- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07618559
The Food Network Effect
The Food Network Effect: A Study of Food Related Visual Stimuli and Postoperative Gastrointestinal Recovery
The goal of this clinical trial is to learn if exposure to food related visual stimuli during the postoperative period can improve gastrointestinal recovery after abdominal surgery in adult patients.The main questions it aims to answer are:
- Does structured exposure to food related television programming shorten the time to return of bowel function after surgery?
- Does exposure to food related visual stimuli reduce postoperative ileus and improve recovery related outcomes such as hospital length of stay, appetite, patient satisfaction, and medication use?
Researchers will compare patients receiving structured food related programming during meal periods with patients receiving standard postoperative care to see if food related visual stimulation improves postoperative gastrointestinal recovery.
Participants will:
- Be randomly assigned to either a food-programming group or a standard care group
- Watch food-related television programming for at least 15 minutes during scheduled meal-time periods if assigned to the intervention group
- Have daily collection of routine postoperative information, including bowel function, medication use, and diet progression
- Complete brief optional questions regarding appetite and satisfaction during hospitalization
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Postoperative ileus and delayed return of gastrointestinal function remain common complications following abdominal surgery and contribute to patient discomfort, prolonged hospitalization, and increased healthcare utilization. Despite advances in perioperative management and implementation of enhanced recovery protocols, impaired bowel function after surgery continues to affect recovery. Early enteral stimulation has been associated with improved gastrointestinal recovery; however, many patients experience appetite suppression or difficulty tolerating oral intake during the immediate postoperative period.
Digestive activity is influenced by the cephalic phase response, a physiologic process in which sensory cues associated with food can activate neural pathways involved in digestion prior to food consumption. Visual food cues have been shown to affect appetite and physiologic responses related to feeding behavior, suggesting a potential mechanism through which noninvasive sensory stimulation could influence postoperative gastrointestinal recovery.
This study evaluates a structured behavioral intervention using food-related television programming during peri-meal periods as an adjunct to routine postoperative care. Participants will be prospectively randomized to receive either scheduled exposure to food-related visual stimuli or standard postoperative care. The intervention is designed to provide a simple, low-cost, non-pharmacologic strategy that can be implemented using existing hospital resources without altering routine clinical management.
The findings from this study may provide insight into whether sensory stimulation through visual food exposure can enhance postoperative recovery and serve as a scalable adjunct to current perioperative care practices
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Casey M Morehouse, DO
- Numer telefonu: 8034130578
- E-mail: cmmorehouse@gmail.com
Lokalizacje studiów
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South Carolina
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Columbia, South Carolina, Stany Zjednoczone, 29203
- Prisma Health Midlands
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Kontakt:
- Casey Morehouse, DO
- Numer telefonu: 8034130578
- E-mail: cmmorehouse@gmail.com
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Kontakt:
- Dominick Ricci, DO
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adult patients aged ≥18 years
- Undergoing abdominal surgery (including general, colorectal, trauma, or surgical oncology procedures) requiring inpatient post operative admission
- Able to participate in the intervention, including engaging with television based stimuli
- Able to follow simple instructions in the postoperative period
Exclusion Criteria:
- Critical illness requiring ICU-level care beyond the immediate postoperative period
- Mechanical ventilation (intubated patients)
- Requirement for high-level non-invasive ventilation (BiPAP for respiratory failure)
- Hemodynamic instability requiring vasopressor support
- Life support measures, including continuous renal replacement therapy (CRRT) or ECMO
- Altered mental status impairing participation (delirium requiring restraints)
- Glasgow Coma Scale (GCS) < 13 or inability to follow commands
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Food Related TV
Participants randomized to the intervention arm will receive standard postoperative care in addition to a structured behavioral intervention consisting of exposure to food-related visual stimuli during defined peri-meal periods throughout their postoperative hospitalization. Participants will be asked to watch food related television programming (e.g., cooking, baking, or food-centered shows) for a minimum of 15 minutes during each designated meal window: breakfast (7:00-9:00 AM), lunch (12:00-2:00 PM), and dinner (5:00-7:00 PM). Programming will be delivered using existing in-room hospital television resources and will not alter routine clinical care or dietary management. Compliance with the intervention will be monitored through participant self-report and periodic study team check-ins. Participants will continue all standard postoperative management according to routine clinical practice |
This intervention consists of a structured, non-pharmacologic behavioral exposure to food related visual stimuli delivered during predefined peri-meal periods throughout the postoperative hospitalization. Participants will view food centered television programming (e.g., cooking, baking, or food preparation shows) for a minimum of 15 minutes during each designated meal window: breakfast (7:00-9:00 AM), lunch (12:00-2:00 PM), and dinner (5:00-7:00 PM). Unlike standard television viewing or unrestricted media use, the intervention uses scheduled exposure to food-specific visual content intended to provide cephalic phase sensory stimulation during times corresponding with routine eating periods. The intervention is delivered using existing hospital television resources and does not involve medications, dietary modification, invasive procedures, or additional medical devices. Adherence will be assessed through participant self-report and periodic study team monitoring. |
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Brak interwencji: Non-modified postoperative recovery
Participants randomized to the no-intervention (control) arm will receive standard postoperative care according to routine clinical practice without structured exposure to food-related visual stimuli.
Participants may watch television at their discretion during hospitalization; however, they will not receive prompts, assigned programming, or scheduled meal-time viewing instructions.
No restrictions will be placed on normal television use or activities during recovery.
All other perioperative and postoperative care will remain unchanged and will be managed according to standard clinical protocols
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Incidence of postoperative ileus
Ramy czasowe: Until hospital discharge, can vary from 2-10 days
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Until hospital discharge, can vary from 2-10 days
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Return of bowel function
Ramy czasowe: from enrollment to the end of admission, can vary from 2-10 days
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measured by time to first flatus and/or time to first bowel movement;
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from enrollment to the end of admission, can vary from 2-10 days
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Współpracownicy i badacze
Sponsor
Współpracownicy
Publikacje i pomocne linki
Publikacje ogólne
- Wagner M, Probst P, Haselbeck-Kobler M, Brandenburg JM, Kalkum E, Storzinger D, Kessler J, Simon JJ, Friederich HC, Angelescu M, Billeter AT, Hackert T, Muller-Stich BP, Buchler MW. The Problem of Appetite Loss After Major Abdominal Surgery: A Systematic Review. Ann Surg. 2022 Aug 1;276(2):256-269. doi: 10.1097/SLA.0000000000005379. Epub 2022 Jan 27.
- Vather R, O'Grady G, Bissett IP, Dinning PG. Postoperative ileus: mechanisms and future directions for research. Clin Exp Pharmacol Physiol. 2014 May;41(5):358-70. doi: 10.1111/1440-1681.12220.
- Garg D, Smith E, Attuquayefio T. Watching Television While Eating Increases Food Intake: A Systematic Review and Meta-Analysis of Experimental Studies. Nutrients. 2025 Jan 2;17(1):166. doi: 10.3390/nu17010166.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2442405-1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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