- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02857647
The Effects of an Information Video on Anxiety and Bariatric Surgery Knowledge Among Bariatric Surgery Candidates
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Only few studies have investigated anxiety level, bariatric surgery and nutrition knowledge and weight loss expectations prior to bariatric surgery. No studies have been published on how preparation lectures prior to bariatric surgery impact on anxiety level and on patients' knowledge. A better preparation process prior to the bariatric surgery may have an impact on higher success rates of bariatric surgeries.
Our study is an interventional prospective study on 200 bariatric surgery candidates from the Assuta Medical Center (AMC). The first 100 patients will be assigned to the control group and the later 100 patients will be assigned to the experimental group. All the participants will receive standard care, and only those participants who will assigned to the experimental group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the surgery date. The videotaped lecture will include information and guidelines of bariatric surgery preparation. Topics includes: types of surgeries, preparation to the hospitalization process and to the surgery (e.g. what to expect, personal equipment needs, description of the surgery admission process, etc.), dietary guidelines pre- and post-surgery (e.g. low carb diet 2-3 week prior to the surgery, post-surgery diet progression, techniques of eating and drinking, recommended dietary supplements), recommendation and tips for long term surgery success (e.g. definition of weight loss expectations, physiological, nutritional and life-style strategies for long-term weight loss). All participants will complete Bariatric surgery knowledge questionnaire and The state-trait anxiety inventory (STAI) questionnaire at the bariatric committee and once again at the pre-surgery clinic which take place 1-10 days pre-surgery. In addition, 20 participants be recruited to a pilot study for the validation of the Bariatric surgery knowledge questionnaire.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Pre-surgery: 18 years old or older, BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities and approval of the AMC committee to undergo bariatric surgery.
- Surgery types: laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB) and Single-anastomosis gastric bypass (SAGB)
- Surgery will take place at Assuta medical center.
- Reading and speaking Hebrew.
Exclusion Criteria:
- Previous bariatric surgery.
- Surgery types: laparoscopic adjustable gastric band (LAGB) or biliopancreatic diversion with duodenal switch (BPD-DS)
- Less than 2 weeks between bariatric committee and surgery date
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: The experimental group
Participants who will assigned to the experimental group will be asked to watch an information video of 30 minutes 1-2 weeks prior to the surgery date. n=100. |
Participants who will assigned to the experimental group will be asked to watch a 30 minutes videotaped lecture 1-2 weeks prior to the surgery date.
Topics includes: types of surgeries, preparation to the hospitalization process and to the surgery (e.g.
what to expect, personal equipment needs, description of the surgery admission process, etc.), dietary guidelines pre- and post-surgery (e.g.
low carb diet 2-3 week prior to the surgery, post-surgery diet progression, techniques of eating and drinking, recommended dietary supplements), recommendation and tips for long term surgery success (e.g.
definition of weight loss expectations, physiological, nutritional and life-style strategies for long-term weight loss).
|
|
Nessun intervento: The control group
Participants who will assigned to the control group will receive standard care and will not asked to watch a videotaped lecture prior to the surgery. n=100. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Anxiety
Lasso di tempo: pre-surgery
|
Pre-surgery anxiety level will be measured by the state-trait anxiety inventory (STAI) questionnaire.
|
pre-surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Bariatric surgery and nutrition knowledge
Lasso di tempo: pre-surgery
|
Bariatric surgery and nutrition knowledge will be measured by a questionnaire written by investigators.
|
pre-surgery
|
|
Weight loss expectation
Lasso di tempo: pre-surgery
|
pre-surgery
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 0041-16
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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