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XerostomiaNCT04657913

Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery

A study testing cold water spray application and cold saline spray application in people with Xerostomia and Thirst, run by Ankara Medipol University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine the effects of spray use on dry mouth and thirst of patients who had undergone major abdominal surgery. The methods used to alleviate the thirst and dry mouth experienced by patients undergoing major abdominal surgery are limited. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Xerostomia, Thirst
What is being tested?
cold water spray application and cold saline spray application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2020to 31 Jan 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients who underwent major abdominal surgery under general anesthesia (due to lower and upper gastrointestinal tract malignancy)
  • patients without oral and nasal disease
  • patients who do not have vision, hearing, speech and understanding problems
  • patients with American Society of Anesthesiologists (ASA) I and II scores
  • patients over the age of 18

Who cannot join

  • patients whose mouth and tongue mucosa integrity was degraded
  • patients had a cognitive disorder
  • patients had a neurological, renal, cardiac or pulmonary disorders that could affect the test results
  • patients using psychoactive drugs

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gulhane Education and Training Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery: A Randomized Controlled Study

The purpose of this study is to determine the effects of spray use on dry mouth and thirst of patients who had undergone major abdominal surgery. The methods used to alleviate the thirst and dry mouth experienced by patients undergoing major abdominal surgery are limited. This research was conducted as a randomized controlled trial.

Read the detailed description

The study sample includes patients who had undergone major abdominal surgery induced by upper or lower gastrointestinal system malignancies. The patients who met the inclusion criteria were informed about the purpose of the study and were invited to the study. Those who accepted to participate in the study were included in the study.

Patients who had undergone major abdominal surgery with general anesthesia (induced by upper or lower gastrointestinal system malignancies), who do not have any oral and nasal diseases, who do not have visual, hearing, speech and understanding problems, who were in the American Society of Anesthesiologists (ASA) I and II grades, who were aged 18 or over and agreed to participate in the study were included.

Patients whose mouth and tongue mucosa integrity was degraded, who had a cognitive disorder, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results, or who use psychoactive drugs were excluded.

The standard anesthesia protocol was implemented to all patients suitable for the study. In the postoperative period, the standard rational dose antibiotic therapy (1st generation cephalosporin + metronidazole), metoclopramide HCL, NSAIDs, LMWH, N-acetylcysteine (NAC), H2-receptor blockers (ranitidine HCL), pethidine HCL 50 mg/ml, when required, and maintenance fluid therapy (Combination of normal saline, lactated Ringer's and Dextrose) by their weight were administered to the patients.

First Control Group: No intervention was performed on the patients in the control group. To prevent ethical violations, patients received routine clinical practice (a small amount of water was administered orally, using a syringe).

Second Intervention Group: Cold water kept at +40 C in the refrigerator was added into 50cc spray-head bottles and administered to patients orally in the postoperative phase, by spraying twice hourly.

Third intervention Group: Cold normal saline (0.9% NaCl) kept at +40 C in the refrigerator was added into 50cc spray-head bottles and administered to patients orally in the postoperative phase, by spraying twice hourly.

No intervention was performed on patients from midnight thru 06:00 AM, in order not to disturb the circadian rhythms of all patients.

Considering surgery end time and circadian rhythms of patients, the data of the patients were recorded at the post-operative 4, 8, 20, 24, 36, 40th hours. The flow chart of the study is shown in Figure 1. In the cold water and cold normal saline applications, 50cc glass bottles, plastic spray head, and cover were used. New material was used for each patient.

Preoperative measurements: Patients' data such as age, gender, comorbid diseases, ASA (American Society of Anesthesiologists) grade, diagnosis, preoperative thirst intensity, preoperative mouth dryness intensity, preoperative oral health condition were recorded.

Outcome measurements Postoperative evaluations were made after the interventions. Intensity of Thirst: VAS with a range of 0-10 points (0: mild, 10 very severe) was used while the thirsty severity of all patients were evaluated.

Intensity of Mouth Dryness: VAS with a range of 0-10 points (0: never experiencing mouth dryness, 10: experiencing very intense mouth dryness) was used while the mouth dryness severity of all patients were evaluated.

Oral Health Condition: To assess patients' oral health condition, the Oral Health Assessment Tool (OHAT) was used. The first four items of the scale that assess lips, tongue, gums and tissue, and saliva were used. The lowest score to be obtained from the scale is 0, while the highest score is 8 (0=healthy; 1=changes; 2=unhealthy). A higher OHAT score indicates a poor oral condition.

Saliva PH: To measure the PH of saliva, the patient's saliva sample in a sterile container was assessed using PH test strips.

Patient Satisfaction: To evaluate patient satisfaction, overall satisfaction was scored using a 10-point numerical rating scale (NRS) from 0 (complete dissatisfaction) to 10 (complete satisfaction).

At the postoperative 4th hour, the severity of thirst and dry mouth, oral health status and saliva PH values were evaluated in terms of differences between the groups.

At the postoperative 8th hour, the severity of thirst and dry mouth, oral health status and saliva PH values were evaluated in terms of differences between the groups.

At the postoperative 20,24,36 and 40th hour, the severity of thirst and dry mouth, oral health status and saliva PH values were evaluated in terms of differences between the groups.

Conditions
Xerostomia, Thirst
Being tested
cold water spray application, cold saline spray application
Keywords
mouth dryness, thirst, saliva, oral health, major abdominal surgery, randomized controlled health
Medical subject headings
Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cold water spray applicationOther

    Also called cold water spray

    It will be sprayed into the mouth of patients every hour.

  • cold saline spray applicationOther

    Also called cold saline spray

    It will be sprayed into the mouth of patients every hour.

Study groups in NCT04657913
Study groupRoleWhat they receive
cold water spray groupExperimentalapplication of cold water in the form of a spray to mouth of patients will be applied 2 times per hour, starting 2 hours after the end of the operation.
Receives: Other: cold water spray application
cold saline spray groupExperimentalapplication of cold 0.9% SF (saline) in the form of a spray to mouth of patients will be applied 2 times per hour, starting 2 hours after the end of the operation.
Receives: Other: cold saline spray application
control groupNo interventionno intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mouth dryness severity

    Numbered between 0-10 0: no dry mouth 10: very severe dry mouth Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.

    Measured: Evaluation was made in the first 48 hours after surgery

  2. thirst severity

    Numbered between 0-10 0: no thirsty 10: very severe thirsty Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.

    Measured: Evaluation was made in the first 48 hours after surgery

  3. saliva PH

    To measure the pH value, the patient's saliva sample were taken and simple PH test sticks were used and the PH value were determined according to the color changes on the PH test stick.

    Measured: Evaluation was made in the first 48 hours after surgery

  4. oral condition

    The Oral Health Assessment Tool were used. As the score on the scale increases, the oral condition worsens.

    Measured: Evaluation was made in the first 48 hours after surgery

Secondary outcomes (1)
  1. patient satisfaction assessed by the VAS

    VAS will be used, numbered between 0-10, 0: not satisfied at all, 10: very satisfied.

    Measured: It were evaluated at 48th hours postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2020
  2. Study start1 Feb 2020
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Jan 2021 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04657913
Sponsor's protocol ID
Ankara Medipol University
Status last verified
Sep 2020
First submitted
28 Sep 2020
Last updated
8 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Oztas M, Oztas B. Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):214-220. doi: 10.1016/j.jopan.2021.04.018. Epub 2022 Feb 10.

    PubMed 35153118

Questions about this trial

What is this clinical trial studying?

A study testing cold water spray application and cold saline spray application in people with Xerostomia and Thirst, run by Ankara Medipol University at 1 site in Turkey (Türkiye).

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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Dec 2020. 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 Turkey (Türkiye). 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. 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?

Results are not available in the source record.

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?

mouth dryness severity (time frame: Evaluation was made in the first 48 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04657913, which also lists 1 linked publication.

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 8 Dec 2020.

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