PainNCT00935207
Study of the Impact of a Pain Diary in Pediatric Patients
An observational study of Pain, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to show the impact of a pain diary on the communication of pain by pediatric patients. Participants will be given a pain diary after consent and asked to complete the record each time they have pain. Read more about this study
- Who is it for?
- Ages 3 to 19 years
- Conditions the study is for
- Pain
- What is being tested?
- Pediatric Pain Diary
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2011
- Phase
- Observational
- 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 3 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.
Who may be able to join
- Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.
Who cannot join
- Admitted to the Pediatric Intensive Care Unit
- Surgical patients, defined as patients having surgery since admission other than minor procedures
- Patients anticipated to receive pain medication for less than 24 hours
- Patients unable to verbally communicate their pain
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: The Impact of a Pain Diary on the Communication of Pain in Pediatric Patients
The purpose of this study is to show the impact of a pain diary on the communication of pain by pediatric patients. Participants will be given a pain diary after consent and asked to complete the record each time they have pain. A survey about the efficacy of the pain diary will be taken prior to discharge by the nurse, physician, patient and parents. The hypothesis is that the pain diary will improve the communication.
- Conditions
- Pain
- Being tested
- Pediatric Pain Diary
- Keywords
- Pain, Pediatric Pain, Pain Diary, Pediatric Pain Measurement, Pain Measurement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Pain DiaryOther
Pain diary designed for pediatric patients
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Pain Diary | Patients will be give a pain diary to complete. Receives: Other: Pediatric Pain Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Survey
Measured: Hospital discharge
Parent Survey
Measured: Hospital Discharge
Nurse Survey
Measured: Hospital Discharge
Physician Survey
Measured: Hospital Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Poor enrollment and data collection
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.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Ostrenga, University of Mississippi Medical Center
- Investigators
- Andrew Ostrenga, Pharm.D., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935207
- Sponsor's protocol ID
- 2009-0054
- Status last verified
- May 2013
- First submitted
- 17 Jun 2009
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Pain Diary on the Communication of Pain in Pediatric Patients
- ClinicalTrials.gov ID
- NCT00935207
- Acronym / sponsor ID
- 2009-0054
- Conditions
- Pain
- Keywords
- Pain, Pediatric Pain, Pain Diary, Pediatric Pain Measurement, Pain Measurement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor enrollment and data collection
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Jul 2009 (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 show the impact of a pain diary on the communication of pain by pediatric patients. Participants will be given a pain diary after consent and asked to complete the record each time they have pain. A survey about the efficacy of the pain diary will be taken prior to discharge by the nurse, physician, patient and parents. The hypothesis is that the pain diary will improve the communication.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Pain Diary | – | Other: Pediatric Pain DiaryPatients will be give a pain diary to complete. |
Who may qualify
- Ages
- 3 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.
Key inclusion criteria (1 listed)
- Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.
Key exclusion criteria (4 listed)
- Admitted to the Pediatric Intensive Care Unit
- Surgical patients, defined as patients having surgery since admission other than minor procedures
- Patients anticipated to receive pain medication for less than 24 hours
- Patients unable to verbally communicate their pain
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 |
|---|---|---|
| Pediatric Pain DiaryPain diary designed for pediatric patients | Other | Pediatric Pain Diary |
Primary outcome
Child Survey
Time frame: Hospital discharge
Parent Survey
Time frame: Hospital Discharge
Nurse Survey
Time frame: Hospital Discharge
Physician Survey
Time frame: Hospital Discharge
Results and safety
The study was stopped early (reason given: Poor enrollment and data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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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.
Andrew Ostrenga, Pharm.D. principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by University of Mississippi Medical Center 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 May 2013. 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 was stopped early (reason given: Poor enrollment and data collection). Results are not available in the source record.
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?
Child Survey (time frame: Hospital discharge). The study lists 4 primary outcomes in all. 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 3 May 2013.