ICU Patient and Family Comfort Study
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to evaluate family-led interventions for Intensive Care Unit (ICU) patients' symptoms (i.e., pain and thirst) that will involve ICU patients' family members in the non-pharmacological management of these symptoms. This family involvement may help to ameliorate not only patients' symptoms but also the families' symptoms and promote family satisfaction with ICU care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Feb 2009
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
November 25, 2008
CompletedFirst Posted
Study publicly available on registry
November 27, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJuly 8, 2010
June 1, 2010
11 months
November 25, 2008
July 6, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
patient-reported pain
immediately after intervention
Secondary Outcomes (3)
patient-reported thirst
immediately after intervention
Family-reported anxiety
at end of study
Family-reported satisfaction
end of study
Study Arms (3)
pain intervention
EXPERIMENTALmusic and massage for 30 minutes
thirst intervention
EXPERIMENTALsterile water mouth spray, lip moisturizer,mouth swab
control
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Patient:
- in ICU for at least 24 hours;
- adult;
- able to self-report;
- pain and thirst greater than 3 on 0-10 numeric rating scale;
- English-speaking.
- Family member:
- years or older;
- visits patient more than other family members;
- closest person to patient (can be non-biological).
You may not qualify if:
- Patient:
- in ICU for at less than 24 hours;
- non-adult;
- unable to self-report;
- no pain and thirst greater than 3 on 0-10 numeric rating scale;
- non-English-speaking.
- Family member:
- younger than 18 years;
- visits patient less than other family members;
- not closest person to patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
U.C. San Francisco
San Francisco, California, 94143-0610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen A Puntillo, DNSc
U.C. San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 25, 2008
First Posted
November 27, 2008
Study Start
February 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
July 8, 2010
Record last verified: 2010-06