Thirst Clinical Trial
Official title:
Palliation of Thirst in ICU Patients
Patients in Intensive Care Units are often extremely thirsty due to their medicines, illness, treatments or medicines that they receive. This study will test whether patients who receive a easy to implement intervention for thirst will have greater relief from thirst than a group of patients who do not receive the intervention. The study will also identify the most important factors that make ICU patients thirsty so that future research studies can test how to relieve those factors and/or make interventions for thirst more readily available.
This study will test the efficacy of an innovative, inexpensive, resource-efficient
treatment for thirst -- one of the most pervasive, intense, unrecognized, and under-treated
symptoms suffered by critically ill patients in Intensive Care Units (ICUs). The first aim
of this single-blinded, randomized clinical trial is to test a non-pharmacologic
intervention for thirst in ICU patients. The intervention is a combination therapy treatment
(CTT) for thirst that includes the use of sterile water mouth sprays, sterile water swabs,
and menthol-based lip and tongue moisturizer. The second aim of the study is to examine
demographic, environmental, and health and illness factors that increase an ICU patient's
risk profile for thirst. Aim #1 hypotheses: (1) Thirst intensity and distress will decrease
significantly in ICU patients who receive a CTT for thirst compared to those who receive
research team observation. (2) Subjective (e.g., dry mouth) and objective (e.g., cracked
lips) thirst-related characteristics will decrease significantly in ICU patients who receive
a CCT for thirst compared to those who receive research team observation. Aim #2 hypotheses:
(1) A significant association will be found between presence of thirst and certain risk
factors for thirst, e.g., serum osmolality, hydration status, and administration of certain
medications, e.g., opioids. (2) A significant association will be found between the
intensity of thirst and certain risk factors for thirst, e.g., serum osmolality, hydration
status, and administration of certain medications, e.g., opioids.
The sample will be 245 ICU patients in one Experimental and two Control groups. Those with
thirst will be randomized to either the Experimental or the Control 1 group. The
Experimental group will receive the CTT; the Control 1 group will receive research team
observation. The Control 2 group patients who reported no thirst will be compared to the
Control 1 group on characteristics associated with the presence and intensity of thirst.
Multilevel linear regression models will be employed to test the difference in the linear
change trajectories between the treatment and control groups. Multiple logistic regression
analysis and multiple linear regression analysis will be used to determine association of
risk factors with the presence and intensity of thirst, respectively.
Results will contribute empirical data needed to stimulate a far overdue nursing practice
change for the treatment of thirst in ICUs. Results will also identify a risk profile for
thirst that will be an important target for future research of thirst in ICU patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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