NCT07358494

Brief Summary

This research is a randomized, controlled, double-blind, experimental study conducted to investigate the effect of diluted thyme honey on dry mouth in individuals receiving treatment in intensive care and receiving nasal oxygen flow therapy. H0: There is no significant difference in reducing dry mouth in intensive care patients receiving nasal oxygen flow therapy between the intervention group receiving oral care with diluted thyme honey and the control group receiving standard oral care. The study sample consisted of 64 inpatients receiving nasal oxygen flow therapy in the Emergency Intensive Care and Emergency Critical Intensive Care Units of Ankara Training and Research Hospital. Patients were divided into groups using a sealed envelope method. Patients in the intervention group received oral care using diluted thyme honey, while patients in the control group received oral care using 0.9% NaCl.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

May 21, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

XerostomiaThyme HoneyNursingNasal Oxygen Flow Treatment

Outcome Measures

Primary Outcomes (1)

  • The Effect of Diluted Thyme Honey on Dry Mouth in Intensive Care Patients Receiving Nasal Oxygen Flow Therapy: A Randomized Controlled Trial

    The Subjective Dry Mouth Assessment Form was used to assess dry mouth. This form includes questions regarding symptoms such as "dry mouth," "difficulty swallowing," "difficulty speaking," "waking up from sleep," "dry tongue," "burning mouth," "burning throat," "dry throat," "thirst," "bad taste in the mouth," "saliva volume," and "bad breath." Responses are scored on a 0-10 scale using 11 Visual Analogue Scales (VAS). Scoring begins with 0 (not at all) and ends with 10 (extremely). The Subjective Dry Mouth Assessment Form was administered to patients before the study began to gather patient information and determine their dry mouth levels. At the end of the third day, the Subjective Dry Mouth Assessment Form was administered to the patients, who underwent three days of treatment, and their dry mouth was re-evaluated. Data on the patients' dry mouth levels were collected before and after the study.

    9 week

Study Arms (2)

diluted thyme honey arm

EXPERIMENTAL

* After obtaining informed consent from participants who agreed to participate in the study, they were asked to draw one sealed envelope from a bag containing sealed envelopes numbered from 1 to 64. The envelopes drawn by the patients were opened in their presence. The researcher determined whether the patients would be included in the intervention or control group based on the number drawn from the envelope. * Participants assigned to the intervention group were first given the Patient Information Form. Then, before starting the intervention, participants were asked questions from the "Subjective Dry Mouth Assessment Form" prepared by Duruk (2012) using the Visual Analogue Scale. Each point given in response to the questions was recorded in the Patient Follow-up Form. * Patients were educated on the importance of dry mouth, the types of foods and liquids to avoid, the necessity of adequate saliva secretion, the functions of saliva, methods of coping with dry mouth, and the necess

Other: diluted thyme honey armOther: Mouth wash

0.9% NaCl arm

PLACEBO COMPARATOR

After obtaining informed consent from participants who agreed to participate in the study, they were asked to draw one sealed envelope from a bag containing sealed envelopes with numbers ranging from 1 to 64 written on them. The envelopes drawn by the patients were opened in their presence. Patients were assigned to either the intervention or control group according to the number drawn from the envelope. * Participants in the control group were first given the Patient Information Form. Then, before starting the application, they were asked questions from the Subjective Dry Mouth Assessment Form. Each point given in response to the questions was recorded in the Patient Follow-up Form. * Patients were educated on the importance of dry mouth, the types of foods and liquids to avoid, the necessity of adequate saliva secretion, the functions of saliva, methods for coping with dry mouth, and the necessary precautions to identify and report any side effects that

Other: Mouth wash

Interventions

In this study, the usability of an alternative method for the elimination of dry mouth, which has a very important place in terms of nursing care, was investigated. The effect of diluted thyme honey on dry mouth in intensive care patients receiving nasal oxygen flow therapy, which has not been previously studied in the literature, was investigated.

0.9% NaCl armdiluted thyme honey arm

In this study, the feasibility of an alternative method for alleviating dry mouth, which is very important in terms of nursing care, was investigated. The effect of diluted thyme honey, which had not been previously studied, on dry mouth was investigated in intensive care patients receiving nasal oxygen flow therapy in the intervention group. The control group received oral care using a standard oral care solution of 0.9% NaCl.

diluted thyme honey arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being treated under intensive care conditions and receiving nasal oxygen flow therapy above 4L/min,
  • Over 18 years of age,
  • Not diagnosed with Sjögren's Syndrome,
  • No previous exposure to radiotherapy or chemotherapy,
  • Has not had a salivary gland infection,
  • Has not undergone an operation to remove the salivary glands,
  • Not allergic to honey,
  • No chewing or swallowing difficulties,
  • Not using thyme-containing products for oral care in the previous period,
  • Patients who did not have any communication problems and who voluntarily agreed to participate in the study were included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Institute of Health Sciences Department of Nursing

Ankara, Dışkapı, 6070, Turkey (Türkiye)

Location

Related Publications (35)

  • YAVUZ KARAMANOĞLU A, YAVUZ M (2015). Ağız Sağlığı Hemşirelik Değerlendirmesinde Kanıtlar Ve Uygulama Önerileri. Ege Üniversitesi Hemşirelik Fakültesi Dergisi, 31(1): 131-143.

    RESULT
  • Takzaree N, Hassanzadeh G, Rouini MR, Manayi A, Hadjiakhondi A, Majidi Zolbin M. Evaluation of the Effects of Local Application of Thyme Honey in Open Cutaneous Wound Healing. Iran J Public Health. 2017 Apr;46(4):545-551.

  • TABACHNICK B G, FIDELL L S, (2013). Using multivariate statistics. Boston:Pearson. 6: 497-516.

    RESULT
  • SEO E, SONG J, HUR M, LEE M, SOO LEE M (2017). Effects of aroma mouthwash on stress level, xerostomia, and halitosis in healthy nurses: A non-randomized controlled clinical trial. European Journal of Integrative Medicine, 10: 82-89. DOI: 10.1016/j.eujim.2017.03.001

    RESULT
  • ÖZKÖK A, KORU Ö, SORKUN K (2016). Microbiological Analysis And Antibacterial Effects Of Turkish Thyme Honey. Bee World, 93(4): 98-101. DOI: 10.1080/0005772X.2016.1275489

    RESULT
  • Lopez-Pintor RM, Casanas E, Gonzalez-Serrano J, Serrano J, Ramirez L, de Arriba L, Hernandez G. Xerostomia, Hyposalivation, and Salivary Flow in Diabetes Patients. J Diabetes Res. 2016;2016:4372852. doi: 10.1155/2016/4372852. Epub 2016 Jul 10.

  • Li Y, Taylor JM, Ten Haken RK, Eisbruch A. The impact of dose on parotid salivary recovery in head and neck cancer patients treated with radiation therapy. Int J Radiat Oncol Biol Phys. 2007 Mar 1;67(3):660-9. doi: 10.1016/j.ijrobp.2006.09.021. Epub 2006 Dec 4.

  • Lagerlof F, Dawes C. The volume of saliva in the mouth before and after swallowing. J Dent Res. 1984 May;63(5):618-21. doi: 10.1177/00220345840630050201.

  • Lafraxo H, Bakour M, Laaroussi H, El Ghouizi A, Ousaaid D, Aboulghazi A, Lyoussi B. The Synergistic Beneficial Effect of Thyme Honey and Olive Oil against Diabetes and Its Complications Induced by Alloxan in Wistar Rats. Evid Based Complement Alternat Med. 2021 Sep 20;2021:9949056. doi: 10.1155/2021/9949056. eCollection 2021.

  • Konings AW, Coppes RP, Vissink A. On the mechanism of salivary gland radiosensitivity. Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):1187-94. doi: 10.1016/j.ijrobp.2004.12.051.

  • Kobya Bulut H, Guducu Tufekci F. Honey prevents oral mocositis in children undergoing chemotherapy: A quasi-experimental study with a control group. Complement Ther Med. 2016 Dec;29:132-140. doi: 10.1016/j.ctim.2016.09.018. Epub 2016 Sep 19.

  • KILAVUZ, DERVİŞ KAAN (2014). Türk Toplumunda Ağız Kuruluğu Prevalansının Araştırılması. Doktora Tezi, Gazi Üniversitesi.

    RESULT
  • Kannarkat G, Lasher EE, Schiff D. Neurologic complications of chemotherapy agents. Curr Opin Neurol. 2007 Dec;20(6):719-25. doi: 10.1097/WCO.0b013e3282f1a06e.

  • Hashemian F, Baghbanian N, Majd Z, Rouini MR, Jahanshahi J, Hashemian F. The effect of thyme honey nasal spray on chronic rhinosinusitis: a double-blind randomized controlled clinical trial. Eur Arch Otorhinolaryngol. 2015 Jun;272(6):1429-35. doi: 10.1007/s00405-014-3233-x. Epub 2014 Aug 9.

  • Hanchanale S, Adkinson L, Daniel S, Fleming M, Oxberry SG. Systematic literature review: xerostomia in advanced cancer patients. Support Care Cancer. 2015 Mar;23(3):881-8. doi: 10.1007/s00520-014-2477-8. Epub 2014 Oct 18.

  • GEORGE D, MALLERY M (2010). SPSS for Windows Step by Step: A Simple Guide and Reference, 17.0 update (10a ed.) Boston: Pearson

    RESULT
  • Ganjre A, Kathariya R, Bagul N, Pawar V. Anti-carcinogenic and Anti-bacterial Properties of Selected Spices: Implications in Oral Health. Clin Nutr Res. 2015 Oct;4(4):209-15. doi: 10.7762/cnr.2015.4.4.209. Epub 2015 Oct 31.

  • Fantozzi PJ, Pampena E, Di Vanna D, Pellegrino E, Corbi D, Mammucari S, Alessi F, Pampena R, Bertazzoni G, Minisola S, Mastroianni CM, Polimeni A, Romeo U, Villa A. Xerostomia, gustatory and olfactory dysfunctions in patients with COVID-19. Am J Otolaryngol. 2020 Nov-Dec;41(6):102721. doi: 10.1016/j.amjoto.2020.102721. Epub 2020 Sep 10.

  • DURUK NAZİKE (2012). Hemodiyaliz Sırasında Ciklet Çiğnemenin Ağız Kuruluğu Ve Semptomlarına Etkisi. Doktora Tezi, Ege Üniversitesi.

    RESULT
  • DAVIES A N. EPSTEIN J B (2010). Salivary gland dysfunction Oral Complications of Cancer and its Management. Oxford University Press, p: 203-223. DOI: 10.1016/j.gerinurse.2015.10.014

    RESULT
  • Dalodom S, Lam-Ubol A, Jeanmaneechotechai S, Takamfoo L, Intachai W, Duangchada K, Hongsachum B, Kanjanatiwat P, Vacharotayangul P, Trachootham D. Influence of oral moisturizing jelly as a saliva substitute for the relief of xerostomia in elderly patients with hypertension and diabetes mellitus. Geriatr Nurs. 2016 Mar-Apr;37(2):101-9. doi: 10.1016/j.gerinurse.2015.10.014. Epub 2015 Nov 26.

  • Crogan NL. Managing xerostomia in nursing homes: pilot testing of the Sorbet Increases Salivation intervention. J Am Med Dir Assoc. 2011 Mar;12(3):212-6. doi: 10.1016/j.jamda.2010.06.002. Epub 2010 Oct 8.

  • Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.

  • Charalambous M, Raftopoulos V, Paikousis L, Katodritis N, Lambrinou E, Vomvas D, Georgiou M, Charalambous A. The effect of the use of thyme honey in minimizing radiation - induced oral mucositis in head and neck cancer patients: A randomized controlled trial. Eur J Oncol Nurs. 2018 Jun;34:89-97. doi: 10.1016/j.ejon.2018.04.003. Epub 2018 Apr 30.

  • Charalambous A, Lambrinou E, Katodritis N, Vomvas D, Raftopoulos V, Georgiou M, Paikousis L, Charalambous M. The effectiveness of thyme honey for the management of treatment-induced xerostomia in head and neck cancer patients: A feasibility randomized control trial. Eur J Oncol Nurs. 2017 Apr;27:1-8. doi: 10.1016/j.ejon.2017.01.001. Epub 2017 Jan 16.

  • BORAHAN, M.OĞUZ (2005). Anksiyete, Depresyon, Stres ve Medikasyonun Tükürük Akış Hızı ve Subjektif Ağız Kuruluğu Üzerine Olan Etkilerinin İncelenmesi. Doktora Tezi, Marmara Üniversitesi.

    RESULT
  • BİLGE M, TOZOĞLU Ü, 2022. Diyabetes Mellitus Olgularında Oral Mukoza Bulguları. Duzce Medical Journal, 12(2): 12 - 16.

    RESULT
  • BİÇİCİ, BERNA (2010). Mcgill Ağrı Ölçeği Kısa Formu"nun Geçerlik Ve Güvenirliğinin İncelenmesi. Yüksek Lisans Tezi, Ege Üniversitesi.

    RESULT
  • BENLİ M, YİĞİT KAYHAN N (2005). Ülkemizde Yaygın Kullanımı Olan Kekik (Thymus Vulgaris) Bitkisinin Antimikrobiyal Aktivitesi. Orlab On-Line Mikrobiyoloji Dergisi , 3(8) 1-8.

    RESULT
  • Bardy J, Molassiotis A, Ryder WD, Mais K, Sykes A, Yap B, Lee L, Kaczmarski E, Slevin N. A double-blind, placebo-controlled, randomised trial of active manuka honey and standard oral care for radiation-induced oral mucositis. Br J Oral Maxillofac Surg. 2012 Apr;50(3):221-6. doi: 10.1016/j.bjoms.2011.03.005. Epub 2011 Jun 1.

  • Bardy J, Slevin NJ, Mais KL, Molassiotis A. A systematic review of honey uses and its potential value within oncology care. J Clin Nurs. 2008 Oct;17(19):2604-23. doi: 10.1111/j.1365-2702.2008.02304.x.

  • ATASOY, BESTE MELEK (2002). Radyoterapi Gören Baş Boyun Tümörlü Hastalarda Oluşan Akut ve Konik Kserostominin Amifostin ile Azaltılabilirliğinin İncelenmesi. Uzmanlık Tezi, Marmara Üniversitesi.

    RESULT
  • ARSLANTAŞ TAMARA (2009). Kserostomi Oluşturulan Rat Modelinde Gastrik Reflünün Östaki Tüp Fonksiyonları Üzerine Olan Olumsuz Etkilerine Karşı Tükürüğün Koruyucu Etkileri. Uzmanlık Tezi, Süleyman Demirel Üniversitesi.

    RESULT
  • Anggraeni DT, Hayati AT, Nur'aeni A. The effect of oral care using honey as an additional topical agent on oral health status of intubated patients in the intensive care unit. Enferm Intensiva (Engl Ed). 2022 Oct-Dec;33(4):225-232. doi: 10.1016/j.enfie.2021.12.004.

  • Bahramnezhad F, Dehghan Nayeri N, Bassampour SS, Khajeh M, Asgari P. Honey and Radiation-Induced Stomatitis in Patients With Head and Neck Cancer. Iran Red Crescent Med J. 2015 Oct 22;17(10):e19256. doi: 10.5812/ircmj.19256. eCollection 2015 Oct.

MeSH Terms

Conditions

Xerostomia

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • ayten demir, assoc.prof.dr.

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Randomization Participants included in the study were assigned to the intervention or control groups using a simple randomization method involving envelopes. Numbers ranging from 1 to 64, representing patient numbers, were automatically distributed at random via the website https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php, thereby creating "Set 1." It was determined that the first 32 of the 64 randomly arranged numbers in 'Set 1' would represent patients in the intervention group, and the last 32 would represent patients in the control group. After obtaining consent from the patients participating in the study, they were asked to draw one sealed envelope from a bag containing sealed envelopes with numbers from 1 to 64 written on them. The envelopes drawn by the patients were opened in their presence. The researcher determined which group the patients would be included in, either the intervention or control group, based on the number that came out of the
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study has a randomized controlled experimental design.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSN: Master of Science in Nursing

Study Record Dates

First Submitted

May 21, 2025

First Posted

January 22, 2026

Study Start

October 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations