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EFFECT OF CHEWING GUM ON CONTROLLING NAUSEA/VOMITING AND THIRST IN PATIENTS WITH ACUTE PANCREATITIS

Primary Purpose

Acute Pancreatitis, Thirst

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gum group
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pancreatitis focused on measuring Acute Pancreatitis, Thirst, nouse, vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Those diagnosed with acute pancreatitis, Without total dental prosthesis, Without salivary gland infection, Those who have not had salivary gland surgery, No difficulty in chewing, Not receiving oxygen therapy, Able to answer all questions and be communicativ Exclusion Criteria: Those with diabetes, Does not like chewing gum, Receiving radiotherapy or chemotherapy,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Thirst Severity -Visual Analog Scale
    Visual Analog Scale is a 10 cm long scale that evaluates the severity of thirst.

    Secondary Outcome Measures

    Rhodes Nausea, Vomiting and Retching Index
    It is an eight-item scale that measures the number and severity of patients' nausea, vomiting and retching in the last 24 hours.
    Rhodes Nausea, Vomiting and Retching Index (
    It is an eight-item scale that measures the number and severity of patients' nausea, vomiting and retching in the last 24 hours.

    Full Information

    First Posted
    October 5, 2023
    Last Updated
    October 11, 2023
    Sponsor
    TC Erciyes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06077188
    Brief Title
    EFFECT OF CHEWING GUM ON CONTROLLING NAUSEA/VOMITING AND THIRST IN PATIENTS WITH ACUTE PANCREATITIS
    Official Title
    Erciyes University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Nausea and vomiting are one of the most common symptoms in acute pancreatitis. In addition to pharmacological methods for nausea and vomiting, non-pharmacological methods can also be used. Among these, anticipatory nausea and vomiting can be prevented by behaviors aimed at distracting attention. This study will be conducted to evaluate the effect of chewing gum on the severity of nausea-vomiting and thirst in patients with acute pancreatitis. The study will be conducted with a total of 60 patients, 30 intervention and 30 control. Patients in the intervention group will chew xylitol gum five times a day for three days. The patients' thirst and nausea and vomiting conditions will be examined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pancreatitis, Thirst
    Keywords
    Acute Pancreatitis, Thirst, nouse, vomiting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Gum group
    Intervention Description
    Group chewing gum with xylitol
    Primary Outcome Measure Information:
    Title
    Thirst Severity -Visual Analog Scale
    Description
    Visual Analog Scale is a 10 cm long scale that evaluates the severity of thirst.
    Time Frame
    Apply in the morning of the 1st day after application
    Secondary Outcome Measure Information:
    Title
    Rhodes Nausea, Vomiting and Retching Index
    Description
    It is an eight-item scale that measures the number and severity of patients' nausea, vomiting and retching in the last 24 hours.
    Time Frame
    Apply in the morning of the 1st day after application
    Title
    Rhodes Nausea, Vomiting and Retching Index (
    Description
    It is an eight-item scale that measures the number and severity of patients' nausea, vomiting and retching in the last 24 hours.
    Time Frame
    Apply in the morning of the 1st day after application

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Those diagnosed with acute pancreatitis, Without total dental prosthesis, Without salivary gland infection, Those who have not had salivary gland surgery, No difficulty in chewing, Not receiving oxygen therapy, Able to answer all questions and be communicativ Exclusion Criteria: Those with diabetes, Does not like chewing gum, Receiving radiotherapy or chemotherapy,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ÖZLEM CEYHAN
    Phone
    +903520207 6666
    Ext
    28561
    Email
    ozlemg@erciyes.edu.tr

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23167908
    Citation
    Jensdottir T, Buchwald C, Nauntofte B, Hansen HS, Bardow A. Saliva in relation to dental erosion before and after radiotherapy. Acta Odontol Scand. 2013 May-Jul;71(3-4):1008-13. doi: 10.3109/00016357.2012.741704. Epub 2012 Nov 21.
    Results Reference
    background
    PubMed Identifier
    25888327
    Citation
    Oyetola EO, Owotade FJ, Agbelusi GA, Fatusi OA, Sanusi AA. Oral findings in chronic kidney disease: implications for management in developing countries. BMC Oral Health. 2015 Feb 20;15:24. doi: 10.1186/s12903-015-0004-z.
    Results Reference
    background
    PubMed Identifier
    26486285
    Citation
    Silva AC, Aprile LR, Dantas RO. EFFECT OF GUM CHEWING ON AIR SWALLOWING, SALIVA SWALLOWING AND BELCHING. Arq Gastroenterol. 2015 Jul-Sep;52(3):190-4. doi: 10.1590/S0004-28032015000300007.
    Results Reference
    background
    PubMed Identifier
    28210437
    Citation
    Honarmand M, Farhad-Mollashahi L, Nakhaee A, Sargolzaie F. Oral manifestation and salivary changes in renal patients undergoing hemodialysis. J Clin Exp Dent. 2017 Feb 1;9(2):e207-e210. doi: 10.4317/jced.53215. eCollection 2017 Feb.
    Results Reference
    background

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    EFFECT OF CHEWING GUM ON CONTROLLING NAUSEA/VOMITING AND THIRST IN PATIENTS WITH ACUTE PANCREATITIS

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