Pain Clinical Trial
Official title:
Improvement of a Physically Active Lifestyle in Orthopedic and Cardiologic Rehabilitation Patients With an Expert System
To help rehabilitation patients to adopt and maintain a physically active lifestyle, it is imperative to increase self-management competencies. Aim of this research project is to evaluate an evidence- and theory-based computerized expert system in comparison to a well established standard program and a questionnaire-only group. Rehabilitation patients will be treated psychologically and followed up over 18 months. The computerized expert system is expected to help patients better than the standard program. Both interventions are hypothesized to improve self-management competencies over and above the rehabilitation treatment (i.e., questionnaire-only group).
An experimental study with three groups is planned over a time period of 18 months. Patients
in the intervention group receive an interactive, computerized expert system (Intervention
Group, IG). Patients in the Active Control Group (ACG) get an interactive computerized
standard program. This standard program has already been proven to be effective but which
does not tailor treatment components to the individual needs of the patients. Patients in
the Passive Control Group (PCG) are asked to answer the questionnaires only. Rehabilitation
patients (N = 1000) will be recruited in three rehabilitation clinics and followed up over
six measurement points: t1 and t2 with computer interventions during their rehabilitation
stay; t3 and t4 with booster-sessions via telephone (6 weeks and 6 months after admission
from rehabilitation). Furthermore, patients will be contacted at t5 per mail with
motivational material (12 months after admission) and at t6 again per mail (only
questionnaire, 18 months after admission).
The hypotheses are: In comparison to the PCG, both the IG and the ACG are expected to have a
higher motivation, to adopt a healthy lifestyle, to perform more health behavior and to be
less likely to relapse into previous unhealthy routines. Also, IG and ACG will be healthier
as well as they will report more quality of life and rehabilitation satisfaction. In
comparison to ACG, the IG is hypothesized to be more effective than the ACG regarding
motivation, behavior and social-cognitive predictors of behavior. Moreover, the
interventions (ACG and IG) are supposed to be equally effective for cardiac and orthopedic,
as well as out-patient and stationary treated rehabilitation patients. After successful
evaluation and some adoptions the intervention will be implemented as a self-help program in
all eligible rehabilitation clinics and in the internet.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
| Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
| Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
| Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
| Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
| Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
| Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
| Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
| Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
| Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
| Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
| Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
| Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
| Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
| Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
| Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
| Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
| Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
| Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|