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ICU Patient and Family Comfort Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00798941
Enrollment
120
Registered
2008-11-27
Start date
2009-02-28
Completion date
2010-01-31
Last updated
2010-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain, Satisfaction, Thirst

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.

Interventions

BEHAVIORALmouth care

mouth spray, mouth swab, moisturizer

BEHAVIORALpain intervention

music and massage

Sponsors

National Palliative Care Research Center
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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: * 18 years or older; * visits patient more than other family members; * closest person to patient (can be non-biological).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
patient-reported painimmediately after intervention

Secondary

MeasureTime frame
patient-reported thirstimmediately after intervention
Family-reported anxietyat end of study
Family-reported satisfactionend of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026