- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04898998
TENS to Alleviate the Effect of Thirty After Surgery Xerostomia (Dry Mouth) After Surgery
TENS to Alleviate the Effect of Xerostomia (Dry Mouth) After Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Fuxing St., Guishan Dist
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Taoyuan, Fuxing St., Guishan Dist, Taiwan, 333
- Hsiu-Ling Yang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Anesthesiology (ASA) physical status I-ΙII, elective abdominal surgery, >20 years old
Exclusion Criteria:
- pregnancy, epilepsy, unconscious
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201901244A3C501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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