The malignant neoplasm characterized by the proliferation of anaplastic cells that tend to invade surrounding tissue. Mucositis are described as an inflammatory and ulcerative reaction in the oral cavity. It develops in an average 40% of patients administered systemic chemotherapy. Oral mucositis developing in the patient may cause pain ranging from mild to unbearly become severe and enough to interference with eating and it can require hospitalization for fluid support. Cryotherapy administered during rapid infusion of a chemotherapeutics agents gives raise local vasoconstriction, which in turn decrease blood flow in oral mucosa and reduced the amount of drug distributed to cells hence reducing the incidence of mucositis. Cold application is a simple and inexpensive which has been accepted for decades of as an effective non pharmacologic intervention for pain management. Objectives: 1. To assess the oral mucositis among Chemotherapy patients in control and experimental group before and after cryotherapy. 2. To compare the effectiveness of cryotherapy on oral mucositis among Chemotherapy patients in control and experimental group. 3. To find out the association between post test scores of oral mucositis among Chemotherapy patients in control and experimental group with their demographic variables. Materials and Methods: The study used an Evaluation approach and quasi experimental design to collect the data from Cancer centre selected by purposive sampling method. The target population for this study was Chemotherapy patients. The sample size was determined 10 for control group and 10 for experimental group. The data were collected for 2 weeks after obtaining permission from the concerned authority of the Hospital. Pretest was conducted for 3-5 patients per day and immediately after pretest cryotherapy was given for 15-20 minutes in one time a day for 7 days. Weatern Consortium Observational tool was used on 7th day after completion of cryotherapy and the level of oral mucositis was graded in the percentage of scores. Results: Comparison of Mean, SD of control group pre and posttest scores reveals that, in pretest the mean score was 6.4 and posttest mean score was 8.3. It depicts that without intervention of cryotherapy on oral Mucositis was not effective. Comparison of Mean of experimental group pre and posttest scores reveals that, in pretest the mean score was 8.1 and posttest mean score was 4. It depicts that cryotherapy on oral Mucositis was effective among chemotherapy patients.
Cancer is a group of disease characterized by uncontrolled cell division leading to growth of abnormal tissue. It is believed that cancers arise from both genetic and environmental factors that lead to aberrant growth regulation of a stem cell population. Cancer affects people at all ages with the risk for most types increasing with ages. It caused about 13% of all human deaths in 2017.
Common environmental factors leading to cancer include tobacco (25-30), diet and obesity (30-35), infections (15-20), radiation, stress, physical activity, environmental pollutants. Pain is a complex, multidimensional experiences, it is major problem that causes suffering and reduces the quality of life. Cancer and chemotherapy are amongst leading health problems influencing the quality of life of individual. The complications of many treatment regimens appear frequently in the month of patients and causes serious disturbances.
Recent investigation has demonstrated that much serious infection originates from mouth and antineoplastic chemotherapy and immune suppressive drugs increase the susceptibility of patients. Mucositis is a complication of cancer treatment, reducing quality of life. Mucosities is described as an inflammatory and ulcerative reaction in the oral cavity. It develops in an average of 40% of patients administered systemic chemotherapy and radiotherapy to the head and neck. Typically, it begins with mouth and tongue soreness and progress to painful ulcerative of oral cavity and lips [1].
Cryotherapy refers to the practice of using cold for the management of pain and edema after surgery. Cryotherapy is used to produce analgesic, decrease pain by alpha, beta and C fibre stimulation, reduce muscle spasm by decreased muscle spindle activity, reduce inflammation by decreased vascular response, reduce edema by vasoconstriction and reduce haemorrhage by minimizing effects of active bleeding. At the same time, the ice enhances the flow of nutrients into the area, aids in the removal of waste products increases strength and promotes healing [2].
Oral cooling has become popular as a cheap and readily applicable method in preventing or decreasing oral mucositis developed due to rapid infusion of chemotherapy agents. A cardinal responsibility in nursing is to provide comfort and relieve distress. Therefore one of the methods that can be used to relieve pain is cryotherapy.
Need for the Study
Cancer is the malignant growth or tumour caused by abnormal and uncontrolled cell division and it may spread to other parts of the body through the lymphatic. Cold application is a simple and inexpensive which has been accepted for decades of as an effective non pharmacologic intervention for pain management. It is most effective self care techniques for injury, pain or discomfort in muscles and joints. Ice will decrease muscle spasms, pain and inflammation to bone and soft tissue. During the post operative period, most of the patients were experiencing severe pain. Cryotherapy (Cold application) has been shown to reduce the pain effectively [3].
Statement of the Problem
A study to assess the effectiveness of cryotherapy on oral mucositis among chemotherapy patients at Cancer Centre, Erode, Tamilnadu.
Objectives
To assess the oral mucositis among Chemotherapy patients in control and experimental group before and after cryotherapy
To compare the effectiveness of cryotherapy on oral mucositis among Chemotherapy patients in control and experimental group
To find out the association between post test scores of oral mucositis among Chemotherapy patients in control and experimental group with their demographic variables
Review of Literature
Cancer is the cell or a group of cells display uncontrolled growth, invasion and sometimes metastasis. Cancer occurring due to alcohol use, tobacco use, modified life style factors, intake of more fat diets, viruses like Epstein Barr viruses, Hepatitis B and C, chemicals such as Pesticides, Uranium, Nickel, Asbestos, Radon and Benzene. The complications are pain, oral mucositis, depression, nausea, insomnia, fatigue, anorexia, hair loss and mental disorders [4].
Oral mucositis often develop when patients treated with high dose chemotherapy combined with irradiation therapy. Cryotherapy with ice tips to be commenced 15 minutes before L-PAM administration and to be continued until the end of administration. By wearing protective clothing and sunscreens and avoiding prolonged exposure to the skin may reduce the risk of skin cancer. Healthy food may help to reduce the cancer risk like fibre, vitamins, minerals and low fat items [5].
Hypothesis
H1: There is a significant improvement in the oral mucositis among chemotherapy patients in control and experimental group
H2: There is a significant effectiveness of cryotherapy on oral mucositis among chemotherapy patients in experimental group then the control group
H3: There is a significant association between posttest scores of oral mucositis among chemotherapy patients in control and experimental group with their demographic variables
The study used a Evaluation approach and quasi experimental design to collect the data from Cancer Centre selected by purposive sampling method. The target population for this study was Chemotherapy patients. The sample size was determined 10 for control group and 10 for experimental group. The data were collected for 2 weeks after obtaining permission from the concerned authority of the Hospital. Pre test was conducted for 3-5 patients per day and immediately after pre test cryotherapy was given for 15-20 minutes in one time a day for 7 days. Weatern Consortium Observational tool was used on 7th day after completion of cryotherapy and the level of oral mucositis was graded in the percentage of scores.
Demographic data was analyzed using frequency and percentage. Frequencies, percentage distribution, mean, standard deviation, paired ‘t’ test and unpaired ‘t’ test was used. Chi-square test was done to determine the association with the posttest scores of oral mucositis among chemotherapy patients with their demographic variables.
Finding Related to Demographic Data
In this study overall the highest percentage in the demographic data including the Age group 60% (>60years), Gender 70% (Male), Income 70% (Rs 3000-6000), 60% belong to nuclear family, 70% patients had 3-6 days duration for oral mucositis, 60% of patients had epidermoid cancer.
Table 1, showed that in control group pre test 70% of patients had moderate oral mucositis, 30% of patients had mild oral mucositis and similar percentage in post test (50%) had moderate and severe mucositis respectively. It seems that there is difference in pre and post test scores without intervention. In experimental group pre test 10% of patients had mild oral mucositis, 40% had moderate oral mucositis and 50% had severe oral mucositis whereas in post test 70% of them had mild oral mucositis and only 30% of them had moderate oral mucositis. It showed that cryotherapy was effective among chemotherapy patients.
Table1: Frequency, Percentage Distribution of Pre and Post Test Scores of Oral Mucositis among Chemotherapy Patients in Control and Experimental Group
| Level of oral Mucositis | Control group (n1 = 10) | Experimental group (n2 = 10) | ||||||
| Pre test | Post test | Pre test | Post test | |||||
| Frequency | % | Frequency | % | Frequency | % | Frequency | % | |
| Mild | 3 | 30 | - | - | 1 | 10 | 7 | 70 |
| Moderate | 7 | 70 | 5 | 50 | 4 | 40 | 3 | 30 |
| Severe | - | - | 5 | 50 | 5 | 50 | - | - |
Comparison of Mean, SD of control group pre and posttest scores reveals that, in pretest the mean score was 6.4 and posttest mean score was 8.3. It depicts that without intervention of cryotherapy on oral Mucosities was not effective. Comparison of Mean of experimental group pre and posttest scores reveals that, in pretest the mean score was 8.1 and posttest mean score was 4. It depicts that cryotherapy on oral Mucositis was effective among chemotherapy patients. In Paired ‘t’ test (12.86) and Unpaired ‘t’ test (10.56) the ‘t’ value (0.65) was high, hence it seems that cryotherapy on oral mucositis was effective among chemotherapy patients and chi-square test showed no association between post test scores with their demographic variables of both the groups of chemotherapy patients (Table 2).
Table 2: Comparison of Mean, SD, Paired ‘T’ Test and Unpaired ‘T’ Test of Experimental and Control Group Pre and Posttest Scores
Variable | Group | Mean SD | Significance Paired ‘t’ test | Significance Unpaired ‘t’ test | ||
Experimental group (n1) pre-posttest | Control group (n2) pre-post test | Experimental group posttest | Control group posttest | |||
Oral Mucositis | Experimental pretest | 8.1 2.42 | t = 12.86 p <0.05 | t = 2.00 P >0.05 | Mean = 4 | Mean = 8.3 |
Experimental post test | 4 1.56 | t = 10.56 p <0.05 | ||||
Control pretest | 6.4 1.96 | |||||
Control posttest | 8.3 1.88 | |||||
N = 20 (n1=10, n2=10)
Nursing Implications
This method can be used in various settings
This technique can be used to demonstrate the care givers of patients
This technique can be used to the nursing personnel working in hospital for reinforcing their practices
Nursing educator should educate the nursing professionals to use this cryotherapy and find out the effectiveness
The researcher educates the family members to follow this procedure for prevention of oral infections
Recommendations
An experimental study would be undertaken without control group
A large scale study can be carried out to generalize the findings
The findings of the study, similar percentage (60%) of patients were in the age group of >60 years in both the groups. Most of them were both sex and belongs to nuclear family, educated and had epidermoid cancer
Cryotherapy is highly effective on oral mucositis among chemotherapy patients
Highly significant effectiveness was found between control and experimental group in the all areas of oral mucositis
No significant association was observed between post test scores with their demographic variables of both the groups of chemotherapy patients
Svanberg, A. et al. “Oral cryotherapy reduces mucositis and improves nutrition: A randomized controlled trial.” Journal of Clinical Nursing, vol. 19, no. 15–16, 2010, pp. 2146–2151. https://doi.org/10.1111/j.1365-2702.2009.03083.x
Inagaki, N. et al. “Cryotherapy Is useful and safe in the prevention of oral mucositis after high dose melphalan.” Nursing Times, 2006, pp. 123–321.
Svanberg, A. et al. “Oral cryotherapy reduces mucositis and opioid use after myeloablative therapy: A randomized controlled trial.” Supportive Care in Cancer, vol. 15, no. 10, 2007, pp. 1155–1161. https://doi.org/10.1007/s00520-007-0245-8
Castro, G. “Oral mucositis prevention by low level laser therapy in head and neck cancer patients submitted to concurrent chemoradiation.” 2009, pp. 112–126.
Balan, S.K. et al. “Radiation induced oral mucositis.” 2009, vol. 15, no. 2, pp. 95–102.