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Clinical Trials/NCT05820789
NCT05820789CompletedNot Applicable

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

Kastamonu University1 site in 1 country40 target enrollmentStarted: April 30, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Oxygen saturation (SpO2)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Experimental Group

Experimental

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.

Intervention: Family support (Other)

Control Group

No Intervention

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 Outcomes

Oxygen saturation (SpO2)

Time Frame: 10 miniutes before weaning procedure

before weaning 4

Heart rate (per minute)

Time Frame: 10 miniutes before weaning procedure

before weaning 3

State Anxiety

Time Frame: after 30 minutes the weaning procedure.

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

Time Frame: on the 1st day after surgery

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) - after weaning 1

Time Frame: 10 miniutes after weaning procedure

Patient's systolic blood pressure (mmHg)

Patient's systolic blood pressure (mmHg)

Time Frame: 10 minutes before weaning

before weaning 1

Diastolic blood pressures (mmHg) after weaning 2

Time Frame: 10 miniutes after weaning procedure

Diastolic blood pressures (mmHg)

Heart rate (per minute) - after weaning 3

Time Frame: 10 miniutes after weaning procedure

Heart rate (per minute)

Diastolic blood pressures (mmHg)

Time Frame: 10 minutes before weaning

before weaning 2

Oxygen saturation (SpO2) - after weaning 4

Time Frame: 10 miniutes after weaning procedure

Oxygen saturation (SpO2)

State Anxiety

Time Frame: 30 minutes before the weaning procedure.

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.

Secondary Outcomes

  • The Visual Analog Scale(10 minutes after weaning procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Selda Karaveli Çakır

Assistant professor

Kastamonu University

Study Sites (1)

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