Focus of the Study Includes Patients in PainNCT02001454
Quality of Pain Management at the Ziv Medical Center
An observational study of Focus of the Study Includes Patients in Pain, run by Ziv Hospital at 1 site in Israel.
Trial summary
The purpose of this study is to compare attitudes and knowledge of the staff of various departments in our Medical Center in regards to pain treatment. With the results of our survey we will then draw up a protocol on pain management. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Focus of the Study Includes Patients in Pain
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2013to May 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population includes patients in pain.
Who may be able to join
- Staff from the Ziv Medical Center and patients
Who cannot join
- Staff members that do not deal with pain treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical Center
Safed, 33100
Littal Rubin, RN, +97246828912, littal.r@ziv.health.gov.il
David Rothem, MD
About this study
The purpose of this study is to compare attitudes and knowledge of the staff of various departments in our Medical Center in regards to pain treatment. With the results of our survey we will then draw up a protocol on pain management.
Read the detailed description
Our belief is that the establishment of a pain protocol at the Ziv Medical Center will improve effectiveness of pain treatment. The present study involves surveying the current knowledge and attitudes of caregivers who are responsible for evaluating pain in patients and subsequent treatment in various departments of the hospital without a pain protocol.
According to the IASP (International Association for the Study of Pain) :" Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". According to WHO, assessment is necessary in every situation that involves pain, excluding pain that is life threatening. Valid and reliable assessment is essential for effective pain management. The very nature of pain makes it impossible to measure objectively. There are different types of pain, and as caregivers, we need to diagnose the pain accurately in order that each patient gets the most effective treatment and continued evaluations, as needed. When caregivers decide on a treatment for pain, they are relying on the relatively objective VAS (Visual Analogue Scale.) According to recent studies most patients were dissatisfied with the pain treatment they had received. Approximately eighty percent of patients who present to emergency departments worldwide come because of pain.
Often the patient and the caregiver have different ideas about what pain is and how to treat it. Cultural differences, gender differences, even age differences may affect reactions of both the caretaker and the patient. There are many ways to treat pain, and various reasons for how people react to pain.
The present study is designed to measure the knowledge and attitudes of caregivers and in regard to the pain of their patients. An assessment of patient satisfaction to pain management will be also be performed.
Staff members working in wards involved with pain will be asked to fill out anonymous questionnaires concerning knowledge and attitudes toward pain. Patients will also be asked to fill out anonymous questionnaires in regard to their pain treatment. Informed consent will be requested. Responses will be collated and recorded. A future study is planned using a new pain protocol. The questionnaires will be repeated after the protocol has been in place for 12 months, at which time responses will be compared.
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 |
|---|---|---|
| Patients in pain | There is no intervention, only questionnaires for the patient | |
| Attending Physicians and Nurses | The staff physicians and nurses will also fill out a questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of pain treatment for the patient
Measured: A 6-month assessment will be performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study Includes Patients in 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Eliya Rothem, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001454
- Sponsor's protocol ID
- 0032-13
- Status last verified
- Nov 2013
- First submitted
- 27 Nov 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Pain Management at the Ziv Medical Center
- ClinicalTrials.gov ID
- NCT02001454
- Acronym / sponsor ID
- 0032-13
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Nov 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 4 Dec 2013 (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 compare attitudes and knowledge of the staff of various departments in our Medical Center in regards to pain treatment. With the results of our survey we will then draw up a protocol on pain management.
Detailed description
Our belief is that the establishment of a pain protocol at the Ziv Medical Center will improve effectiveness of pain treatment. The present study involves surveying the current knowledge and attitudes of caregivers who are responsible for evaluating pain in patients and subsequent treatment in various departments of the hospital without a pain protocol.
According to the IASP (International Association for the Study of Pain) :" Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". According to WHO, assessment is necessary in every situation that involves pain, excluding pain that is life threatening. Valid and reliable assessment is essential for effective pain management. The very nature of pain makes it impossible to measure objectively. There are different types of pain, and as caregivers, we need to diagnose the pain accurately in order that each patient gets the most effective treatment and continued evaluations, as needed. When caregivers decide on a treatment for pain, they are relying on the relatively objective VAS (Visual Analogue Scale.) According to recent studies most patients were dissatisfied with the pain treatment they had received. Approximately eighty percent of patients who present to emergency departments worldwide come because of pain.
Often the patient and the caregiver have different ideas about what pain is and how to treat it. Cultural differences, gender differences, even age differences may affect reactions of both the caretaker and the patient. There are many ways to treat pain, and various reasons for how people react to pain.
The present study is designed to measure the knowledge and attitudes of caregivers and in regard to the pain of their patients. An assessment of patient satisfaction to pain management will be also be performed.
Staff members working in wards involved with pain will be asked to fill out anonymous questionnaires concerning knowledge and attitudes toward pain. Patients will also be asked to fill out anonymous questionnaires in regard to their pain treatment. Informed consent will be requested. Responses will be collated and recorded. A future study is planned using a new pain protocol. The questionnaires will be repeated after the protocol has been in place for 12 months, at which time responses will be compared.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in pain | – | –There is no intervention, only questionnaires for the patient |
| Attending Physicians and Nurses | – | –The staff physicians and nurses will also fill out a questionnaire |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population includes patients in pain.
Key inclusion criteria (1 listed)
- Staff from the Ziv Medical Center and patients
Key exclusion criteria (1 listed)
- Staff members that do not deal with pain treatment
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
Improvement of pain treatment for the patient
Time frame: A 6-month assessment will be performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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.
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 Focus of the Study Includes Patients in Pain, run by Ziv Hospital at 1 site 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: status not confirmed, as of the sponsor's last update on 4 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of pain treatment for the patient (time frame: A 6-month assessment will be performed). 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 4 Dec 2013.