Family Support Weaning From Mechanical Ventilation in Cardiovascular Surgery

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05820789
• Other study ID #: 2022-KAEK-146
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: April 2023
• Source: Kastamonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 20, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Patient Comfort
• Patient Satisfaction

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kastamonu University	Kastamonu

Sponsors (1)

Lead Sponsor	Collaborator
Kastamonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Perianesthesia Comfort	This scale was developed by Kolcaba in 2003, and its Turkish validity and reliability were made by Üstündag 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
Primary	Patient's systolic blood pressure (mmHg)	before weaning 1	10 minutes before weaning
Primary	Diastolic blood pressures (mmHg)	before weaning 2	10 minutes before weaning
Primary	Heart rate (per minute)	before weaning 3	10 miniutes before weaning procedure
Primary	Oxygen saturation (SpO2)	before weaning 4	10 miniutes before weaning procedure
Primary	Patient's systolic blood pressure (mmHg) - after weaning 1	Patient's systolic blood pressure (mmHg)	10 miniutes after weaning procedure
Primary	Diastolic blood pressures (mmHg) after weaning 2	Diastolic blood pressures (mmHg)	10 miniutes after weaning procedure
Primary	Heart rate (per minute) - after weaning 3	Heart rate (per minute)	10 miniutes after weaning procedure
Primary	Oxygen saturation (SpO2) - after weaning 4	Oxygen saturation (SpO2)	10 miniutes after weaning procedure
Secondary	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