Surgery (Cardiac)NCT06769945
Kolcaba's Comfort Theory on the Comfort Levels of Patients Undergoing Open Heart Valve Surgery
A study testing Nursing Care Based on Kolcaba's Comfort Theory in people with Surgery (Cardiac), run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
It is planned to determine the effect of comfort theory-based nursing care on the comfort and pain levels of patients undergoing open heart valve surgery. Does nursing care based on comfort theory reduce the comfort of patients undergoing open heart valve surgery? Does nursing care based on comfort theory reduce the… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery (Cardiac)
- What is being tested?
- Nursing Care Based on Kolcaba's Comfort Theory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2024to 1 Jul 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study,
- Being 18 years of age or older,
- Being open to communication,
- Not having any obstacle in terms of consciousness and sensory organs,
- Being in the cardiovascular surgery service clinic
Who cannot join
- Hearing and/or visual loss
- Leaving the study voluntarily
- Patients transferred from the ward environment back to the intensive care environment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Comfort Levels of Patients Undergoing Open Heart Valve Surgery
It is planned to determine the effect of comfort theory-based nursing care on the comfort and pain levels of patients undergoing open heart valve surgery.
- Does nursing care based on comfort theory reduce the comfort of patients undergoing open heart valve surgery?
- Does nursing care based on comfort theory reduce the pain level of patients undergoing open heart valve surgery?
- Does nursing care based on comfort theory increase the comfort level of patients undergoing open heart valve surgery?
- Does nursing care based on comfort theory increase the pain level of patients undergoing open heart valve surgery?
Read the detailed description
Comfort is defined as "an expected result with a complex structure within the physical, psychological, social and environmental integrity of helping the individual with his/her needs, providing peace of mind and being able to overcome problems." In his theory, Kolcaba defined comfort as "an expected result with a complex structure within the physical, psychospiritual, social and environmental integrity of helping the individual with his needs, providing peace of mind and overcoming problems. This situation affects recovery and discharge times. Studies indicate that comfort is one of the most important factors affecting the speed of recovery. The sample size of the study was determined using power analysis. As a result of the Power analysis (G*Power 3.1.9.4); when the effect size was taken as Cohen's d: 0.95, the number of samples determined for a confidence interval of 95%, a power of 95%, and a margin of error of 0.05 was determined as a total of 50 patients, with a minimum of 25 patients for each group (Experimental and Control). Considering the block randomization distributions, the study was completed with 56 patients.
- Conditions
- Surgery (Cardiac)
- Being tested
- Nursing Care Based on Kolcaba's Comfort Theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Care Based on Kolcaba's Comfort TheoryBehavioural
Also called In practice, patient education, pain management, emotional support, appropriate environmental arrangements and individualised care come to the fore. Studies show that with this approach, patients' phy
In practice, patient education, pain management, emotional support, appropriate environmental arrangements and individualised care come to the fore. Studies show that with this approach, patients' physical comfort increases, anxiety levels decrease and overall satisfaction improves. It is stated that nursing care based on Kolcaba's theory offers an effective model to improve the quality of life of postoperative patients.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Patients in the experimental group will receive nursing care based on Kolcaba's Comfort Theory during their stay in the cardiovascular surgery service. After determining the comfort-oriented care needs of the patients, the General Comfort Scale will be used and individualised nursing care plans will be created in line with these needs. According to Kolcaba, standard comfort interventions and comfort interventions provided by coaching will be applied. Receives: Behavioral: Nursing Care Based on Kolcaba's Comfort Theory |
| Control | No intervention | Control group patients will receive routine nursing care in the ward environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
comfort
General Comfort Scale:The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. Low comfort represents one point, and high comfort represents four points.
Time frame: To be filled in at 0th and 72nd hours of nursing care.
Measured: To be filled in at 0th and 72nd hours of nursing care.
VAS (Visual Analog Scale) Pain
VAS ( Visual analog scale) On a line with '0' on one end and '10' on the other, patients will be asked to choose, explaining that 0 means no symptoms and 10 means the most severe symptoms. A high score here indicates that the patient has high pain during the treatment and care process.
Time frame: To be filled in at 0th and 72nd hours of nursing care
Measured: To be filled in at 0th and 72nd hours of nursing care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start9 Oct 2024
- Primary completion9 Apr 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery (Cardiac)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkan Sir, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769945
- Sponsor's protocol ID
- Ataturk Unıversity
- Other IDs
- TDK-2024-14325
- Status last verified
- Sep 2025
- First submitted
- 13 Dec 2024
- Last updated
- 20 Nov 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Comfort Levels of Patients Undergoing Open Heart Valve Surgery
- ClinicalTrials.gov ID
- NCT06769945
- Acronym / sponsor ID
- Ataturk Unıversity
- Conditions
- Surgery (Cardiac)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 10 Jan 2025 (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.
It is planned to determine the effect of comfort theory-based nursing care on the comfort and pain levels of patients undergoing open heart valve surgery.
- Does nursing care based on comfort theory reduce the comfort of patients undergoing open heart valve surgery?
- Does nursing care based on comfort theory reduce the pain level of patients undergoing open heart valve surgery?
- Does nursing care based on comfort theory increase the comfort level of patients undergoing open heart valve surgery?
- Does nursing care based on comfort theory increase the pain level of patients undergoing open heart valve surgery?
Detailed description
Comfort is defined as "an expected result with a complex structure within the physical, psychological, social and environmental integrity of helping the individual with his/her needs, providing peace of mind and being able to overcome problems." In his theory, Kolcaba defined comfort as "an expected result with a complex structure within the physical, psychospiritual, social and environmental integrity of helping the individual with his needs, providing peace of mind and overcoming problems. This situation affects recovery and discharge times. Studies indicate that comfort is one of the most important factors affecting the speed of recovery. The sample size of the study was determined using power analysis. As a result of the Power analysis (G*Power 3.1.9.4); when the effect size was taken as Cohen's d: 0.95, the number of samples determined for a confidence interval of 95%, a power of 95%, and a margin of error of 0.05 was determined as a total of 50 patients, with a minimum of 25 patients for each group (Experimental and Control). Considering the block randomization distributions, the study was completed with 56 patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: Nursing Care Based on Kolcaba's Comfort TheoryPatients in the experimental group will receive nursing care based on Kolcaba's Comfort Theory during their stay in the cardiovascular surgery service. After determining the comfort-oriented care needs of the patients, the General Comfort Scale will be used and individualised nursing care plans will be created in line with these needs. According to Kolcaba, standard comfort interventions and comfort interventions provided by coaching will be applied. |
| Control | No intervention | –Control group patients will receive routine nursing care in the ward environment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteering to participate in the study,
- Being 18 years of age or older,
- Being open to communication,
- Not having any obstacle in terms of consciousness and sensory organs,
- Being in the cardiovascular surgery service clinic
Key exclusion criteria (3 listed)
- Hearing and/or visual loss
- Leaving the study voluntarily
- Patients transferred from the ward environment back to the intensive care environment
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 |
|---|---|---|
| Nursing Care Based on Kolcaba's Comfort TheoryAlso: In practice, patient education, pain management, emotional support, appropriate environmental arrangements and individualised care come to the fore. Studies show that with this approach, patients' phyIn practice, patient education, pain management, emotional support, appropriate environmental arrangements and individualised care come to the fore. Studies show that with this approach, patients' physical comfort increases, anxiety levels decrease and overall satisfaction improves. It is stated that nursing care based on Kolcaba's theory offers an effective model to improve the quality of life of postoperative patients. | Behavioural | experimental |
Primary outcome
comfort
Time frame: To be filled in at 0th and 72nd hours of nursing care.
General Comfort Scale:The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. Low comfort represents one point, and high comfort represents four points. Time frame: To be filled in at 0th and 72nd hours of nursing care.
VAS (Visual Analog Scale) Pain
Time frame: To be filled in at 0th and 72nd hours of nursing care
VAS ( Visual analog scale) On a line with '0' on one end and '10' on the other, patients will be asked to choose, explaining that 0 means no symptoms and 10 means the most severe symptoms. A high score here indicates that the patient has high pain during the treatment and care process. Time frame: To be filled in at 0th and 72nd hours of nursing care
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 20 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Care Based on Kolcaba's Comfort Theory in people with Surgery (Cardiac), run by Yuzuncu Yil 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 5 inclusion and 3 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 20 Nov 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?
comfort (time frame: To be filled in at 0th and 72nd hours of nursing care.). The study lists 2 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 20 Nov 2025.