Comfort Care Bundle

Akdeniz University

Status: Active, not recruiting

Conditions: Bundle Care; Critical Illness; ICU; Comfort; Nursing Care

Treatments: Behavioral: Comfort Care Bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT07366021

TBAEK-354

Details and patient eligibility

About

Intensive care units (ICUs) are specialized units where numerous complex treatment and care procedures are applied. In these units, critically ill patients are exposed to stressful conditions and experience significant pain and other discomforts stemming from multiple internal and external factors that can alter their quality of life and trigger symptoms of post-traumatic stress disorder (PTSD). These discomforts can have various short-term or long-term consequences for patients after discharge from the ICU, such as anxiety and/or depression or PTSD, which can affect their quality of life. Therefore, knowing the negative factors affecting patient comfort in the ICU, as well as measuring patient comfort and eliminating or reducing these factors through comfort care, is crucial in reducing morbidity and mortality rates in patients. It is noteworthy that there is no specific care package in the literature aimed at improving ICU-specific comfort. Accordingly, this study aims to develop a "Comfort Care Package" to improve the comfort level of ICU patients. The research population will consist of all patients aged 18-65 years admitted to the intensive care units of Bursa City Hospital. This study will test the effect of the developed "Comfort Care Package" on the comfort level and physiological parameters of 88 ICU patients (control group=44 and study group=44) who meet the inclusion criteria and whose data were calculated using the G*Power 3.1 program. The study will begin with the collection of data from the control group. This group will receive routine ICU care. The study group will receive the Comfort Care Package. It is anticipated that the ICU-specific comfort care package developed within the scope of this study will make significant contributions to the creation of nursing care plans aimed at increasing the comfort levels of critically ill individuals. Therefore, in patients with improved comfort, targeted recovery outcomes may increase, mortality rates may decrease, and thus public health may be sustained.

Enrollment: 88 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Staying in the intensive care unit for at least 48 hours
• Communication language being Turkish
• For non-intubated patients, GCS > 12; for intubated patients, GCS > 10 + intubated (verbal response)

Exclusion criteria

• Hearing and hearing problems
• History or diagnosis of cognitive impairment, mental illness, nervous system disorders, brain injury
• RASS score >1
• Delirium
• Admitted with a diagnosis of alcohol/drug intoxication
• Pregnant
• Hemodynamically unstable patients receiving high-dose inotropic/vasopressor drug therapy
• Transfer to another ICU
• Emergency discharge from the ICU for any reason

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Intervention-Behavioral

Experimental group

Description:

Comfort Care Bundle Contents: * Ensure and maintain Physical Comfort (Prevent and manage pain, support daily living activities) * Ensure and maintain Psychospiritual Comfort (Manage agitation-sedation and delirium) * Ensure and maintain Environmental Comfort (Arrange the environment to facilitate the patient's adaptation) * Ensure and maintain Sociocultural Comfort (Enable and maintain the patient's interaction with their environment, ensure family participation in care)

Treatment:

Behavioral: Comfort Care Bundle

Routine ICU care group

No Intervention group

Description:

To avoid negatively impacting the data collection environment in the research (preventing issues such as bias by the nurse performing the procedure, ethical dilemmas, etc.), the study will begin with the collection of data from a control group. The control group will receive routine nursing care from the clinic.