Critical CareNCT05791903
The Effect of Nursing Care Based on Kolcaba's Comfort Theory on of Intensive Care Patients
A study testing Nursing Care Based on Kolcaba's Comfort Theory in people with Critical Care and Patient Satisfaction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Nurses aim to care for people who can no longer carry out their life activities and needs, and to ensure that they can continue to live their lives as well as possible. The aim is to improve the quality of life by making life more comfortable through care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Care, Patient Satisfaction
- What is being tested?
- Nursing Care Based on Kolcaba's Comfort Theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2023to 6 Jun 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,
- 18 years of age or older,
- Being open to communication,
- Clear state of consciousness
- Staying in the intensive care unit for at least 24 hours
Who cannot join
- The patient is taking sedative medication
- Being diagnosed with a sleep disorder,
- The use of sleeping pills,
- Loss of hearing and/or vision
- Use of a hearing aid
- Dependence on mechanical ventilator
- illiteracy
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, Satisfaction and Sleep Quality of Intensive Care Patients
Nurses aim to care for people who can no longer carry out their life activities and needs, and to ensure that they can continue to live their lives as well as possible. The aim is to improve the quality of life by making life more comfortable through care. Comfort in care means solving the patient's problems, being peaceful and content, and relieving pain/suffering. Kolcaba explained that comfort theory can be used as a guide to meet the comfort needs of individuals in the care process. The theory explains the concept of comfort as relaxation, refreshment and the ability to overcome problems (superiority). According to this theory, the nurse identifies the comfort needs of the patient and family and plans and implements interventions to meet these needs. There are no studies in the literature that have investigated the effect of nursing care based on Kolcaba's comfort theory on the comfort, satisfaction and sleep quality of ICU patients. The aim of this study is to determine the effect of nursing care based on Kolcaba's Comfort Theory on the comfort, satisfaction and sleep quality of ICU patients.
Read the detailed description
The study is a randomised controlled experimental study to determine the effect of nursing care based on Kolcaba's comfort theory on comfort, care satisfaction and sleep quality of intensive care patients. Power analysis was used to determine the sample size of the study. As a result of the power analysis, it was determined that a total of 44 participants, 22 participants in each group, should be reached to achieve 80% power with an effect size of 0.87, a margin of error of 0.05% and a confidence interval of 0.95%. To increase the reliability of the study, a total of 80 participants, 40 in the intervention group and 40 in the control group, should be included in the study, taking into account data loss. In this study, the control group will receive standard care and the intervention group will receive care based on Kolcaba's comfort theory. Data will be collected using the General Comfort Scale, the Newcastle Satisfaction Scale, the Richard Campbell Sleep Scale and the Comfort Behaviours Checklist.
- Conditions
- Critical Care, Patient Satisfaction
- Being tested
- Nursing Care Based on Kolcaba's Comfort Theory
- Keywords
- comfort, satisfaction, quality of sleep
- Medical subject headings
- Patient Satisfaction, Personal Satisfaction, Sleep Initiation and Maintenance Disorders
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 TheoryOther
Comfort-orientated care
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In the application process, individuals in the experimental group will receive care based on Kolcaba's comfort theory and comfort behaviour checklist during their stay in the ICU. Receives: Other: Nursing Care Based on Kolcaba's Comfort Theory |
| Control Group | No intervention | In this study, the control group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Comfort Scale
The scale, which was developed by Katharine Kolcaba in 1992 in order to determine the comfort needs of individuals, to evaluate the nursing initiatives that can provide comfort and the increase in comfort, was adapted to Turkish society by Kuğuoğlu and Karabacak in 2004.The scale, which is a four-point Likert-type scale with 48 items, was created by guiding the taxonomic structure consisting of the theoretical components of comfort, including 3 levels and 4 dimensions. Level; While the dimension is evaluated as relief (16 items), relief (17 items) and overcoming the problems (15 items); It is evaluated in three parts: physical (12 items), psychospritual (13 items) and socio-cultural (10 items). Negative expressions in the scale are calculated by reverse coding during the evaluation phase. While the lowest total score that can be obtained from the scale is 48, the highest total score is 192.
Measured: 24 hours later
Comfort Behaviors Checklist
The Comfort Behaviour Checklist was developed by Katharina Kolcaba in 1989. The checklist is completed by the observer when it is not possible for the person to complete the questionnaire. The Comfort Behaviour Checklist consists of 30 behavioural indicators. In addition to these, Kolcaba suggests that if the checklist is the only tool used to measure comfort, the individual should give a numerical score for pain and comfort so that comfort can be objectively assessed.
Measured: 24 hours later
Richard-Campbell Sleep Scale
The scale was developed by Richards et al. (1987) to assess sleep quality in intensive care units (Richards, 1987; Richards et al., 2000). The RQAS includes six items (depth of sleep, time to fall asleep, frequency of awakening, duration of wakefulness, quality of sleep and ambient noise level). The scale score is evaluated with the sum of the first five items. A score of 25 and below indicates very poor sleep, while a minimum score of 76 and above indicates very good sleep.
Measured: 24 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start3 May 2023
- Primary completion5 Jul 2023
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Model description
- Experimental, randomised controlled, single-blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Yuzuncu Yil University
- Responsible party
- Principal investigator, Ebubekir Kaplan, Istanbul University - Cerrahpasa
- Investigators
- Aylin ÖZAKGÜL, PhD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791903
- Sponsor's protocol ID
- Ebkrkpln
- Status last verified
- Jun 2024
- First submitted
- 7 Mar 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. 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, Satisfaction and Sleep Quality of Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05791903
- Acronym / sponsor ID
- Ebkrkpln
- Conditions
- Critical Care, Patient Satisfaction
- Keywords
- comfort, satisfaction, quality of sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Yuzuncu Yil University
- Study start
- 3 May 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 30 Mar 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.
Nurses aim to care for people who can no longer carry out their life activities and needs, and to ensure that they can continue to live their lives as well as possible. The aim is to improve the quality of life by making life more comfortable through care. Comfort in care means solving the patient's problems, being peaceful and content, and relieving pain/suffering. Kolcaba explained that comfort theory can be used as a guide to meet the comfort needs of individuals in the care process. The theory explains the concept of comfort as relaxation, refreshment and the ability to overcome problems (superiority). According to this theory, the nurse identifies the comfort needs of the patient and family and plans and implements interventions to meet these needs. There are no studies in the literature that have investigated the effect of nursing care based on Kolcaba's comfort theory on the comfort, satisfaction and sleep quality of ICU patients. The aim of this study is to determine the effect of nursing care based on Kolcaba's Comfort Theory on the comfort, satisfaction and sleep quality of ICU patients.
Detailed description
The study is a randomised controlled experimental study to determine the effect of nursing care based on Kolcaba's comfort theory on comfort, care satisfaction and sleep quality of intensive care patients. Power analysis was used to determine the sample size of the study. As a result of the power analysis, it was determined that a total of 44 participants, 22 participants in each group, should be reached to achieve 80% power with an effect size of 0.87, a margin of error of 0.05% and a confidence interval of 0.95%. To increase the reliability of the study, a total of 80 participants, 40 in the intervention group and 40 in the control group, should be included in the study, taking into account data loss. In this study, the control group will receive standard care and the intervention group will receive care based on Kolcaba's comfort theory. Data will be collected using the General Comfort Scale, the Newcastle Satisfaction Scale, the Richard Campbell Sleep Scale and the Comfort Behaviours Checklist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental, randomised controlled, single-blind study
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Nursing Care Based on Kolcaba's Comfort TheoryIn the application process, individuals in the experimental group will receive care based on Kolcaba's comfort theory and comfort behaviour checklist during their stay in the ICU. |
| Control Group | No intervention | –In this study, the control group will receive standard care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteering to participate in the research,
- 18 years of age or older,
- Being open to communication,
- Clear state of consciousness
- Staying in the intensive care unit for at least 24 hours
Key exclusion criteria (7 listed)
- The patient is taking sedative medication
- Being diagnosed with a sleep disorder,
- The use of sleeping pills,
- Loss of hearing and/or vision
- Use of a hearing aid
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 TheoryComfort-orientated care | Other | Experimental Group |
Primary outcome
General Comfort Scale
Time frame: 24 hours later
The scale, which was developed by Katharine Kolcaba in 1992 in order to determine the comfort needs of individuals, to evaluate the nursing initiatives that can provide comfort and the increase in comfort, was adapted to Turkish society by Kuğuoğlu and Karabacak in 2004.The scale, which is a four-point Likert-type scale with 48 items, was created by guiding the taxonomic structure consisting of the theoretical components of comfort, including 3 levels and 4 dimensions. Level; While the dimension is evaluated as relief (16 items), relief (17 items) and overcoming the problems (15 items); It is evaluated in three parts: physical (12 items), psychospritual (13 items) and socio-cultural (10 items). Negative expressions in the scale are calculated by reverse coding during the evaluation phase. While the lowest total score that can be obtained from the scale is 48, the highest total score is 192.
Comfort Behaviors Checklist
Time frame: 24 hours later
The Comfort Behaviour Checklist was developed by Katharina Kolcaba in 1989. The checklist is completed by the observer when it is not possible for the person to complete the questionnaire. The Comfort Behaviour Checklist consists of 30 behavioural indicators. In addition to these, Kolcaba suggests that if the checklist is the only tool used to measure comfort, the individual should give a numerical score for pain and comfort so that comfort can be objectively assessed.
Richard-Campbell Sleep Scale
Time frame: 24 hours later
The scale was developed by Richards et al. (1987) to assess sleep quality in intensive care units (Richards, 1987; Richards et al., 2000). The RQAS includes six items (depth of sleep, time to fall asleep, frequency of awakening, duration of wakefulness, quality of sleep and ambient noise level). The scale score is evaluated with the sum of the first five items. A score of 25 and below indicates very poor sleep, while a minimum score of 76 and above indicates very good sleep.
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 13 Jun 2024.
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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.
Aylin ÖZAKGÜL, PhD study director
Istanbul University - Cerrahpasa
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 Critical Care and Patient Satisfaction, run by Istanbul University - Cerrahpasa 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 7 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 13 Jun 2024. 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?
General Comfort Scale (time frame: 24 hours later). The study lists 3 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 13 Jun 2024.