NCT06077188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2024

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

October 5, 2023

Last Update Submit

February 27, 2025

Conditions

Acute PancreatitisThirst

Keywords

Acute PancreatitisThirstnousevomiting

Outcome Measures

Primary Outcomes (1)

  • Thirst Severity -Visual Analog Scale

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

    Apply in the morning of the 1st day after application

Secondary Outcomes (2)

  • Rhodes Nausea, Vomiting and Retching Index

    Apply in the morning of the 1st day after application

  • Rhodes Nausea, Vomiting and Retching Index (

    Apply in the morning of the 1st day after application

Study Arms (2)

intervention group

EXPERIMENTAL
Other: Gum group

Control group

NO INTERVENTION

Interventions

Gum groupOTHER

Group chewing gum with xylitol

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Those with diabetes,
  • Does not like chewing gum,
  • Receiving radiotherapy or chemotherapy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Hospital

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 23167908BACKGROUND

  • 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.

    PMID: 25888327BACKGROUND

  • 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.

    PMID: 26486285BACKGROUND

  • 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.

    PMID: 28210437BACKGROUND

MeSH Terms

Conditions

PancreatitisVomiting

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching staff

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

March 15, 2024

Primary Completion

May 1, 2024

Study Completion

June 29, 2024

Last Updated

March 3, 2025

Record last verified: 2024-02

Locations

TU(1)