- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02615483
Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study will seek to reduce pre- and postoperative anxiety, depression and functional impairments using alternative cognitive and educative methods, targeting the underlying factors for development of anxiety and depression.
It is known that there is a rationale behind using Cognitive Behavioural Therapy (CBT) in order to reduce pre- and postoperatively anxiety and depression. The main assumption within CBT is that patients´ perceptions create their thoughts and beliefs, which influence their feelings and subsequently their behaviour. The features of WP in this study will seek in several ways to exceed this expected behaviour modification. The preliminary choices of features on the WP are made in order to prevent catastrophic images and thereby reduce anxiety and depression. The WP will offer patients non-catastrophic images through animated information mirroring the course of treatment, which will aim to influence their beliefs, feelings and their behaviour.
To examine the effect of the WP versus conventional information and course of rehabilitation, on patients' degree of anxiety and depression, a randomized controlled trial will be preformed. A total of 114 patients scheduled for elective instrumented LSF will be included and randomly assigned to the control group or to the intervention group receiving access to the WP.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Silkeborg, Danmark, 8600
- Centre og Elective Surgery, Regional Hospital Silkeborg
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients who are going to have a one-three level instrumented Lumbar Spinal Fusion
Exclusion Criteria:
- Age below 18, known psychiatric disorder, prior LSF, as the success rates of re-operations are found as low as 35%, inability to communicate in Danish and finally patients with no internet connection.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Web-based platform
Access to a web-based platform
|
The WP is based on a conducted literature review and results form a previous study conducted in the regional context of the study. Information on the WP is animated based on the current literature stating that educative animation video optimises patients' acquisition of knowledge. The intention is to offer the patients the advantages in gaining knowledge in familiar surroundings and at a pace matching their needs and wishes. The WP contains animated and written information mirroring the course of treatment, frequently asked questions and answers, it contains animated training support, a diary in order to keep track of training and development of pain and finally a social feature, a web-café. |
Ingen inngripen: Control
Conventional
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Anxiety and Depression
Tidsramme: 3 months after surgery
|
The change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)
|
3 months after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Functional outcome
Tidsramme: 3, 6,12 months after surgery
|
Oswestry Disability Index (ODI)
|
3, 6,12 months after surgery
|
Self-perceived health status
Tidsramme: 3, 6, 12 months after surgery
|
EQ-5D
|
3, 6, 12 months after surgery
|
Back and leg pain
Tidsramme: 3, 6, 12 months after surgery
|
Low Back Pain Rating Scale (LBPRS)
|
3, 6, 12 months after surgery
|
Anxiety and Depression
Tidsramme: 6, 12 months after surgery
|
HADS
|
6, 12 months after surgery
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Claus V. Nielsen, professor, Institute of Publich health, Aarhus University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 654902
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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