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Family Support Weaning From Mechanical Ventilation in Cardiovascular Surgery

Primary Purpose

Patient Comfort, Anxiety, Patient Satisfaction

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Family support
Sponsored by
Kastamonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patient Comfort focused on measuring Weaning, Patient satisfaction, Anxiety, Family support, Cardiac surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kastamonu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Patient's systolic blood pressure (mmHg)
before weaning 1
Diastolic blood pressures (mmHg)
before weaning 2
Heart rate (per minute)
before weaning 3
Oxygen saturation (SpO2)
before weaning 4
Patient's systolic blood pressure (mmHg) - after weaning 1
Patient's systolic blood pressure (mmHg)
Diastolic blood pressures (mmHg) after weaning 2
Diastolic blood pressures (mmHg)
Heart rate (per minute) - after weaning 3
Heart rate (per minute)
Oxygen saturation (SpO2) - after weaning 4
Oxygen saturation (SpO2)

Secondary Outcome Measures

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.

Full Information

First Posted
March 14, 2023
Last Updated
October 10, 2023
Sponsor
Kastamonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05820789
Brief Title
Family Support Weaning From Mechanical Ventilation in Cardiovascular Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kastamonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Comfort, Anxiety, Patient Satisfaction
Keywords
Weaning, Patient satisfaction, Anxiety, Family support, Cardiac surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Family support
Other Intervention Name(s)
Experimantal group
Intervention Description
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.
Primary Outcome Measure Information:
Title
State Anxiety
Description
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.
Time Frame
30 minutes before the weaning procedure.
Title
State Anxiety
Description
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.
Time Frame
after 30 minutes the weaning procedure.
Title
Perianesthesia Comfort
Description
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.
Time Frame
on the 1st day after surgery
Title
Patient's systolic blood pressure (mmHg)
Description
before weaning 1
Time Frame
10 minutes before weaning
Title
Diastolic blood pressures (mmHg)
Description
before weaning 2
Time Frame
10 minutes before weaning
Title
Heart rate (per minute)
Description
before weaning 3
Time Frame
10 miniutes before weaning procedure
Title
Oxygen saturation (SpO2)
Description
before weaning 4
Time Frame
10 miniutes before weaning procedure
Title
Patient's systolic blood pressure (mmHg) - after weaning 1
Description
Patient's systolic blood pressure (mmHg)
Time Frame
10 miniutes after weaning procedure
Title
Diastolic blood pressures (mmHg) after weaning 2
Description
Diastolic blood pressures (mmHg)
Time Frame
10 miniutes after weaning procedure
Title
Heart rate (per minute) - after weaning 3
Description
Heart rate (per minute)
Time Frame
10 miniutes after weaning procedure
Title
Oxygen saturation (SpO2) - after weaning 4
Description
Oxygen saturation (SpO2)
Time Frame
10 miniutes after weaning procedure
Secondary Outcome Measure Information:
Title
The Visual Analog Scale
Description
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.
Time Frame
10 minutes after weaning procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selda Karaveli Cakir
Organizational Affiliation
Kastamonu Universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kastamonu University
City
Kastamonu
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Family Support Weaning From Mechanical Ventilation in Cardiovascular Surgery

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