The Effect of Olfactory Mental Imagery and Cardiovascular Surgery

Anxiety State Clinical Trial

Official title:

The Effect of Olfactory Mental Imagery on Physiological Parameters, Anxiety, and Symptoms After Cardiovascular Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221436
• Other study ID #: SBUISTANBUL
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: April 2024
• Source: Istanbul Saglik Bilimleri University
• Contact: Hilal Kartal
• Phone: 5378870982
• Email: kartal_hilal[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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 breathing exercises with the olfactory mental imagery technique.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Symptoms and Signs
• Vital Signs

Intervention

Behavioral:
• Mental Imagery
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 visualize the smell by looking at the picture cards, so they will be expected to make their breathing exercises more effective. Vagus breathing technique will be combined with olfactory mental imagery.

Locations

Country	Name	City	State
Turkey	Hilal KARTAL	Istanbul	Beylikdüzü

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Saglik Bilimleri University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital Signs Observation Form	In this form; body temperature value will be evaluated.	First 4 days after surgery
Primary	Vital Signs Observation Form	In this form; respiratory rate will be evaluated.	First 4 days after surgery
Primary	Vital Signs Observation Form	In this form; pulse value will be evaluated	First 4 days after surgery
Primary	Vital Signs Observation Form	In this form; blood pressure value will be evaluated.	First 4 days after surgery
Primary	Vital Signs Observation Form	In this form; oxygen saturation value will be evaluated.	First 4 days after surgery
Primary	Vital Signs Observation Form	In this form; cerebral oxygen saturation value will be evaluated.	First 4 days after surgery
Primary	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.	First 4 days after surgery
Secondary	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.	Seven days after discharge