NCT03410589

Brief Summary

The purpose of this study is to evaluate quality of life, sleep and fadigue in patients with chronic pain using an Item-Response Theory methodology and also generating a Computer Adaptive Testing System

Trial Health

87
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

January 10, 2018

Last Update Submit

June 25, 2025

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (5)

  • sleep disorders

    score in Pittsburgh Sleep Quality

    Within 1 month before the study start

  • fatigue

    score of Multidimensional Fatigue Inventory

    Within 7 days before the study start

  • measurement quality of live

    measurement quality of live will be score the using SF-12

    Within 1 month before the study start

  • sleep disorders

    score Index and Insomnia Severity Index (ISI)

    Within 1 month before the study start

  • measurement quality of live

    measurement quality of live will be WHOQOL-bref

    Within 1 month before the study start

Study Arms (1)

Single arm

Other: Sinlge arm

Interventions

Sinlge armOTHER

application of scales for evaluation of sleep, fatigue and quality of life - Observational study

Single arm

Eligibility Criteria

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

Patients with chronic pain

You may qualify if:

  • be able to read Portuguese be able to write Portuguese being in treatment for chronic pain

You may not qualify if:

  • hearing impairment that impairs ability to respond to tests visual impairment that impairs ability to respond to tests physical impairment that impairs ability to respond to tests cognitive impairment that impairs ability to respond to tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das clinicas da FMUSP

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel C Andrade, PhD

    doctor and investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 25, 2018

Study Start

January 1, 2019

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations

BR(1)