Postoperative ComplicationsNCT04898998
TENS to Alleviate the Effect of Thirty After Surgery Xerostomia (Dry Mouth) After Surgery
A study testing Transcutaneous electrical nerve stimulation (TENS) and routine care in people with Postoperative Complications, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS) and routine care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anesthesiology (ASA) physical status I-ΙII, elective abdominal surgery, >20 years old
Who cannot join
- pregnancy, epilepsy, unconscious
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Complications
- Being tested
- Transcutaneous electrical nerve stimulation (TENS), routine care
- Keywords
- postoperative thirty, postoperative recovery room, complain
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
routine careOther
routine care
| Study group | Role | What they receive |
|---|---|---|
| TENS to alleviate the effect of thirsty after surgery | Experimental | Transcutaneous electrical nerve stimulation (TENS) on experimental group 20 mins to treatment postoperative thirsty. Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
| Routine care to alleviate the effect of xerostomia (dry mouth) after surgery | Placebo comparator | routine care Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Feb 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiu-Ling Yang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898998
- Sponsor's protocol ID
- 201901244A3C501
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENS to Alleviate the Effect of Xerostomia (Dry Mouth) After Surgery
- ClinicalTrials.gov ID
- NCT04898998
- Acronym / sponsor ID
- 201901244A3C501
- Conditions
- Postoperative Complications
- Keywords
- postoperative thirty, postoperative recovery room, complain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS to alleviate the effect of thirsty after surgery | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)Transcutaneous electrical nerve stimulation (TENS) on experimental group 20 mins to treatment postoperative thirsty. |
| Routine care to alleviate the effect of xerostomia (dry mouth) after surgery | Placebo comparator | Other: routine careroutine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesiology (ASA) physical status I-ΙII, elective abdominal surgery, >20 years old
Key exclusion criteria (1 listed)
- pregnancy, epilepsy, unconscious
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS)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). | Device | TENS to alleviate the effect of thirsty after surgery |
| routine careroutine care | Other | Routine care to alleviate the effect of xerostomia (dry mouth) after surgery |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) and routine care in people with Postoperative Complications, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intModified Schirmer tear strip Test measured intensity of thirst (time frame: up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.