TENS to Alleviate the Effect of Thirty After Surgery Xerostomia (Dry Mouth) After Surgery

May 21, 2021 updated by: Hsiu-Ling Yang, Chang Gung Memorial Hospital

TENS to Alleviate the Effect of Xerostomia (Dry Mouth) After Surgery

Dry mouth of postoperative makes the patient feel thirst, and the pain of the lips is cracked. It will also make the sputum thick and sticky, making it difficult for the patient to cough by himself. Especially the elderly may have sputum accumulation and pneumonia. Dry mouth can easily change the pH value in the mouth, destroy the environment in the mouth, and increase the chance of oral mucosal lesions, ulcers and infections. The physical discomfort can lead to psychological effects such as anxiety, irritability, and irritability. The incidence of dry mouth was 88%, 6-8 hours after abdominal surgery. Although the incidence is high, compared with other complications after surgery (such as: pain, bleeding, etc.), dry mouth after surgery is less important, and is underestimated, unmeasured, unrecorded and untreated. Initiating the motivation of this study, it is hoped that through research to understand the relevant factors causing dry mouth after surgery, and using transcutaneous electrical nerve stimulation (TENS) to improve the symptoms of dry mouth after surgery. The first phase is to describe the relevant studies with the aim of understanding the relevant factors that contribute to dry mouth after surgery. This study will understand and pay attention to the post-operative dry mouth. It is hoped that through this study, the problem of dry mouth after surgery will be improved, and the comfort of the recovery period after surgery will be improved, so that patients can get better care and promote the quality of care.

Study Overview

Detailed Description

Introduction A postoperative thirst is one of the major complaints in the recovery room. The purpose of this experimental study was to compare the efficiency of reducing postoperative thirst by transcutaneous electrical nerve stimulation (TENS) and routine care.

Methods Surgical patients under general anesthesia were recruited from a medical center. Each patient was randomly assigned to the experimental group (TENS) or control group (routine care). Experimental group had 53 patients and control group had 52 patients fitted in the inclusion and exclusion criteria and completed data collection. The intensity of thirst was measured pretreatment, immediately after treatment and 30 minutes after treatment. All data were managed by SPSS for Windows (version 21.0). Descriptive and inferential statistics (Chi-square test, t-test, generalized estimating equation regression analysis) were performed to identify the relationships that were proposed.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Fuxing St., Guishan Dist
      • Taoyuan, Fuxing St., Guishan Dist, Taiwan, 333
        • Hsiu-Ling Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Anesthesiology (ASA) physical status I-ΙII, elective abdominal surgery, >20 years old

Exclusion Criteria:

  • pregnancy, epilepsy, unconscious

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TENS to alleviate the effect of thirsty after surgery
Transcutaneous electrical nerve stimulation (TENS) on experimental group 20 mins to treatment postoperative thirsty.
Surgical patients under general anesthesia were recruited from a medical center. Each patient was randomly assigned to the experimental group (TENS) or control group (routine care).
PLACEBO_COMPARATOR: Routine care to alleviate the effect of xerostomia (dry mouth) after surgery
routine care
routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intModified Schirmer tear strip Test measured intensity of thirst
Time Frame: up to 30 minutes
Change from Baseline intensity of thirst was measured pre-treatment, immediately after treatment and 30 minutes after treatment.
up to 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (ACTUAL)

May 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Complications

Clinical Trials on routine care

3
Subscribe