Patient ComfortNCT05820789
Family Support Weaning from Mechanical Ventilation in Cardiovascular Surgery
A study testing Family support in people with Patient Comfort and Anxiety, run by Kastamonu University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Comfort, Anxiety, Patient Satisfaction
- What is being tested?
- Family support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Patient Comfort, Anxiety, Patient Satisfaction
- Being tested
- Family support
- Keywords
- Weaning, Patient satisfaction, Anxiety, Family support, Cardiac surgery
- Medical subject headings
- Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family supportOther
Also called Experimantal group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Family support |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: on the 1st day after surgery
Patient's systolic blood pressure (mmHg)
before weaning 1
Measured: 10 minutes before weaning
Diastolic blood pressures (mmHg)
before weaning 2
Measured: 10 minutes before weaning
Heart rate (per minute)
before weaning 3
Measured: 10 miniutes before weaning procedure
Oxygen saturation (SpO2)
before weaning 4
Measured: 10 miniutes before weaning procedure
Patient's systolic blood pressure (mmHg) - after weaning 1
Patient's systolic blood pressure (mmHg)
Measured: 10 miniutes after weaning procedure
Diastolic blood pressures (mmHg) after weaning 2
Diastolic blood pressures (mmHg)
Measured: 10 miniutes after weaning procedure
Heart rate (per minute) - after weaning 3
Heart rate (per minute)
Measured: 10 miniutes after weaning procedure
Oxygen saturation (SpO2) - after weaning 4
Oxygen saturation (SpO2)
Measured: 10 miniutes after weaning procedure
Secondary outcomes (1)
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.
Measured: 10 minutes after weaning procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start30 Apr 2023
- Primary completion30 Apr 2023
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Karaveli Çakır, Kastamonu University
- Investigators
- Selda Karaveli Cakir, Principal investigator, Kastamonu Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820789
- Sponsor's protocol ID
- 2022-KAEK-146
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05820789
- Acronym / sponsor ID
- 2022-KAEK-146
- Conditions
- Patient Comfort, Anxiety, Patient Satisfaction
- Keywords
- Weaning, Patient satisfaction, Anxiety, Family support, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Family supportWhen 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family supportAlso: Experimantal groupBefore 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 | Experimental Group |
Primary outcome
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.
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)
Time frame: 10 minutes before weaning
before weaning 1
Diastolic blood pressures (mmHg)
Time frame: 10 minutes before weaning
before weaning 2
Heart rate (per minute)
Time frame: 10 miniutes before weaning procedure
before weaning 3
Oxygen saturation (SpO2)
Time frame: 10 miniutes before weaning procedure
before weaning 4
Patient's systolic blood pressure (mmHg) - after weaning 1
Time frame: 10 miniutes after weaning procedure
Patient's systolic blood pressure (mmHg)
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)
Oxygen saturation (SpO2) - after weaning 4
Time frame: 10 miniutes after weaning procedure
Oxygen saturation (SpO2)
1 secondary outcome
The Visual Analog Scale
Time frame: 10 minutes after weaning procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Karaveli Cakir principal investigator
Kastamonu Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family support in people with Patient Comfort and Anxiety, run by Kastamonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety (time frame: 30 minutes before the weaning procedure.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.