TENS to Alleviate the Effect of Thirty After Surgery Xerostomia (Dry Mouth) After Surgery
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation (TENS)
routine care
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring postoperative thirty, postoperative recovery room, complain
Eligibility Criteria
Inclusion Criteria:
- Anesthesiology (ASA) physical status I-ΙII, elective abdominal surgery, >20 years old
Exclusion Criteria:
- pregnancy, epilepsy, unconscious
Sites / Locations
- Hsiu-Ling Yang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TENS to alleviate the effect of thirsty after surgery
Routine care to alleviate the effect of xerostomia (dry mouth) after surgery
Arm Description
Transcutaneous electrical nerve stimulation (TENS) on experimental group 20 mins to treatment postoperative thirsty.
routine care
Outcomes
Primary Outcome Measures
The intModified Schirmer tear strip Test measured intensity of thirst
Change from Baseline intensity of thirst was measured pre-treatment, immediately after treatment and 30 minutes after treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT04898998
First Posted
May 19, 2021
Last Updated
May 21, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04898998
Brief Title
TENS to Alleviate the Effect of Thirty After Surgery Xerostomia (Dry Mouth) After Surgery
Official Title
TENS to Alleviate the Effect of Xerostomia (Dry Mouth) After Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
postoperative thirty, postoperative recovery room, complain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS to alleviate the effect of thirsty after surgery
Arm Type
Experimental
Arm Description
Transcutaneous electrical nerve stimulation (TENS) on experimental group 20 mins to treatment postoperative thirsty.
Arm Title
Routine care to alleviate the effect of xerostomia (dry mouth) after surgery
Arm Type
Placebo Comparator
Arm Description
routine care
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
routine care
Intervention Description
routine care
Primary Outcome Measure Information:
Title
The intModified Schirmer tear strip Test measured intensity of thirst
Description
Change from Baseline intensity of thirst was measured pre-treatment, immediately after treatment and 30 minutes after treatment.
Time Frame
up to 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anesthesiology (ASA) physical status I-ΙII, elective abdominal surgery, >20 years old
Exclusion Criteria:
pregnancy, epilepsy, unconscious
Facility Information:
Facility Name
Hsiu-Ling Yang
City
Taoyuan
State/Province
Fuxing St., Guishan Dist
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TENS to Alleviate the Effect of Thirty After Surgery Xerostomia (Dry Mouth) After Surgery
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