FEVERNCT01038219
Reliability of Subjective Assessment of Fever by Parents and Health Care Providers in Children and Adolescents
An observational study of FEVER, run by Meir Medical Center at 2 sites in Israel.
Trial summary
Background: Fever is a widespread symptom in many diseases. Therefore, its value and diagnostic importance are well known. Fever in children is one of the common reasons for a visit to the pediatrician. Also, taking temperature is a very simple action and accessible to the general public. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- FEVER
- How many people
- 520 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2010to Apr 2015
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children ages 0-18 years Boys and girls
Who may be able to join
- The estimates and the measurements will be carried out on children who are referred to an emergency unit and who are hospitalized in the pediatric department-- both boys and girls of all ages. A patient might be measured several times.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
About this study
Background: Fever is a widespread symptom in many diseases. Therefore, its value and diagnostic importance are well known. Fever in children is one of the common reasons for a visit to the pediatrician. Also, taking temperature is a very simple action and accessible to the general public.
Temperature is measured in various parts of the body by using medical equipment. The type of method and thermometer varies according to the patient's age but often temperature is estimated by touch. Temperature measurement serves as a means for monitoring the patient's condition. For that reason, supervision of the body temperature is an important factor in the process of taking medical decisions.
Read more
Study rationale: the parent is often asked if the child's temperature has been taken. The most frequent answer is: "I didn't measure, but I felt that he has a temperature". The few studies carried out on this subject showed that many parents used touch to evaluate the child's body temperature, especially in infants.
Some studies checked the reliability of parents to estimate the child's body temperature by touch only. To the best of our knowledge, the reliability of medical staff (nurses) to estimate the child's body temperature by touch has never been studied.
The aim of the current study is to investigate whether parents and nurses correctly estimate the child's body temperature by touch, as compared to thermometer measurement during the pediatric unit's routine work.
Read the detailed description
1000 estimates and measurements of children's body temperatures will be carried out by parents and nurses in the pediatric emergency unit and pediatric department as part of the routine work. The estimates and the measurements will be carried out on both boys and girls of all ages. A patient might be measured several times.
The measurements will be gathered in the course of one year. Before the routine taking of temperature, the accompanying parent will be asked to estimate the patient's temperature by feeling his forehead (with the back of the hand, the palm, lips). The parent will record his evaluation (without telling the nurse). Afterwards the nurse will perform a similar evaluation (excluding the lip test), record it, and then the routine temperature measurement will be taken and recorded.
Medical Equipment The temperature will be taken with the existing equipment in the emergency ward and in the children's ward. A rectal measurement will be taken in the case of children under two years old. Children over two will be measured orally. The temperature of children suffering from diarrhea and vomiting will be taken with an ordinary mercury thermometer. All other measurements will be made using an electronic, mobile thermometer manufactured by the Filac Company, (FasTemp electronic thermometer) routinely used in the emergency ward and pediatric departments.
- Conditions
- FEVER
- Keywords
- fever, children, SUBJECTIVE ASSESSMENT
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| fever measurements | 1000 estimates and measurements of children's body temperatures will be carried out by parents and nurses in children's emergency and pediatric units as part of the routine work. The estimates and the measurements will be carried out on children who are referred to an emergency unit and who are hospitalized in the pediatric department-- both boys and girls of all ages. A patient might be measured several times. The measurements will be gathered in the course of one year. Before the routine taking of temperature, the accompanying parent will be asked to estimate the patient's temperature by feeling his forehead (with the back of the hand, the palm, lips). The parent will record his evaluation (without telling the nurse). Afterwards the nurse will do a similar evaluation (excepting the lip test), record it, and then the routine temperature measurement will be taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective assessment of fever by both parents and medical personnel will be unreliable
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FEVERStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038219
- Sponsor's protocol ID
- MMC129-09CTIL
- Status last verified
- May 2014
- First submitted
- 20 Dec 2009
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Subjective Assessment of Fever by Parents and Health Care Providers in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01038219
- Acronym / sponsor ID
- MMC129-09CTIL
- Conditions
- FEVER
- Keywords
- fever, children, SUBJECTIVE ASSESSMENT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Dec 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.
Background: Fever is a widespread symptom in many diseases. Therefore, its value and diagnostic importance are well known. Fever in children is one of the common reasons for a visit to the pediatrician. Also, taking temperature is a very simple action and accessible to the general public.
Temperature is measured in various parts of the body by using medical equipment. The type of method and thermometer varies according to the patient's age but often temperature is estimated by touch. Temperature measurement serves as a means for monitoring the patient's condition. For that reason, supervision of the body temperature is an important factor in the process of taking medical decisions.
Study rationale: the parent is often asked if the child's temperature has been taken. The most frequent answer is: "I didn't measure, but I felt that he has a temperature". The few studies carried out on this subject showed that many parents used touch to evaluate the child's body temperature, especially in infants.
Some studies checked the reliability of parents to estimate the child's body temperature by touch only. To the best of our knowledge, the reliability of medical staff (nurses) to estimate the child's body temperature by touch has never been studied.
The aim of the current study is to investigate whether parents and nurses correctly estimate the child's body temperature by touch, as compared to thermometer measurement during the pediatric unit's routine work.
Detailed description
1000 estimates and measurements of children's body temperatures will be carried out by parents and nurses in the pediatric emergency unit and pediatric department as part of the routine work. The estimates and the measurements will be carried out on both boys and girls of all ages. A patient might be measured several times.
The measurements will be gathered in the course of one year. Before the routine taking of temperature, the accompanying parent will be asked to estimate the patient's temperature by feeling his forehead (with the back of the hand, the palm, lips). The parent will record his evaluation (without telling the nurse). Afterwards the nurse will perform a similar evaluation (excluding the lip test), record it, and then the routine temperature measurement will be taken and recorded.
Medical Equipment The temperature will be taken with the existing equipment in the emergency ward and in the children's ward. A rectal measurement will be taken in the case of children under two years old. Children over two will be measured orally. The temperature of children suffering from diarrhea and vomiting will be taken with an ordinary mercury thermometer. All other measurements will be made using an electronic, mobile thermometer manufactured by the Filac Company, (FasTemp electronic thermometer) routinely used in the emergency ward and pediatric departments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fever measurements | – | –1000 estimates and measurements of children's body temperatures will be carried out by parents and nurses in children's emergency and pediatric units as part of the routine work. The estimates and the measurements will be carried out on children who are referred to an emergency unit and who are hospitalized in the pediatric department-- both boys and girls of all ages. A patient might be measured several times. The measurements will be gathered in the course of one year. Before the routine taking of temperature, the accompanying parent will be asked to estimate the patient's temperature by feeling his forehead (with the back of the hand, the palm, lips). The parent will record his evaluation (without telling the nurse). Afterwards the nurse will do a similar evaluation (excepting the lip test), record it, and then the routine temperature measurement will be taken. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children ages 0-18 years Boys and girls
Key inclusion criteria (1 listed)
- The estimates and the measurements will be carried out on children who are referred to an emergency unit and who are hospitalized in the pediatric department-- both boys and girls of all ages. A patient might be measured several times.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
subjective assessment of fever by both parents and medical personnel will be unreliable
Time frame: one year
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 14 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FEVER, run by Meir Medical Center at 2 sites in Israel.
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 1 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
subjective assessment of fever by both parents and medical personnel will be unreliable (time frame: one year). 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 14 Apr 2015.