PainNCT00798941
ICU Patient and Family Comfort Study
A study testing mouth care and pain intervention in people with Pain and Thirst, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- mouth care and pain intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- Family member:
- 18 years or older;
- visits patient more than other family members;
- closest person to patient (can be non-biological).
Who cannot join
- 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.
Show all 10Show fewer
- Family member:
- younger than 18 years;
- visits patient less than other family members;
- not closest person to patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.C. San Francisco
San Francisco, California, 94143-0610
About this 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.
- Conditions
- Pain, Thirst, Anxiety, Satisfaction
- Being tested
- mouth care, pain intervention
- Medical subject headings
- Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mouth careBehavioural
mouth spray, mouth swab, moisturizer
pain interventionBehavioural
music and massage
| Study group | Role | What they receive |
|---|---|---|
| pain intervention | Experimental | music and massage for 30 minutes Receives: Behavioral: pain intervention |
| thirst intervention | Experimental | sterile water mouth spray, lip moisturizer,mouth swab Receives: Behavioral: mouth care |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-reported pain
Measured: immediately after intervention
Secondary outcomes (3)
patient-reported thirst
Measured: immediately after intervention
Family-reported anxiety
Measured: at end of study
Family-reported satisfaction
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Palliative Care Research Center
- Investigators
- Kathleen A Puntillo, DNSc, Principal investigator, U.C. San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798941
- Sponsor's protocol ID
- 08033609
- Status last verified
- Jun 2010
- First submitted
- 25 Nov 2008
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Patient and Family Comfort Study
- ClinicalTrials.gov ID
- NCT00798941
- Acronym / sponsor ID
- 08033609
- Conditions
- Pain, Thirst, Anxiety, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Palliative Care Research Center
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pain intervention | Experimental | Behavioral: pain interventionmusic and massage for 30 minutes |
| thirst intervention | Experimental | Behavioral: mouth caresterile water mouth spray, lip moisturizer,mouth swab |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient:
- Family member:
Key exclusion criteria (10 listed)
- Patient:
- Family member:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mouth caremouth spray, mouth swab, moisturizer | Behavioural | thirst intervention |
| pain interventionmusic and massage | Behavioural | pain intervention |
Primary outcome
patient-reported pain
Time frame: immediately after intervention
3 secondary outcomes
patient-reported thirst
Time frame: immediately after intervention
Family-reported anxiety
Time frame: at end of study
Family-reported satisfaction
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen A Puntillo, DNSc principal investigator
U.C. San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mouth care and pain intervention in people with Pain and Thirst, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient-reported pain (time frame: immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010.