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CompletedNCT00798941Updated Jul 8, 2010

ICU Patient and Family Comfort Study

An interventional study of mouth care and pain intervention in Pain, Thirst and Anxiety, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-08.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
  • Thirst
  • Anxiety
  • Satisfaction
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    pain intervention

    music and massage for 30 minutes

    Behavioral: pain intervention

  • Experimental
    thirst intervention

    sterile water mouth spray, lip moisturizer,mouth swab

    Behavioral: mouth care

  • No intervention
    control

Interventions

  • Behavioralmouth care

    mouth spray, mouth swab, moisturizer

  • Behavioralpain intervention

    music and massage

06

What researchers measure

Primary outcomes

  1. patient-reported pain

    Time frame: immediately after intervention

Secondary outcomes

  1. patient-reported thirst

    Time frame: immediately after intervention

  2. Family-reported anxiety

    Time frame: at end of study

  3. Family-reported satisfaction

    Time frame: end of study

07

Study locations

1 site
  • U.C. San Francisco
    San Francisco, California 94143-0610, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00798941
Lead sponsor
University of California, San Francisco
Collaborators
National Palliative Care Research Center
First posted
Nov 27, 2008
Start date
Feb 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Jul 8, 2010

Study contacts

Kathleen A Puntillo, DNSc
principal investigator · U.C. San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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