- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07358494
Effect of Diluted Thyme Honey On Dry Mouth In Intensive Care Unit Patients Exposed to Oxygen Flow Therapy
Effect of Diluted Thyme Honey On Dry Mouth In Intensive Care Unit Patients Exposed to Oxygen Flow Therapy: A Randomized Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SUMMARY
Backround Dry mouth due to nasal oxygen flow therapy is one of the side effects frequently experienced by patients treated in intensive care units. Although there are various pharmacological and complementary medicine methods for the prevention and treatment of dry mouth, this condition continues to negatively affect the daily lives of patients due to the lack of a definitive method and the neglect of oral care.
Aim The aim of this study was to evaluate the efficacy of diluted thyme honey in preventing dry mouth in intensive care patients receiving nasal oxygen flow therapy.
Desing This study has a randomized controlled experimental design.
Methods This study included 64 intensive care unit patients receiving nasal oxygen flow therapy. It was a randomized controlled experimental study consisting of intervention (thyme honey) and control group (0.9% NaCl). Participants were randomized to the groups by closed envelope method. 32 patients were included in both groups. Patients in both groups included in the study underwent the same protocol steps except for the oral care product (thyme honey and 0.9% NaCl). After obtaining consent from the patients who agreed to be included in the study, information about the participants was collected by asking the Patient Information Form prepared by the researcher. The Subjective Dry Mouth Form was administered to the participants before the start of the study and at the end of the 3rd day when the application protocols were completed. After the applications were completed, 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 were combined in the patient follow-up form.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dışkapı
-
Ankara, Dışkapı, Turkey (Türkiye), 6070
- Ankara University Institute of Health Sciences Department of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who did not meet the inclusion criteria and did not voluntarily agree to participate in the study were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: diluted 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.
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.
|
|
Placebo Comparator: 0.9% NaCl arm
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Effect of Diluted Thyme Honey on Dry Mouth in Intensive Care Patients Receiving Nasal Oxygen Flow Therapy: A Randomized Controlled Trial
Time Frame: 9 week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: ayten demir, assoc.prof.dr., Ankara University
Publications and helpful links
General Publications
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- 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.
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- 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
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- 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.
- KILAVUZ, DERVİŞ KAAN (2014). Türk Toplumunda Ağız Kuruluğu Prevalansının Araştırılması. Doktora Tezi, Gazi Üniversitesi.
- 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.
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- 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.
- 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
- 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.
- BORAHAN, M.OĞUZ (2005). Anksiyete, Depresyon, Stres ve Medikasyonun Tükürük Akış Hızı ve Subjektif Ağız Kuruluğu Üzerine Olan Etkilerinin İncelenmesi. Doktora Tezi, Marmara Üniversitesi.
- BİLGE M, TOZOĞLU Ü, 2022. Diyabetes Mellitus Olgularında Oral Mukoza Bulguları. Duzce Medical Journal, 12(2): 12 - 16.
- BİÇİCİ, BERNA (2010). Mcgill Ağrı Ölçeği Kısa Formu"nun Geçerlik Ve Güvenirliğinin İncelenmesi. Yüksek Lisans Tezi, Ege Üniversitesi.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnkaraU-esrayaprakgokturk01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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