) and treatment plan, which are the standard protocol of the Cardiovascular Surgery Service, will be continued by the clinic nurse and physician. |
| Control | No intervention | –The control group was given no intervention other than standard care (breathing exercise with Triflo, early ambulation, frequent position changes in bed) and treatment, which is the standard protocol of the Cardiovascular Surgery Service, by the clinic nurse and physician on the 1st, 2nd, 3rd and 4th days after surgery. Will not be implemented. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Elective surgery is planned,
- There is no smell problem,
- No loss of visual and auditory functions,
- No previous hospital history,
- No serious head trauma or nasal injury,
Key exclusion criteria (6 listed)
- Presence of decreased level of consciousness,
- Having drainage over 200 ml per hour,
- Ejection fraction less than 30 percent,
- People with lung disease such as atelectasis and pneumonia,
- Systolic blood pressure is below 90 mmHg,
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 |
|---|---|---|
| Mental ImageryOlfactory mental imagery is the ability to detect an odor in the absence of any odor stimulus. Participants will be asked to choose their 4 favorite fragrances from 20 different scents (such as rose, lavender scent) determined by the researcher and proven to have positive effects on mind-body therapy. The determined odors will be visualized by the researcher and picture cards measuring 15X12 cm (for example, a card with a rose picture for the rose smell, etc.) will be created. Participants will be asked to look at the picture card, mentally imagine the smell (olfactory imagery), and, considering that pleasant odors may trigger the deep sniffing reflex, sniff as deeply as possible, briefly hold their breath, and exhale slowly through the nose. | Behavioural | Mental Imagery |
Primary outcome
Vital Signs Observation Form
Time frame: First 4 days after surgery
In this form; body temperature value will be evaluated.
Vital Signs Observation Form
Time frame: First 4 days after surgery
In this form; respiratory rate will be evaluated.
Vital Signs Observation Form
Time frame: First 4 days after surgery
In this form; pulse value will be evaluated
Vital Signs Observation Form
Time frame: First 4 days after surgery
In this form; blood pressure value will be evaluated.
Vital Signs Observation Form
Time frame: First 4 days after surgery
In this form; oxygen saturation value will be evaluated.
Vital Signs Observation Form
Time frame: First 4 days after surgery
In this form; cerebral oxygen saturation value will be evaluated.
State Anxiety Inventory
Time frame: First 4 days after surgery
State Anxiety Inventory measures how the individual expresses himself in a momentary situation. The inventory consists of 20 items in total. In this inventory, each item is on a four-point Likert-type scale consisting of '(1) not at all', '(2) a little', '(3) a lot', '(4) completely' and 1. The total score obtained from the inventory varies between 20-80. High scores from the inventory indicate high anxiety.
1 secondary outcome
Cardiac Surgery Symptom Inventory
Time frame: Seven days after discharge
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 6 Nov 2026.
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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.
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 Mental Imagery in people with Anxiety State and Symptoms and Signs, run by Istanbul Saglik Bilimleri 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 7 inclusion and 6 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 6 Nov 2026. 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?
Vital Signs Observation Form (time frame: First 4 days after surgery). The study lists 7 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 6 Nov 2026.