Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery

NCT04657913 | Unknown

• 1 other identifier: Ankara Medipol University
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of spray use on dry mouth and thirst of patients who had undergone major abdominal surgery. The methods used to alleviate the thirst and dry mouth experienced by patients undergoing major abdominal surgery are limited. This research was conducted as a randomized controlled trial.

Conditions

Xerostomia; Thirst

Keywords

mouth dryness; thirst; saliva; oral health; major abdominal surgery; randomized controlled health

Outcome Measures

Primary Outcomes (4)

• mouth dryness severity

  Numbered between 0-10 0: no dry mouth 10: very severe dry mouth Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.

  Evaluation was made in the first 48 hours after surgery

• thirst severity

  Numbered between 0-10 0: no thirsty 10: very severe thirsty Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.

  Evaluation was made in the first 48 hours after surgery

• saliva PH

  To measure the pH value, the patient's saliva sample were taken and simple PH test sticks were used and the PH value were determined according to the color changes on the PH test stick.

  Evaluation was made in the first 48 hours after surgery

• oral condition

  The Oral Health Assessment Tool were used. As the score on the scale increases, the oral condition worsens.

  Evaluation was made in the first 48 hours after surgery

Secondary Outcomes (1)

• patient satisfaction assessed by the VAS

  It were evaluated at 48th hours postoperatively.

Study Arms (3)

cold water spray group

EXPERIMENTAL

application of cold water in the form of a spray to mouth of patients will be applied 2 times per hour, starting 2 hours after the end of the operation.

Other: cold water spray application

cold saline spray group

EXPERIMENTAL

application of cold 0.9% SF (saline) in the form of a spray to mouth of patients will be applied 2 times per hour, starting 2 hours after the end of the operation.

Other: cold saline spray application

control group

NO INTERVENTION

no intervention

Interventions

cold water spray application OTHER

It will be sprayed into the mouth of patients every hour.

Also known as: cold water spray

cold water spray group

cold saline spray application OTHER

It will be sprayed into the mouth of patients every hour.

Also known as: cold saline spray

cold saline spray group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who underwent major abdominal surgery under general anesthesia (due to lower and upper gastrointestinal tract malignancy)
• patients without oral and nasal disease
• patients who do not have vision, hearing, speech and understanding problems
• patients with American Society of Anesthesiologists (ASA) I and II scores
• patients over the age of 18

You may not qualify if:

• patients whose mouth and tongue mucosa integrity was degraded
• patients had a cognitive disorder
• patients had a neurological, renal, cardiac or pulmonary disorders that could affect the test results
• patients using psychoactive drugs

Sponsors & Collaborators

• Ankara Medipol University: lead

Study Sites (1)

Gulhane Education and Training Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Oztas M, Oztas B. Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):214-220. doi: 10.1016/j.jopan.2021.04.018. Epub 2022 Feb 10.

  PMID: 35153118 DERIVED

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Bediye Oztas, Phd

  Ankara Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: December 8, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: December 8, 2020

Record last verified: 2020-09

Locations

TU (1)