PainD-PSYNCT02822430
Pain in Psychiatry : Impact on Length of Hospital Stays
An observational study of Pain, run by University Hospital, Toulouse at 1 site in France.
Trial summary
For several decades, authors are interested in the existence and meaning of painful symptoms in a population of psychiatric inpatients. But, to date, studies specifically focused on the impact of pain in patient populations in psychiatric hospitals are few. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Pain scales
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with psychiatric disorders
Who may be able to join
- Patient eighteen years old
- Patient hospitalized in psychiatric service at Toulouse University Hospital
- Informed consent signed
Who cannot join
- Patient treated with maintenance sismotherapy
Trial locations and contacts
1 site in 1 country.
About this study
For several decades, authors are interested in the existence and meaning of painful symptoms in a population of psychiatric inpatients. But, to date, studies specifically focused on the impact of pain in patient populations in psychiatric hospitals are few. More recently, a review of the literature highlights the difficulties of evaluation of pain in populations of psychiatric patients but also the complex interrelationships between painful symptoms and psychiatric diseases. The first national survey conducted among 172 health which evaluate pain and its management in the field of psychiatry concluded on the need to develop research in this area.
Read the detailed description
Pain in all the populations remains a major public health issue. Patients with mental illness consult less their general practitioners while they have an increased risk of physical disease. In addition, they have a net reduction in life expectancy due to their mental illness, living conditions and drug treatments.
In this particular population, doctors faces especially difficulties assessment and treatment of pain. Indeed, there is for example in some of these patients difficulties to express that pain.
These painful events make more complex the care of hospitalized patients (eg interrelationship between pain complaints and psychiatric symptoms) and seem to lengthen their hospital stay. This is not without consequences as long as hospitalizations represent an obstacle to the patients psychosocial rehabilitation (installation of daytime activities, project work rehabilitation, development of social network ...) and impair their quality of life.
And for the patients with psychiatric disorders some points can be noticed :
- An increased risk of physical disease
- Warning signs like pain poorly known and poorly evaluated ... and poorly supported
- The presence of the pain seems to lengthen the hospital stay
- An extension of the hospital stay, which represent an obstacle to the psychosocial rehabilitation This research project is to test if the presence of a painful complaint among psychiatric inpatients is associated lengthening of the hospitalization duration.
The secondary objectives of this study are:
- To measure the prevalence of painful complaint in this specific population,
- To examine the evolution of pain during hospitalization.
- Identify factors influencing the relationship between pain and length of stay
- To identify if the intensity of the psychiatric illness is associated with pain intensity measured
Confirmation of these objectives would lead to a better understanding of the factors influencing psychiatric hospital stays and thus more efficient management of health resources.
In addition, the present study will well identify and implement standardized assessments of pain for these patients.
For these patients the interest is important because they can be in great difficulty to express a painful complaint. These people have often difficulties to communicate, and live in a sometimes precarious environment and severity of disorders reduce their access to care.
This approach is part of a comprehensive approach taking account of the psychiatric and somatic disorders in a very vulnerable population.
- Conditions
- Pain
- Being tested
- Pain scales
- Keywords
- Pain, Psychiatric disorders
- Medical subject headings
- Pain, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain scalesOther
- Visual analogic scale of pain
- Pain behaviour scale
- Short-FormHealth Survey (SF-36)
- Clinical Global impression
- Mini International Neuropsychiatric Interview (MINI)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with psychiatric disorders will be assessed using five evaluation of pain scales :
* Visual analogic scale pain
* Pain behaviour scale
* Short-FormHealth Survey (SF-36)
* Global Clinical Impression (GCI) for severity and improvement
* Mini International Neuropsychiatric Interview (MINI) Receives: Other: Pain scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of pain on hospitalization stay evaluated with pain visual analogic scale
Multivariate regression analysis
Measured: Day 1
Influence of pain on hospitalization stay evaluated with pain visual analogic scale
Multivariate regression analysis
Measured: Day 7
Influence of pain on hospitalization stay evaluated with pain visual analogic scale
Multivariate regression analysis
Measured: 2 days before patient end of hospitalization
Secondary outcomes (11)
Evaluation of pain in psychiatric population with visual analogic scale of pain
Measured: Day 1
Evaluation of pain in psychiatric population with visual analogic scale of pain
Measured: Day 7
Evaluation of pain in psychiatric population with visual analogic scale of pain
Measured: 2 days before patient end of hospitalization
Evaluation of pain intensity impact on Mini International Neuropsychiatric Interview score
Measured: Day 1
Evaluation of pain intensity impact on Mini International Neuropsychiatric Interview score
Measured: 2 days before the patient end of hospitalization
Evaluation of gender impact on pain intensity using visual analogic scale of pain
Measured: Day 1
Evaluation of gender impact on pain intensity using visual analogic scale of pain
Measured: 2 days before the patient end of hospitalization
Evaluation of age impact on pain intensity using visual analogic scale of pain
Measured: Day 1
Evaluation of age impact on pain intensity using visual analogic scale of pain
Measured: 2 days before the patient end of hospitalization
Evaluation of Mini International Neuropsychiatric Interview score impact on hospitalization stay
Measured: Day 1
Evaluation of Mini International Neuropsychiatric Interview score impact on hospitalization stay
Measured: 2 days before the patient end of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionJul 2015
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 Hospital, ToulouseThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent SCHMITT, PHD, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822430
- Sponsor's protocol ID
- RC31-13-7017
- Acronym
- D-PSY
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain in Psychiatry : Impact on Length of Hospital Stays
- ClinicalTrials.gov ID
- NCT02822430
- Acronym / sponsor ID
- D-PSY / RC31-13-7017
- Conditions
- Pain
- Keywords
- Pain, Psychiatric disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Jul 2016 (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.
For several decades, authors are interested in the existence and meaning of painful symptoms in a population of psychiatric inpatients. But, to date, studies specifically focused on the impact of pain in patient populations in psychiatric hospitals are few. More recently, a review of the literature highlights the difficulties of evaluation of pain in populations of psychiatric patients but also the complex interrelationships between painful symptoms and psychiatric diseases. The first national survey conducted among 172 health which evaluate pain and its management in the field of psychiatry concluded on the need to develop research in this area.
Detailed description
Pain in all the populations remains a major public health issue. Patients with mental illness consult less their general practitioners while they have an increased risk of physical disease. In addition, they have a net reduction in life expectancy due to their mental illness, living conditions and drug treatments.
In this particular population, doctors faces especially difficulties assessment and treatment of pain. Indeed, there is for example in some of these patients difficulties to express that pain.
These painful events make more complex the care of hospitalized patients (eg interrelationship between pain complaints and psychiatric symptoms) and seem to lengthen their hospital stay. This is not without consequences as long as hospitalizations represent an obstacle to the patients psychosocial rehabilitation (installation of daytime activities, project work rehabilitation, development of social network ...) and impair their quality of life.
And for the patients with psychiatric disorders some points can be noticed :
- An increased risk of physical disease
- Warning signs like pain poorly known and poorly evaluated ... and poorly supported
- The presence of the pain seems to lengthen the hospital stay
- An extension of the hospital stay, which represent an obstacle to the psychosocial rehabilitation This research project is to test if the presence of a painful complaint among psychiatric inpatients is associated lengthening of the hospitalization duration.
The secondary objectives of this study are:
- To measure the prevalence of painful complaint in this specific population,
- To examine the evolution of pain during hospitalization.
- Identify factors influencing the relationship between pain and length of stay
- To identify if the intensity of the psychiatric illness is associated with pain intensity measured
Confirmation of these objectives would lead to a better understanding of the factors influencing psychiatric hospital stays and thus more efficient management of health resources.
In addition, the present study will well identify and implement standardized assessments of pain for these patients.
For these patients the interest is important because they can be in great difficulty to express a painful complaint. These people have often difficulties to communicate, and live in a sometimes precarious environment and severity of disorders reduce their access to care.
This approach is part of a comprehensive approach taking account of the psychiatric and somatic disorders in a very vulnerable population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Pain scalesPatients with psychiatric disorders will be assessed using five evaluation of pain scales : * Visual analogic scale pain * Pain behaviour scale * Short-FormHealth Survey (SF-36) * Global Clinical Impression (GCI) for severity and improvement * Mini International Neuropsychiatric Interview (MINI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with psychiatric disorders
Key inclusion criteria (3 listed)
- Patient eighteen years old
- Patient hospitalized in psychiatric service at Toulouse University Hospital
- Informed consent signed
Key exclusion criteria (1 listed)
- Patient treated with maintenance sismotherapy
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 |
|---|---|---|
| Pain scales* Visual analogic scale of pain * Pain behaviour scale * Short-FormHealth Survey (SF-36) * Clinical Global impression * Mini International Neuropsychiatric Interview (MINI) | Other | Patients |
Primary outcome
Influence of pain on hospitalization stay evaluated with pain visual analogic scale
Time frame: Day 1
Multivariate regression analysis
Influence of pain on hospitalization stay evaluated with pain visual analogic scale
Time frame: Day 7
Multivariate regression analysis
Influence of pain on hospitalization stay evaluated with pain visual analogic scale
Time frame: 2 days before patient end of hospitalization
Multivariate regression analysis
11 secondary outcomes
Evaluation of pain in psychiatric population with visual analogic scale of pain
Time frame: Day 1
Evaluation of pain in psychiatric population with visual analogic scale of pain
Time frame: Day 7
Evaluation of pain in psychiatric population with visual analogic scale of pain
Time frame: 2 days before patient end of hospitalization
Evaluation of pain intensity impact on Mini International Neuropsychiatric Interview score
Time frame: Day 1
Evaluation of pain intensity impact on Mini International Neuropsychiatric Interview score
Time frame: 2 days before the patient end of hospitalization
Evaluation of gender impact on pain intensity using visual analogic scale of pain
Time frame: Day 1
Evaluation of gender impact on pain intensity using visual analogic scale of pain
Time frame: 2 days before the patient end of hospitalization
Evaluation of age impact on pain intensity using visual analogic scale of pain
Time frame: Day 1
Evaluation of age impact on pain intensity using visual analogic scale of pain
Time frame: 2 days before the patient end of hospitalization
Evaluation of Mini International Neuropsychiatric Interview score impact on hospitalization stay
Time frame: Day 1
Evaluation of Mini International Neuropsychiatric Interview score impact on hospitalization stay
Time frame: 2 days before the patient end of hospitalization
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 4 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Laurent SCHMITT, PHD, MD principal investigator
University Hospital, Toulouse
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 Hospital, Toulouse at 1 site in France.
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 3 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 4 Jul 2016. 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 France. 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?
Influence of pain on hospitalization stay evaluated with pain visual analogic scale (time frame: Day 1). The study lists 3 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 4 Jul 2016.