ICU Patient and Family Comfort Study

Not Applicable

Completed

• Conditions: Pain; Thirst; Anxiety; Satisfaction
• Interventions: Behavioral: pain intervention; Behavioral: mouth care

• Registration Number: NCT00798941
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-11-27
• Study Start: 2009-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-06
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pain intervention	pain intervention	music and massage for 30 minutes
thirst intervention	mouth care	sterile water mouth spray, lip moisturizer,mouth swab

Primary Outcome Measures

Name	Time	Method
patient-reported pain	immediately after intervention

Secondary Outcome Measures

Name	Time	Method
patient-reported thirst	immediately after intervention
Family-reported anxiety	at end of study
Family-reported satisfaction	end of study

Trial Locations

Locations (1)

U.C. San Francisco; 🇺🇸 San Francisco, California, United States