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Completed

NCT Number: NCT00798941

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Behavior Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Personal Satisfaction Satisfaction Signs and Symptoms Thirst

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U.C. San Francisco

San Francisco, California, 94143-0610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mouth care

Behavioral

mouth spray, mouth swab, moisturizer

pain intervention

Behavioral

music and massage

Primary outcomes

  1. patient-reported pain

    Time frame: immediately after intervention

Secondary outcomes

  1. patient-reported thirst

    Time frame: immediately after intervention

  2. Family-reported anxiety

    Time frame: at end of study

  3. Family-reported satisfaction

    Time frame: end of study

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Palliative Care Research Center

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 27, 2008
Registry last updated
Jul 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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