ICU Patient and Family Comfort Study

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: Pain; Anxiety; Satisfaction; Thirst
• Intervention / Treatment: Behavioral: pain intervention; Behavioral: mouth care

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	immediately after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

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