Family Support Weaning from Mechanical Ventilation in Cardiovascular Surgery

The Effect of Family Support on Hemodynamic Parameter, Comfort and Anxiety Level in Weaning from Mechanical Ventilation in Cardiovascular Surgery: a Randomized Controlled Study

Mechanical ventilation support is used to ensure airway clarity in patients after surgery.If patients are not informed about mechanical ventilation treatment in the pre -operation period, panic, anxiety and comfort may be experienced when they wake up from anesthesia and find them in intensive care under mechanical ventilation with various tubes and equipment. The separation from the mechanical ventilator (MV) covers the patient's mechanical support and the entire process of separation of endotrakeal tube.During the separation of the mechanical ventilator, the support of one of the patient members of the patient may increase the stress and comfort of the patient. Therefore, this research is planned

Study Overview

• Status: Completed
• Conditions: Anxiety; Patient Satisfaction; Patient Comfort
• Intervention / Treatment: Other: Family support

Detailed Description

Intensive care nurses spend a long time with patients and observe them closely. Intensive care nurses in the MV separation process; plays a special and important role. Recently, family support has been used in patient care. An increase in anxiety and comfort levels is observed in patients receiving family support. This study was planned with the aim of supporting the patient by the family member during the separation of the patient from the mechanical ventilator after cardiac surgery and to evaluate the comfort and anxiety level of the patients.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kastamonu, Turkey
    • Kastamonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Volunteering to participate in the research
• To agree to participate in the research verbally and in writing
• To be over the age of 18
• Knowing Turkish
• Not having any psychiatric disease
• No vision, hearing and perception problems
• Receiving mechanical ventilator support after cardiac surgery and being followed in the intensive care unit.

Exclusion Criteria:

• Patients who do not meet the inclusion criteria
• Other patients receiving mechanical ventilator support after surgery in the intensive care unit other than cardiac surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; When the patient comes intubated from the surgery to the cardiovascular surgery intensive care unit, when they meet the extubation criteria, the patients will be extubated by the healthcare professionals working in the intensive care unit in accordance with the service protocol.Patients in the experimental group will be provided with their relatives and support during weaning from the mechanical ventilator.	Other: Family support; Before the extubation procedure, the patient's relatives will be informed, and the patient will be allowed to enter the intensive care unit, and the patient will be able to express that he is with the patient by holding his hand and talking.; Other Names: Experimantal group
No Intervention: Control Group; Patient comes intubated from the surgery to the cardiovascular surgery intensive care unit, when they meet the extubation criteria, the patients will be extubated by the healthcare professionals working in the intensive care unit in accordance with the service protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Anxiety	State Anxiety Inventory was used to assess state anxiety. The Turkish validity and reliability of the scale were undertaken by Oner and Le Compte . The state anxiety scale composed of 20-items that shows how a person feels at a certain moment and under certain conditions. The scale score ranges from 20 to 80, with a high scores indicating high anxiety.	30 minutes before the weaning procedure.
State Anxiety	State Anxiety Inventory was used to assess state anxiety. The Turkish validity and reliability of the scale were undertaken by Oner and Le Compte. The state anxiety scale composed of 20-items that shows how a person feels at a certain moment and under certain conditions. The scale score ranges from 20 to 80, with a high scores indicating high anxiety.	after 30 minutes the weaning procedure.
Perianesthesia Comfort	This scale was developed by Kolcaba in 2003, and its Turkish validity and reliability were made by Üstündağ and Eti Aslan in 2010. It is used to evaluate the situation of reaching the expected increase in comfort by determining the comfort requirements. The scale consists of 24 items that question the self-concept and feelings of the individual reflecting the general thought process before and after the surgical intervention. The scale score ranges from 24 to 144, with a high scores indicating high comfort.	on the 1st day after surgery
Patient's systolic blood pressure (mmHg)	before weaning 1	10 minutes before weaning
Diastolic blood pressures (mmHg)	before weaning 2	10 minutes before weaning
Heart rate (per minute)	before weaning 3	10 miniutes before weaning procedure
Oxygen saturation (SpO2)	before weaning 4	10 miniutes before weaning procedure
Patient's systolic blood pressure (mmHg) - after weaning 1	Patient's systolic blood pressure (mmHg)	10 miniutes after weaning procedure
Diastolic blood pressures (mmHg) after weaning 2	Diastolic blood pressures (mmHg)	10 miniutes after weaning procedure
Heart rate (per minute) - after weaning 3	Heart rate (per minute)	10 miniutes after weaning procedure
Oxygen saturation (SpO2) - after weaning 4	Oxygen saturation (SpO2)	10 miniutes after weaning procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Visual Analog Scale	A 10-centimeter vertical VAS was used to assess the satisfaction assessment by patients after weaning procedure. The scale score ranges from 0 to 10, with a high scores indicating high satisfaction.	10 minutes after weaning procedure

Collaborators and Investigators

• Sponsor: Kastamonu University
• Investigators: Principal Investigator: Selda Karaveli Cakir, Kastamonu Universty

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2023
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 20, 2024

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Patient satisfaction; Anxiety; Weaning; Cardiac surgery; Family support
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022-KAEK-146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No