Effect of Diluted Thyme Honey On Dry Mouth In Intensive Care Unit Patients Exposed to Oxygen Flow Therapy: A Randomized Controlled Study
Phase: NA
Conditions: Nursing Care
Sponsor: Esra Yaprak Gokturk

 
OFFİCİAL TİTLE OF THE STUDY: 
 
EFFECT OF DİLUTED THYME HONEY ON DRY MOUTH IN 
INTENSİVE CARE UNİT PATİENTS EXPOSED TO OXYGEN FLOW 
THERAPY: A RANDOMİZED CONTROLLED STUDY 
 
 
DOCUMENT TYPE: APPLICATION PROTOCOLS 
 
 
 
RESEARCHERS: 
 
• ESRA YAPRAK GÖKTÜRK (MSC) 
ANKARA UNİVERSİTY 
GRADUATE SCHOOL OF HEALT SCİENCES 
 
 
• AYTEN DEMİR (PROFESSOR DOCTOR) 
ANKARA UNİVERSİTY 
FACULTY OF NURSING 
 
 
 
 
DOCUMENT DATE: 30/11/2022  
ANKARA/TURKEY 

EFFECT OF DİLUTED THYME HONEY ON DRY MOUTH IN 
INTENSİVE CARE UNİT PATİENTS EXPOSED TO OXYGEN FLOW 
THERAPY: A RANDOMİZED CONTROLLED STUDY 
 
• NCT ID : Not Yet Assigned 
 
• Correspondance 
Esra Yaprak Göktürk (eyk1994.ek@gmail.com) (+905377819714) 
• 
Esra Yaprak GÖKTÜRK 
Nursing Department Thesis Master's Program, Institute of Health Sciences, Ankara 
University 
eyk1994.ek@gmail.com 
Clinical Trials Organization: AnkaraU 
Clinical Trials User: EYGokturk 
 
• 
Ayten DEMİR 
Faculty of Nursing, Department of Nursing, Ankara University, Ankara Türkiye 
aytendemirankara@gmail.com 
https://orcid.org/0000-0002-5677-2347 
 
• Ethics Statement 
To conduct this research, ethics committee approval (number 56786525-050.04.04/737202) 
dated November 30, 2022, was obtained from the Ankara University Rectorate Ethics 
Committee. Institutional approval (meeting number 0137) dated September 18, 2022, was 
obtained from the Ankara Training and Research Hospital, where the research was conducted. 
This study was completed as a master's thesis in the Nursing Department program at Ankara 
University, Institute of Health Sciences. 
 
• Data Availability Statement 

We have confirmed that the methods used in data analysis are appropriate. They were applied 
to our data within the study design and context, and the statistical results were applied and 
interpreted correctly. As a condition of journal submission, we accept responsibility for 
ensuring that the selection of statistical methods is appropriate and is performed and interpreted 
correctly. The data and original materials contained in this study can be obtained by contacting 
Esra Yaprak Göktürk, one of the authors of this study, at eyk1994.ek@gmail.com 
 
 

 
APPLICATION PROTOCOLS 
During the implementation period, a total of 136 patients were hospitalized in both intensive care units. 
Forty-eight of these patients were not included in the study because they did not meet the inclusion 
criteria. Five patients refused to participate in the study. 
Tools and Equipments to be used during the application 
- Thyme honey 
- Distilled water 
- Kidney bathtub 
- 0.9% NaCl 
- Disposable cup 
- Pine-tipped injector 
 
Procurement of Thyme Honey Used During the Application, Chemical Analysis and Certificates 
of the Company 
Thyme honey used during the study was obtained from a supermarket chain. Information about the 
manufacturer company was not included in the thesis to avoid conflict of interest. However, the 
necessary documents were submitted to the relevant institutions when obtaining ethics committee and 
institutional permission. The chemical analysis of the thyme honey to be used during the application 
was carried out by the producer company and complies with the standards of the Turkish Accreditation 
Agency (Türkak). The analyzes and certificates published by the producer company are presented in the 
annex by hiding the company information. 
Dilution Ratio of Thyme Honey to be used during the application 
The thyme honey solution to be used in the study was prepared by the researcher. For every 100 ml of 
distilled water, 20 ml of thyme honey was diluted.  
 
Intervention Group Implementation Protocol 
- After obtaining informed consent from the participants who agreed to be included in the study, they 
were asked to draw one sealed envelope from a bag containing sealed envelopes with numbers from 1 
to 64. The envelopes drawn by the patients were opened in the presence of the patient. According to the 
number on the envelope, the researcher determined whether the patients were included in the 
intervention or control group. 
- The participants included in the intervention group were first asked the Patient Information Form. 
Then, the questions in the 'Subjective Dry Mouth Evaluation Form' using the Visual Comparison Scale 
were asked to the participants before starting the application. Each score given in response to the 
questions was recorded in the Patient Follow-up Form. 
- Patients were educated about the importance of dry mouth, the types of foods and liquids to avoid, the 
necessity of adequate salivation, the functions of saliva, methods of coping with dry mouth, and the 
necessary precautions to identify and report any side effects that may occur due to thyme honey (as part 
of the safety of the application). 
- Patients were questioned at the beginning of the study whether they had a known allergy to the honey 
used, and no unknown allergic reaction was encountered in the patients after the application started. In 
case of a possible allergic reaction, the necessary medical intervention was planned to be given by 
healthcare professionals under intensive care conditions. 
- For the reliability of the study, the applications were performed by a single nurse practitioner. Before 
starting the study, the nurse practitioner was given detailed information about dry mouth, its importance, 
types of foods and liquids that may cause dry mouth, the necessity of adequate salivation, the functions 

of saliva, methods of coping with dry mouth, the need to report a reaction that may develop in the patient 
due to thyme honey, how to apply the solutions and the forms and scales included in the study. The 
nurse practitioner was a nurse from outside the institution with an intensive care nursing certificate.    
The nurse practitioner was present at the relevant institution during practice hours. 
- A mouthwash solution was prepared by mixing each 20 ml of thyme honey with 100 ml of distilled 
water by the researcher using a pine-tipped syringe. The prepared solution was delivered to the nurse 
practitioner. The nurse practitioner gave the solution to the patient through disposable cups. 
- The application was repeated four times a day for three days during the patient's intensive care 
treatment at 12:00-18:00-24:00-06:00 hours. Patients who were hospitalized in intensive care outside 
the application hours were included in the study at the nearest standard application time. Patients were 
instructed to gargle for at least 30 seconds by taking the entire solution into the mouth and to slowly 
spread the solution over the oral and pharyngeal mucosa. Patients were informed in advance not to 
swallow the gargling solution and were expected to remove the solution into the kidney tub at the end 
of the application. 
- At the end of the third day, the questions in the Subjective Dry Mouth Evaluation Form were asked to 
the patients again and dry mouth was evaluated again. The answers were recorded in the Patient Follow-
up Form. 
 
Control Group Application Protocol 
- After obtaining informed consent from the participants who agreed to be included in the study, they 
were asked to draw one sealed envelope from a bag containing sealed envelopes with numbers from one 
to 64. The envelopes drawn by the patients were opened in the presence of the patient. Patients were 
assigned to the intervention or control group according to the number on the envelope. 
- The participants in the control group were first asked the Patient Information Form. Then, the questions 
in the Subjective Dry Mouth Evaluation Form were asked to the participants before starting the 
application. Each score given in response to the questions was recorded in the Patient Follow-up Form. 
- Patients were educated about the importance of dry mouth, the types of foods and liquids to avoid, the 
necessity of adequate salivation, the functions of saliva, methods of coping with dry mouth, and the 
necessary precautions to identify and report any side effects that may occur due to thyme honey (as part 
of the safety of the application). 
- Since the study was to be conducted in a double-blind design, both the nurse practitioner and the 
patients did not know which group they were in. The solutions were prepared by the investigator and 
given to the nurse practitioner. For the reliability of the study, the applications were performed by a 
single nurse practitioner. Before starting the study, the nurse practitioner was given detailed information 
about dry mouth, its importance, types of foods and liquids that may cause dry mouth, the necessity of 
adequate salivation, the functions of saliva, methods of coping with dry mouth, the need to report any 
reaction that may develop in the patient due to thyme honey, how to apply the solutions and the forms 
and scales included in the study. The nurse practitioner was a health professional who worked outside 
the hospital and had an intensive care nursing certificate. 
- The mouthwash solution was prepared with 120 ml NaCl drawn by the researcher using a pine-tipped 
syringe. The prepared solution was delivered to the nurse practitioner. The nurse practitioner gave the 
solution to the patient through disposable cups. 
- The application was repeated four times a day at 12:00-18:00-24:00-24:00-06:00 hours for three days 
during the intensive care treatment of the patient. Patients were instructed to gargle for at least 30 
seconds by taking the entire solution into the mouth and to slowly spread the solution on the oral and 
pharyngeal mucosa. Patients were informed in advance not to swallow the gargling solution and were 
expected to remove the solution into the kidney tub at the end of the application. 

- At the end of the third day, the questions in the Subjective Dry Mouth Evaluation Form were asked to 
the patients again and dry mouth was evaluated again. The answers were recorded on the Patient Follow-
up Form. 
 
DATA COLLECTION TOOLS  
Patient Information Form, 'Subjective Dry Mouth Evaluation Form' prepared by using Visual 
Comparison Scale and Patient Follow-up Form were used to collect the data of the study.  
 
Patient Information Form  
It was created by the researcher based on previous studies. In total, there are 13 question titles with 
subheadings. This form includes the patient number, the practice group the patient is included in, the 
patient's diagnosis, the patient's age, the patient's gender, the patient's chronic diseases, the patient's 
previous diseases, the patient's treatments for previous diseases (radiotherapy-chemotherapy), the 
patient's continuous medications, the patient's medications used in the hospital environment, the patient's 
allergy status, the patient's oral health assessment (teeth, oral care habits, presence of existing carious 
teeth, use of tobacco products, feeling of dry mouth before receiving nasal oxygen flow treatment). In 
addition, at the end of the study, patients were asked an open-ended question about their opinions on 
thyme honey. 
Subjective Dry Mouth Assessment Form 
This form was prepared by Duruk in 2012 in line with the literature. In order to evaluate dry mouth, 
“dry mouth”, “difficulty swallowing”, “difficulty speaking”, “waking up from sleep”, “dry tongue”, 
“burning in the mouth”, “burning in the throat”, “dry throat”, “thirst”, “bad taste in the mouth”, There 
are questions about the symptoms of “saliva quantity” and “bad breath”, and the answers are evaluated 
by scoring between 0-10 using 11 Visual Analogue Scale (VAS) for each question. Scoring starts with 
0-“not at all” and 10-“very much”. 
The Visual Comparison Scale (VSS) used in the form is accepted as a safe, valid and usable 
measurement tool that is ten cm long, can be used in horizontal or vertical form, and can be used in 
repeated measurements. 
Patient Follow-up Form 
This form includes the pre-test and post-test scores of the patients in response to each question in the 
'Subjective Dry Mouth Evaluation Form' and their answers to an open-ended question about their 
opinions on thyme honey in the Patient Information Form. The purpose of this form was to facilitate 
data entry by collecting pre-test and post-test scores in a single form. 
 
Data Collection 
The data of the study were collected between November 2022 and December 2022. Before the data 
collection, the participants were informed in detail about the purpose and importance of the study and 
their written informed consent was obtained. 
In order to determine the socio-demographic characteristics and dry mouth level of the participants, the 
Patient Information Form and the Subjective Dry Mouth Evaluation Form by Duruk (2012) were used 
to evaluate the symptoms of dry mouth (dry mouth, difficulty swallowing, difficulty speaking, waking 
up from sleep due to dry mouth, dry tongue, burning in the mouth, dry throat, thirst, bad taste in the 
mouth, amount of saliva and bad odor in the mouth). The Patient Information Form and Subjective Dry 
Mouth Assessment Form were administered to the patients before the start of the study to collect their 
information and to determine their dry mouth levels. At the end of the third day, the Subjective Dry 
Mouth Assessment Form was asked once again to the patients who were included in the study and who 
were treated for three days, and their dry mouth was evaluated again. Thus, data on the dry mouth level 
of the patient before and after the intervention were collected. The scores of the patients in the 

intervention and control groups for each question in the Subjective Dry Mouth Evaluation Form before 
and after the intervention and an open-ended question about their opinions about thyme honey were 
included in the Patient Follow-up Form.