Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance (HYPNOC)
9 augusti 2016 uppdaterad av: Claudia Spies, Charite University, Berlin, Germany
Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance. A Randomized-controlled Open Clinical Monocentric Interventional Study.
The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac or spinal column surgery.
A particular aim is to point out the effects on postoperative cognitive outcome.
Additional blood and urine tests are conducted (concerning cardiac stratum).
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
72
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Berlin, Tyskland, 13353
- Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients aged 18 years and older
- Patients scheduled for open heart surgery or spinal column surgery
- Offered patient information and written informed consent
- Mini Mental State > 23
- American Society of Anesthesiologists physical status classification system (ASA) 1-3
Exclusion Criteria:
- No informed consent
- Patients aged <18 years
- Patients living outside Berlin/Potsdam and surrounding area
- Less than 5 points in Stanford Scale of Hypnotic Susceptibility: Form C; German version (SHSS:C -Weitzenhoffer & Hilgard, 1962; Bongartz, 1999 a)in the screening/recruiting phase
- Lacking consent capability or accommodation in an institution due to an official or judicial order
- Emergency patients or ambulant patients
- Pregnancy and lactation
- Coworkers at Charité
- Lacking willingness to save and hand out data within the study
- Insufficient knowledge of the German language
- Participation in another trial according to the German Drug Law the week before inclusion (in the study) and the parallel participation in another trial according to the German Drug Law within the first 3 months after surgery
- Acute, severe psychic disease (acute psychotic disorder, severe drug dependency, withdrawal symptoms)
- Conditions which make a sufficient information and consequent consent impossible
- The patient is under juridical supervision
- acute risk of suicide
- dementia
- patients who suffer from insulin dependent Diabetes mellitus and who have been diagnosed with Diabetes mellitus within the last year
- patients who have suffered allergic shock in the past
- hardness of hearing, deafness, blindness
- cardiac function: ejection fraction (EF) < 30%
- Patients undergoing psychotherapeutic treatment
- Patients taking awareness-modulating drugs (antipsychotic drugs)
- Boozed/primed patients or patients under drug influence
- Patients having had an epileptic seizure within the last four weeks
- Patients suffering from productive cough
- Patients having a chronic low blood pressure (systolic <90mmHg)
- Allergies to any ingredient of the electrode fixing material (only for participants of sleep stage assessment)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Hypnotherapy
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Pre- (one session) and postoperative (two sessions) Hypnotherapy
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Inget ingripande: No Hypnotherapy
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Incidence of postoperative cognitive dysfunction at the time of discharge
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of postoperative cognitive dysfunction three months after surgery
Tidsram: three months after surgery
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three months after surgery
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Postoperative delirium
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Reduction in pre- and postoperative agitation and anxiety
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Reduction of pain
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Reduction of stress
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Reduction of holding time
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Reduction of hospital stay
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Reduction of Intensive Care Unit stay
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Readmission rate
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Emotional status
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
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on day 7 - 30 after surgery
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Functional status
Tidsram: on day 7 - 30 after surgery
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Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery)
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on day 7 - 30 after surgery
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Subjective evaluation of sleep quality
Tidsram: Before surgery
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Insomnia Severity Index (ISI)
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Before surgery
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Perioperative assessment of sleep stage
Tidsram: the night after surgery;the night before discharge; 3 months after surgery
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the night after surgery;the night before discharge; 3 months after surgery
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Additional blood and urine tests (concerning cardiac stratum)
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Claudia Spies, MD Prof., Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2012
Primärt slutförande (Faktisk)
1 april 2014
Avslutad studie (Faktisk)
1 juli 2016
Studieregistreringsdatum
Först inskickad
30 januari 2012
Först inskickad som uppfyllde QC-kriterierna
30 januari 2012
Första postat (Uppskatta)
1 februari 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 augusti 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HYPNOC
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .