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Active, Not Recruiting

NCT Number: NCT07366021

Comfort Care Bundle

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

ICU Bundle Care Comfort Critical Illness Disease Attributes Nursing Care Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comfort Care Bundle

Behavioral

A multicomponent comfort care bundle consisting of physical, psychosocial, environmental, and sociocultural comfort interventions delivered by ICU nurses to enhance patient comfort and reduce discomfort.

Primary outcomes

  1. The Comfort Behaviors Checklist

    Time frame: O. Day and 7. Day

    The Comfort Behaviors Checklist consists of 30 behavioral indicators. In addition, Kolcaba suggests that if listening comfort is the sole measurement tool, the individual should digitally score their pain and comfort, and that comfort should also be evaluated using a lens. Listening is coded in 42 different ways: 2, 3, 5, 7, 8, 9, 11, 12, 13, 19, 20, 21, 22, 24, 25, 27. The list is scored on a 4-point Likert scale. Parts of the list that are unsuitable for people are listed with a score of 0. The total number of questions answered is multiplied by 4 to obtain the possible score. The terminology questions are translated, and the scores of all questions are taken into account to obtain the raw comfort score. Finally, the possible comfort scores are divided by the raw scores to obtain a decimal number. The decimal part of the resulting score is expressed as a two-digit number. Higher scores indicate a high level of comfort.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Collaborators

  • Bursa City Hospital
  • Halic University
  • Tarsus University
  • Uludag University

Registry information

Official study title

The Effect of Comfort Care Packages Applied to Intensive Care Patients on Patients' Comfort Level and Physiological Parameters

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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