ICU Patient and Family Comfort Study

July 6, 2010 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Experimental: pain intervention
music and massage for 30 minutes
Behavioral: pain intervention
music and massage
Experimental: thirst intervention
sterile water mouth spray, lip moisturizer,mouth swab
Behavioral: mouth care
mouth spray, mouth swab, moisturizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient-reported pain
Time Frame: immediately after intervention
immediately after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
patient-reported thirst
Time Frame: immediately after intervention
immediately after intervention
Family-reported anxiety
Time Frame: at end of study
at end of study
Family-reported satisfaction
Time Frame: end of study
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Kathleen A Puntillo, DNSc, U.C. San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 26, 2008

First Posted (Estimate)

November 27, 2008

Study Record Updates

Last Update Posted (Estimate)

July 8, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 08033609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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