Impact of Using Pure Natural Honey as a Topical Application for Patients Who Receiving Chemotherapy Regimen on Reducing Risk of Stomatitis

Introduction

Stomatitis is a common side effect of chemotherapy and is characterized by pain, erythema, ulcerations and inflammation of the surface of the mucous membrane in the oral cavity. It develops as a direct result of chemotherapy destroying healthy cells in the mouth. Overall, 40% of people who have chemotherapy as part of their cancer treatment will develop some degree of stomatitis.  Its severity depends on the type of chemotherapeutic agent and the dose used ⁽¹⁾.

The provision of effective oral care is a fundamental and essential element of nursing practice in oncology setting. Nurses and medical staff have a vital role in the promotion of good oral health and hygiene, in preventing discomfort and inadequate nutrition, in detecting oral disease in the early stages and in improving outcomes for patients.  The prevention of deterioration in patient's teeth and mouth will be less costly than the treatment of the oral and systemic diseases that occur as a consequence of poor oral health ⁽²⁾.

Oral assessments should be carried out at regular intervals to monitor the effectiveness of oral hygiene interventions and their impact on oral health, identification of risks for oral Health problems. As well as encourage oral hygiene after meals and before going to bed .If specific problems such as swallowing difficulties are identified, the patient should be referred to physician.  Assistance should be provided to maintain independence, with the use of aids to oral hygiene and techniques such as prompting, applying toothpaste to the brush, guiding the person’s hand, and providing appropriate support for denture care and hygiene.  Clean lips with water-moistened gauze and protect with a lubricant to minimize the risk of dry, cracked and uncomfortable lips ^{(3, 4)}.

Operational definition

Clover honey is a variety of honey made by bees that are fed clover. Depending on the location and source, clover honey varies in color from water white to different tones of amber.  Honey contains a variety of phytochemicals (as well as other substances such as organic acids, vitamins, and enzymes) that may serve as sources of dietary antioxidants. Clover contains higher water content and a larger proportion of glucose relative to fructose. As a result, clover honey tends to have a higher water content, which may permit it to crystallize more readily over time (5).

Aim of the study

The aim of the present study was to evaluate impact of using pure natural honey as a topical application for patients who receiving chemotherapy regimens on reducing risk of stomatitis through:

• Assess patients who receiving chemotherapy and free from stomatitis degree.
• Prepare and implement of using pure natural honey as a topical application for patients     who receiving chemotherapy regimen on reducing risk of stomatitis.
• Evaluate the effectiveness of using pure natural honey as atopical application for patients who receiving chemotherapy regimen on reducing risk of stomatitis.

Research hypothesis

• Using pure natural honey as an oral topical application for patients who receiving chemotherapy regimens will reduce risk and degree of stomatitis.

Subjects and Methods

Research Design:

Quasi-experimental research design was utilized in the current study.

Setting:

The current study was carried out at oncology center in Minia city in chemotherapy outpatient clinic, inpatient and outpatient chemotherapy department. The chemotherapy outpatient clinic is located in the first floor which is one room for examination. The inpatient chemotherapy department is located in third floor. It consists of   two rooms one for adult male and one for adult female; each one contains 4-5 beds .However, the another outpatient chemotherapy department is located in the fourth floor. It consists of two rooms one for adult male and one for adult female; each one contains 4 beds.it affilted by General Secretariat of specialized medical centers, Ministry of health.

Subjects:

A sample of purposive including (60) male and female adult patients who were willing to participate in the current study, classified equally (no.=30)for study group and (no.=30)for control group according to the determination of the sample size is based upon the following sample calculation formula: http://www.ifad.org/gender/tools/hfs/ anthropometry).

Description:

N = required sample size

t = confidence level at 95 % (standard value of 1.960)

p = estimated prevalence of stomatitis in chemotherapy patient at Minia city oncology center 2014 (0.04)

m = margin of error at 5 % (standard value of 0.050).

Both groups of current study were selected according to the following inclusion and exclusion criteria:   

Inclusive criteria:

1. All adult patients newly admitted to oncology center one week before the first dose of starting chemotherapy.
2. Conscious patients who were able to use mouth care.
3. Patients with all types of cancer newly ordered for chemotherapy.
4. Both sexes (male and female).

Exclusive criteria:

1. Patients has past history of recurrent stomatitis
2. Patient with past history of anemia (hemoglobin less than 10gm)
3. Patient receiving immunosuppression medication
4. Hypersensitivity to honey
5. Diabetes mellitus.
6. Liver cirrhosis  

Tools of data collection:

Three tools were utilized to collect data pertinent for this current study.  Two tools are standard and one tool was developed by the researcher, and then reviewed by a panel of   five experts, these tools are:

Tool 1: Patient's biosociodemographic Characteristic: structured interview tool to collect pertinent data related to the following :( age, gender, marital status, medical diagnosis, hospital stay duration, body weight … etc.

It was adopted from ⁽⁶⁾ and modified by the researcher after revising extensive literature review.

Tool 2: Beck Oral Assessment Scale (BOAS); It is adopted from ⁽⁷⁾ which was assess the condition of the study sample's (study and control) oral cavity. Consists of five items that assess the lips, gingiva, tongue, teeth, and saliva by inspection. The scale graded from one (1) which mean normal manifestations to four (4) which mean highest degree of abnormal manifestations. The total score of this scale classified into four results as following: five (5): No dysfunction, six to ten(6-10): Mild dysfunction, eleven to fifteen(11-15): Moderate dysfunction, sixteen to twenty (16- 20) : severe dysfunction.                                  

Tool 3: oral toxicity Scale .It is adopted from ⁽⁸⁾ to assess any presence of stomatitis symptoms. It consist of five symptoms, which grading from zero(0):none(no description),one(1):mild stomatitis , (2) :moderate stomatitis ,three(3) :severe stomatitis ,four (4): (Life threatening or oral alimentation impossible).

Validity of tools

Tools content validity was done to identify the degree to which the used tools measure what was supposed to be measured. The developed tools were examined by a panel of five experts in the field of the study (Minia University , Assiut University - faculty of nursing (Medical Surgical Nursing Department) and faculty of agriculture-plant protection department (Beekeeping Specialty).All jury member (100%) agree that current study tools were valid and relavant with the aim of the study . A pilot study was carried out on 6 patients (10%) of the total sample to test feasibility, objectivity, and applicability of the tools. Results of the pilot study illustrated that no any refinements and modifications needed so the subjects were included to the actual sample.

Reliability of tools

Cronbach's alpha for reliability testing internal consistency was performed for each section for World Health Organization (WHO) Oral Toxicity Scale tool and Beck Oral Assessment Scale (BOAS) it was found ( 0.91,0.95) Respectively.

Ethical Consideration

An official permission to conduct the study was obtained from the ethical committee in the faculty of nursing, dean of nursing faculty, oncology institute director, research center afflicted to Egypt Ministry of Health and agreement from Egypt academic for research center and technology. Written consents were obtained from subjects who were informed about the purpose, procedure, benefits, nature of the study, follow up and his/her had the right to withdraw from the study at any time without any rational. Confidentiality and anonymity of each subject were ensured through coding of all data and protecting the obtained data.

Procedure

The current study was conducted by preparing of different data collection tools, in addition obtaining formal paper agreement which was taken induration one month before conducting the study. The researcher was bought many bottle of honey from plant protection department (Beekeeping specialty) faculty of agriculture - Minia University before starting implementation of the current study. The total data Collection were collected over a period of eight months starting from October 2015 to May 2016. The researcher carry out the study on daily basis during morning shift in chemotherapy outpatient clinic to select patients relevant with study free from stomatitis.

The researcher was started collection of data by using three tools from control group firstly after that starting data collection from study group, when both sample were in outpatient clinic-inpatient chemotherapy department. The number of sessions for data collection from control group was nine sessions ,its duration ranged from 20 to 30 minute, in addition telephone interview for follow up presence of oral dysfunction and stomatitis symptoms while sessions duration for study group was 45-60 minute because they perform training and educational practices (tool 4):(hand washing and mouth care with honey application ),this training include two parts: First part: standard hand washing   procedure which include 15steps ⁽⁹⁾ .Second part: mouth care with honey application which include 15 steps. Classified into two domains 1. First domain (rinse with saline solution from step (1-8)⁽¹⁰⁾. 2. Second domain (honey application from step (9-15) ⁽¹¹⁾. Both previous parts grading from 2 (do the procedure) to 1(didn't the procedure). In addition telephone interview for follow up presence of oral dysfunction and stomatitis symptoms during frequency between chemotherapy sessions range from 2 to 3 weeks.

Limitation of the study

1. Formalities from the oncology center toward the study.
2.  Some patients discontinue proceeding in current study due to their refusing training and educational practices or not completing their treatment session and the researcher excluded them from the study sample   .
3. Cost of honey and normal saline 0.9% is high and the hospital not supported by any facilities to apply this study.

Statistical analysis of data

Data were summarized, tabulated, and presented using descriptive statistics in the form of frequency distribution, percentages, means and the standard deviations as a measure of dispersion. A statistical package for the social science (SPSS), version (20) was used for statistical analysis of the data, as it contains the test of significance given in standard statistical books. Numerical data were expressed as mean and SD.

Results

Table (1) Socio demographic characteristics of study & control groups (n= 60).

NS= not significant

It shows that  , the mean average age among study group  was 45.7 ± 12.6 years old  and more than two third (66.7 % ) among them their gender were female  while the mean  average age among  control group  were 47.6 ± 11.9 years old  and their gender  were female constituted (70%) . As regard marital status for both groups, the highest percentage among study and control groups were married constituted (90%&80%) respectively. Nearly similar percentage (70%&76.7%) & (60%&63.3%) respectively among study and control groups their level of education and occupation were illiterate and house wives. Most of the study sample (study and control group) was lived in rural area constituted (96.7% &86.7%) respectively.

Table (2) Percentage distribution of the study sample as regards medical information data (n= 60).

NS= not significant                ** highly statistically significant

It shows that, as regard medical diagnosis for study and control groups results represented that, half of them were diagnosed as cancer colon and their length of hospital stay duration was between 1 or 3 days constituted (50%) , the table illustrated  that all (100%) of study sample (study and control groups)  had no  experience regard  using of honey application  . as regard the variance in body weight  pre and post chemotherapy , there is gain of weight (1-6 kg )  in 43.3% of the study group  while there is loss of body weight (1-4 kg ) in  60%  of control group  , there  were  a  highly statistical  significant difference  between study and control groups.

Table (3) Differences of beck oral assessment scale (BOAS manifestations) among study and control groups post three sessions of chemotherapy (n= 60).

* p ≤.05                 ** p ≤.01                                 (BOAS): Beck Oral Assessment Scale

It shows that, there was a highly statistical significant difference regard BOAS manifestations between study and control groups during third observation for them post first session of chemotherapy. Also, there was a highly statistical significant difference among same groups during three observations post second and third session of chemotherapy.

Table (4) Differences of (WHO) Oral Toxicity Scale among study & control groups post three sessions of chemotherapy (n= 60).

(WHO): World Health Organization

It displays that, there was a highly statistical  significant difference  among study and control groups regard degree of stomatitis  during third observation post first session of chemotherapy   &  also there was a highly statistical  significant difference  among same groups during three observations post second and third session of chemotherapy . Results also revealed that statistical significant difference among both groups regard degree of stomatitis only during second observation post first session of chemotherapy. The table illustrated that the percentage of oral stomatitis degree occurs among study group in three sessions were (0.0%, 3.3%, 6.7%) in the three observations respectively.

Table (5) Correlations between socio demographic data regard to beck oral assessment scale (BOAS) and oral toxicity scale (sum of three sessions) for the study and control groups.

It shows that, there was no statistical significant correlation between socio demographic data for study and control groups with result of beck oral assessment scale (BOAS) post three sessions of chemotherapy. Also there was no statistical significant correlation between socio demographic data for study and control groups with result of oral toxicity scale except for age among study group, a correlation was found with previous scale post three sessions of chemotherapy.

Table (6) Correlations between beck oral assessment scale (BOAS) and oral toxicity scale (sum of three sessions) for the study and control groups.

It shows that, there was strong positive correlation between result of beck oral assessment scale (BOAS) and oral toxicity scale among study and control groups post three sessions of chemotherapy.

Table (7) Correlations between medical data regard to BOAS and Oral toxicity scale (sum of three sessions) for the study and control groups.

* p = ≤.05 (statistical significance)

** p = ≤.01 (highly statistical significance)

It shows that, there was no statistical significant correlation between all medical data for study and control groups with result of beck oral assessment scale (BOAS) and oral toxicity scale except Variance in body weight between pre & post chemotherapy among study group, a correlation was found with beck oral assessment scale (BOAS) only post three sessions of chemotherapy.