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Completed

NCT Number: NCT05820789

Family Support Weaning from Mechanical Ventilation in Cardiovascular Surgery

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

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Key information

Conditions

Patient Comfort Anxiety Anxiety Disorders Behavior Health Behavior Mental Disorders Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kastamonu University

Kastamonu, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family support

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Patient's systolic blood pressure (mmHg)

    Time frame: 10 minutes before weaning

    before weaning 1

  5. Diastolic blood pressures (mmHg)

    Time frame: 10 minutes before weaning

    before weaning 2

  6. Heart rate (per minute)

    Time frame: 10 miniutes before weaning procedure

    before weaning 3

  7. Oxygen saturation (SpO2)

    Time frame: 10 miniutes before weaning procedure

    before weaning 4

  8. Patient's systolic blood pressure (mmHg) - after weaning 1

    Time frame: 10 miniutes after weaning procedure

    Patient's systolic blood pressure (mmHg)

  9. Diastolic blood pressures (mmHg) after weaning 2

    Time frame: 10 miniutes after weaning procedure

    Diastolic blood pressures (mmHg)

  10. Heart rate (per minute) - after weaning 3

    Time frame: 10 miniutes after weaning procedure

    Heart rate (per minute)

  11. Oxygen saturation (SpO2) - after weaning 4

    Time frame: 10 miniutes after weaning procedure

    Oxygen saturation (SpO2)

Secondary outcomes

  1. The Visual Analog Scale

    Time frame: 10 minutes after weaning procedure

    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.

Sponsors and collaborators

Lead sponsor

Kastamonu University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 20, 2023
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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