ICU Patient and Family Comfort Study

NCT ID: NCT00798941

Last Updated: 2010-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Pain Thirst Anxiety Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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pain intervention

music and massage for 30 minutes

Group Type EXPERIMENTAL

pain intervention

Intervention Type BEHAVIORAL

music and massage

thirst intervention

sterile water mouth spray, lip moisturizer,mouth swab

Group Type EXPERIMENTAL

mouth care

Intervention Type BEHAVIORAL

mouth spray, mouth swab, moisturizer

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mouth care

mouth spray, mouth swab, moisturizer

Intervention Type BEHAVIORAL

pain intervention

music and massage

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Palliative Care Research Center

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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U.C. San Francisco

Principal Investigators

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Kathleen A Puntillo, DNSc

Role: PRINCIPAL_INVESTIGATOR

U.C. San Francisco

Locations

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U.C. San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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08033609

Identifier Type: -

Identifier Source: org_study_id

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