ICU Patient and Family Comfort Study

This study is not yet open for participant recruitment.

Verified by University of California, San Francisco, November 2008

First Received: November 25, 2008 Last Updated: November 26, 2008 History of Changes

Sponsors and Collaborators:	University of California, San Francisco National Palliative Care Research Center
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00798941

Purpose

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.

Condition	Intervention
Pain Thirst Anxiety Satisfaction	Behavioral: mouth care Behavioral: pain intervention

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

patient-reported pain [ Time Frame: immediately after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

patient-reported thirst [ Time Frame: immediately after intervention ] [ Designated as safety issue: No ]
Family-reported anxiety [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Family-reported satisfaction [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	January 2009

Arms	Assigned Interventions
pain intervention: Experimental music and massage for 30 minutes	Behavioral: pain intervention music and massage
thirst intervention: Experimental sterile water mouth spray, lip moisturizer,mouth swab	Behavioral: mouth care mouth spray, mouth swab, moisturizer
control: No Intervention

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798941

Contacts

Contact: Shoshana R Arai, PhD	415 476 0966	shoshana.arai@nursing.ucsf.edu
Contact: Kathleen A Puntillo, DNSc	415 476 1844	kathleen.puntillo@nursing.ucsf.edu

Locations

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

Sponsors and Collaborators

University of California, San Francisco

National Palliative Care Research Center

Investigators

Principal Investigator:

Kathleen A Puntillo, DNSc

U.C. San Francisco

More Information

No publications provided

Responsible Party:	U.C. San Francisco ( Kathleen Puntillo )
Study ID Numbers:	08033609
Study First Received:	November 25, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00798941 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on September 10, 2009