ICU Patient and Family Comfort Study

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798941
• Other study ID #: 08033609
• Status: Completed
• Phase: N/A
• First received: November 25, 2008
• Last updated: July 6, 2010
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2010
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Pain
• Satisfaction
• Thirst

Intervention

Behavioral:
• mouth care
mouth spray, mouth swab, moisturizer
• pain intervention
music and massage

Locations

Country	Name	City	State
United States	U.C. San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient-reported pain		immediately after intervention	No
Secondary	patient-reported thirst		immediately after intervention	No
Secondary	Family-reported anxiety		at end of study	No
Secondary	Family-reported satisfaction		end of study	No