NCT02822430

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
Last Updated

July 4, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

June 21, 2016

Last Update Submit

June 29, 2016

Conditions

Keywords

PainPsychiatric disorders

Outcome Measures

Primary Outcomes (3)

  • Influence of pain on hospitalization stay evaluated with pain visual analogic scale

    Multivariate regression analysis

    Day 1

  • Influence of pain on hospitalization stay evaluated with pain visual analogic scale

    Multivariate regression analysis

    Day 7

  • Influence of pain on hospitalization stay evaluated with pain visual analogic scale

    Multivariate regression analysis

    2 days before patient end of hospitalization

Secondary Outcomes (11)

  • Evaluation of pain in psychiatric population with visual analogic scale of pain

    Day 1

  • Evaluation of pain in psychiatric population with visual analogic scale of pain

    Day 7

  • Evaluation of pain in psychiatric population with visual analogic scale of pain

    2 days before patient end of hospitalization

  • Evaluation of pain intensity impact on Mini International Neuropsychiatric Interview score

    Day 1

  • Evaluation of pain intensity impact on Mini International Neuropsychiatric Interview score

    2 days before the patient end of hospitalization

  • +6 more secondary outcomes

Study Arms (1)

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)

Other: Pain scales

Interventions

* Visual analogic scale of pain * Pain behaviour scale * Short-FormHealth Survey (SF-36) * Clinical Global impression * Mini International Neuropsychiatric Interview (MINI)

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with psychiatric disorders

You may qualify if:

  • Patient eighteen years old
  • Patient hospitalized in psychiatric service at Toulouse University Hospital
  • Informed consent signed

You may not qualify if:

  • Patient treated with maintenance sismotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Functionnal unit of psychiatry

Toulouse, 31000, France

Location

MeSH Terms

Conditions

PainMental Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laurent SCHMITT, PHD, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

July 4, 2016

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 4, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations