Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04657913
Other study ID # Ankara Medipol University
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date January 31, 2021

Study information

Verified date September 2020
Source Ankara Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. This research was conducted as a randomized controlled trial.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 108
Est. completion date January 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
cold water spray application
It will be sprayed into the mouth of patients every hour.
cold saline spray application
It will be sprayed into the mouth of patients every hour.

Locations

Country Name City State
Turkey Gulhane Education and Training Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Evaluation was made in the first 48 hours after surgery
Primary 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. Evaluation was made in the first 48 hours after surgery
Primary 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. Evaluation was made in the first 48 hours after surgery
Primary oral condition The Oral Health Assessment Tool were used. As the score on the scale increases, the oral condition worsens. Evaluation was made in the first 48 hours after surgery
Secondary patient satisfaction assessed by the VAS VAS will be used, numbered between 0-10, 0: not satisfied at all, 10: very satisfied. It were evaluated at 48th hours postoperatively.
See also
  Status Clinical Trial Phase
Completed NCT05342272 - Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction Phase 3
Completed NCT03302676 - The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors N/A
Completed NCT02375451 - Effect of Childhood Radioiodine Therapy on Salivary Function N/A
Completed NCT01272570 - Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors N/A
Completed NCT00656513 - Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer Phase 2/Phase 3
Completed NCT00911768 - Effect of Korean Red Ginseng (KRG) on Dry Mouth Phase 4
Completed NCT00332618 - Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia Phase 2
Completed NCT03494985 - A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water N/A
Completed NCT05058430 - SaliPen Human Factors Study for OTC Labeling N/A
Recruiting NCT02705937 - Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications. N/A
Completed NCT05247008 - Effectiveness of Thyme Honey in Management of Xerostomia in ESRD N/A
Recruiting NCT03632096 - Photobiomodulation in Salivary Production of Patients With Xerostomy Phase 2
Not yet recruiting NCT04323384 - The Effect of Biotene® on the Symptoms of Xerostomia and Mastication and Swallowing N/A
Not yet recruiting NCT03530735 - Finger-prick Autologous Blood (FAB) for Use in Dry Mouth N/A
Active, not recruiting NCT03176368 - Coconut Oil: Managing Radiation-Induced Xerostomia N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Completed NCT03611283 - Topical Management of Xerostomia With Dry Mouth Products N/A
Completed NCT02682199 - Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
Withdrawn NCT01960101 - Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication N/A
Completed NCT02317172 - Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases N/A