NCT06221436

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

January 4, 2024

Last Update Submit

April 28, 2025

Conditions

Keywords

Vital SignsAnxiety StateCardiovascular surgerySymptomMental imagery

Outcome Measures

Primary Outcomes (7)

  • Vital Signs Observation Form

    In this form; body temperature value will be evaluated.

    First 4 days after surgery

  • Vital Signs Observation Form

    In this form; respiratory rate will be evaluated.

    First 4 days after surgery

  • Vital Signs Observation Form

    In this form; pulse value will be evaluated

    First 4 days after surgery

  • Vital Signs Observation Form

    In this form; blood pressure value will be evaluated.

    First 4 days after surgery

  • Vital Signs Observation Form

    In this form; oxygen saturation value will be evaluated.

    First 4 days after surgery

  • Vital Signs Observation Form

    In this form; cerebral oxygen saturation value will be evaluated.

    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.

    First 4 days after surgery

Secondary Outcomes (1)

  • Cardiac Surgery Symptom Inventory

    Seven days after discharge

Study Arms (2)

Mental Imagery

EXPERIMENTAL

The Mental Imaging group will receive olfactory mental imagery technique and vagus breathing therapy 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.

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.

Interventions

Mental ImageryBEHAVIORAL

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.

Mental Imagery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hilal KARTAL

Istanbul, Beylikdüzü, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersSigns and Symptoms

Condition Hierarchy (Ancestors)

Mental DisordersPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled (experimental and control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 24, 2024

Study Start

April 15, 2024

Primary Completion

January 15, 2025

Study Completion

April 15, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations