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

NCT04898998 | Completed DMC

• 1 other identifier: 201901244A3C501
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

postoperative thirty, postoperative recovery room, complain

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 30 minutes

Study Arms (2)

TENS to alleviate the effect of thirsty after surgery

EXPERIMENTAL

Transcutaneous electrical nerve stimulation (TENS) on experimental group 20 mins to treatment postoperative thirsty.

Device: Transcutaneous electrical nerve stimulation (TENS)

Routine care to alleviate the effect of xerostomia (dry mouth) after surgery

PLACEBO COMPARATOR

routine care

Other: routine care

Interventions

Transcutaneous electrical nerve stimulation (TENS) DEVICE

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).

TENS to alleviate the effect of thirsty after surgery

routine care OTHER

routine care

Routine care to alleviate the effect of xerostomia (dry mouth) after surgery

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnancy, epilepsy, unconscious

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Hsiu-Ling Yang

Taoyuan District, Fuxing St., Guishan Dist, 333, Taiwan

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: February 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)