The Effect of Nursing Care Based on Kolcaba's Comfort Theory on of Intensive Care Patients
1 other identifier
interventional
80
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2024
CompletedJune 13, 2024
June 1, 2024
2 months
March 7, 2023
June 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
24 hours later
Study Arms (2)
Experimental Group
EXPERIMENTALIn 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 INTERVENTIONIn this study, the control group will receive standard care.
Interventions
Eligibility Criteria
You may qualify if:
- Volunteering to participate in the research,
- years of age or older,
- Being open to communication,
- Clear state of consciousness
- Staying in the intensive care unit for at least 24 hours
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul University - Cerrahpasalead
- Yuzuncu Yil Universitycollaborator
Study Sites (1)
Van yüzüncü yıl university
Van, 65100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aylin ÖZAKGÜL, PhD
Istanbul University - Cerrahpasa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- randomized
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
March 7, 2023
First Posted
March 30, 2023
Study Start
May 3, 2023
Primary Completion
July 5, 2023
Study Completion
June 6, 2024
Last Updated
June 13, 2024
Record last verified: 2024-06