Effect of Aloe Vera Gel versus Normal Saline on Pain Relief and Healing Process of Episiotomy

Introduction: Spontaneous or episiotomy-induced damage to the genital organs during delivery affects the quality of active labor, especially among primiparous women. It is frequently observed during delivery and can have detrimental effects on a mother’s health and quality of life. Aim of the study to determine the effect of Aloe Vera gel versus normal saline on pain relieve and healing process of episiotomy. Materials and method: Design : A comparative quasi-experimental research design was utilized. Subjects: A convenience study subject of (120) women were selected from EL-Shatby Maternity University Hospital. Tools: Four tools were used by the researchers to collect the necessary data: Tool I: basic data structured interview schedule, Tool II: Pain Intensity Visual Analogue Scale (VAS), Tool III: Wound Healing REEDA Scale and Tool IV: Bacteriological Wound Study. Results : There was a statistically significant differences between both groups in relation to perineal pain intensity after 10 postnatal days (X 2 = 7.937, p = 0.005). On the 10 th postpartum day, the entire Aloe Vera group did achieve complete healing of episiotomy wound compared to 80% of the normal saline group. There was a statistically significant difference between both groups (p < 0.0001). Conclusion : it could be concluded that the application of Aloe Vera gel was more effective on wound healing and perineal pain than normal saline among postnatal women with episiotomy. Moreover the growth of the isolated organisms among the episiotomy wound treated with the Aloe Vera gel were less than among those treated with normal saline. in Aloe Vera which inactivates bradykinin which is the powerful factor of acute inflammatory pain. Magnesium lactate in Aloe Vera gel is used as anti-itching and analgesic drug by inhibiting histidinedecarboxylase which controls conversion of histidine to histamine in mast cells. Yagi, A (2003) , Maenthaisong, R,. et al (2007) several studies regarding the application of Aloe Vera gel. First, Varaei et al (2017) who had study titled the effect of Aloe Vera gel and Nitrofurazone on dressing related pain of superficial burn wounds in Iran . They reported that dressing pain intensity decreased significantly during a 72-hour period in both areas (p=0.001), but Aloe vera gel could reduce pain more and faster than nitrofurazone. Second, a study was done by Alamolhoda H et al (2014) about "Effects of Aloe Vera gel on breast fissures in breastfeeding women in Iran . They concluded that Aloe Vera gel can improve breast fissures. Third, a study conducted by Sabzaligol,M. et al,(2014 ) who conducted a randomized controlled clinical trial to assess the effect of Aloe Vera gel on perineal pain & wound healing after episiotomy in Iran. They concluded that Aloe Vera gel alleviated the perineal pain after episiotomy. Fourth, Eshghi F, et.al (2010) . They had investigated effects of Aloe Vera Cream on Post hemorrhoidectomy pain and wound their results had indicated that patients in the topical group had significantly less post-operative pain at hours 12,24,48 hrs post-surgery (p<0.001).Wound healing at the end of second postoperative week was significantly greater in Aloe Vera group compared with placebo group(p<0.001).Patients needed fewer analgesics post operatively(p<0.001).The study concluded that application of Aloe Vera cream on the surgical site is effective in reducing postoperative pain study group group2 perineal Aloe study perineal ecchymosis,

reported pain on the first and seventh postpartum days, respectively. Studies also revealed delayed perineal healing in women with episiotomy ;unhealed wound can prolong perineal pain which can exacerbate wound healing . Perineal pain resulting from episiotomy has always been a stressful problem for nulliparous women, which exerts a negative effect on their performance and first experience of becoming mother. The consequences of perineal pain include insomnia, fatigue, disturbance, anxiety, lack of attention to health education provided by caregivers, delay in joining the mother to her neonate (even sometimes prevention of emotional relationship between the mother and neonate), maternal immobility, formation of a sense of inability to look after the newborn, improper placement during breast-feeding, and in severe cases, deep vein thrombosis (Golezar, S.,et.al

2016, Apurva et al., 2016),
Many measures have been recommended to reduce perineal pain and improve wound haeling, such as observing the perineal hygiene, keeping the wound dry, and using various pharmacological and nonpharmacological treatments. The pharmacological treatments to alleviate perineal pain are acetaminophen, mefenamic acid, lidocaine gel, and sodium diclofenac suppository. The nurse should be aware of the effective treatment of episiotomy wound healing which can reduce the suffering of mothers and enhance healing. Steen,

M.et.al,. (2016)
Normal saline (0.9%) is the favored wound cleansing solution because it is an isotonic solution and does not interfere with the normal healing process, damage tissue, cause sensitization or allergies or alter the normal bacterial flora of the skin (which would possibly allow the growth of more virulent organisms). Use of normal saline would be cost effective, easy to prepare, readily available and least damaging agent, as the healing occurs without local antibiotics or disinfectants. It does not alter the normal bacterial flora of the skin and has no effect on blood flow in capillaries. In addition it helps to remove things that can irritate the underlying tissue as well as help to wash out bacteria. It relieves redness and hastens the healing of episiotomy. Eduardo S,et.al.
(2016), Attarha ,M. et. al( 2014). A comparative study to assess the effects of normal saline with other solution for wound cleansing. The study had 11 trials which included 310 postnatal mothers. The findings suggest that 62.9% of mothers treated with normal saline had good healing. The 38% of mothers treated with other solutions had got skin irritation. The result shown that normal saline is effective in reducing the infection rate than any other solutions. The study concluded that normal saline can be used as a healing agent which not interfere the normal healing process. Fernandez, R., Griffiths Russia (2012) Furthermore Non-pharmacological treatments in this regard include cryotherapy, laser therapy, electrical stimulation, acupuncture, and pelvic floor exercises. Among the studies examining the effects of herbal medicines on wound healing and episiotomy pain based on the mean score of pain recovery, the use of lavender, olive, turmeric, cryotherapy and Aloe vera, were reported as the most effective methods in wound healing and alleviation of episiotomy pain . Delaram M et.al (2014), Shahrahmani H (2016). Aloe Vera is a medicinal plant from 1500 years BC in many countries, including Greece, China, Mexico, which had been traditionally used for centuries as a local medicine for various diseases and skin lesions . Aloe Vera is an herbaceous and perennial plant with long thick fleshy leaves that belongs to the Liliaceae family and is similar to cactus in appearance. Malek Hosseini A et al (2013) So far, 75 known compounds are found in Aloe Vera which contains 20 minerals, 20 amino acids, vitamins and water. Among them copper, iron, calcium, zinc, manganese, sodium , potassium, salicylic acid, vitamins A, B, C, E, B12 and folic acid can be pointed out. Sahu PK et.al (2013) Journal of Health, Medicine andNursing www.iiste.org ISSN 2422-8419 An International Peer-reviewed Journal Vol.70, 2020 In vitro studies and in studies that have been conducted on living organisms it has been shown that Aloe Vera inhibits thromboxane)an inhibitor of wound healing), helps healing and reduces inflammation . Magnesium lactate in Aloe Vera gel prevents the reaction of histamine, which causes itching and irritation to skin. Aloe Vera reduces the adhesion of leukocytes, increases the levels of IL-10 and decreases the levels of TNF alpha, so it is effective in inhibiting inflammatory reactions. Its regenerative property is related to a compound called Glucomannan which is rich in polysaccharides such as mannose that effects on receptors of the fibroblast growth factor and stimulates its activity and proliferation and increases collagen production. Aloe Vera gel not only increases the amount of collagen in wounds, but also changes the composition of collagen by increasing the collagen crosslinking and thereby accelerates healing of the wound. Tafazolie  Studies show that since 99% of Aloe Vera gel is water, it can increase the flexibility of skin and reduce its fragility Also, the muco-polysaccharides along with amino acids and zinc in Aloe Vera help skin integrity, retain its moisture, reduce erythema and help prevent skin ulcers Many studies have shown that using Aloe Vera to treat various wounds such as psoriasis, mouth ulcers, diabetic ulcers herpes and bed sores has had positive effects.

Dat AD et al(2012)
Given that the care of episiotomy is one of the important and challenging issues in medicine and nursing and prevention of its complications is one of the main tasks of nurses which is also cost-effective, on the other hand, the use of traditional medicine and herbal plants is one of the ways to prevent episiotomy's side effect so this study intends to investigate the effect of Aloe Vera gel versus saline on pain relieve and healing process of episiotomy. Such information may be added to the nurses' evidence-based practices during postpartum care. Ultimately, this will improve puerperal women's health and positively influence maternal morbidity and mortality.
1.1 Aim of the study: the study aims to determine the effect of Aloe Vera gel versus saline on pain relieve and healing process of episiotomy

Research Hypotheses:
 Postnatal women who perform perineal wash with saline exhibit less perineal pain and more positive signs of episiotomy healing than those who do it with Aloe Vera Gel rubbing.
 Postnatal women who perform perineal rubbing with Aloe Vera Gel represent less perineal pain and more positive signs of episiotomy healing than those who do it with saline washing.

MATERIAL
Research Design: A comparative quasi-experimental research design was utilized.

Setting:
The study was carried out at the postnatal unit of EL-Shatby Maternity University Hospital in Alexandria. This particular setting was chosen because episiotomy is routinely performed to all primiparae attending for delivery.
Subjects: According to EL-Shatby Maternity University Hospital statistical center, 2017, flow rate of the laboring women undergo vaginal delivery were 1100 women at the end of December 2017. Ten percent of flow rate (110 women) was selected. Considering dropout during follow-up, the researchers added 10% from the 110 Journal of Health, Medicine and Nursing www.iiste.org ISSN 2422-8419 An International Peer-reviewed Journal Vol.70, 2020 women. Thus the total sample size was 120 parturient women; A convenience study subject of (120) women were selected from the previously mentioned setting according to the following inclusion criteria: primiparae immediately after childbirth, had a normal vaginal delivery with episiotomy, complaining of perineal discomfort (pain}, does not use any pain relieving drug and free from diseases or health problems which may affect the healing process such as diabetes.
The selected subjects were equally divided into two experimental groups.
 Study group (1) included 60 women who were instructed to apply Aloe Vera Gel as local episiotomy treatment.
 Study group (2) comprised 60 women who were advised to irrigated episiotomy wounds with 0.9% normal saline solution in measured quantities

Tools of data collection
Four tools were used by the researchers to collect the necessary data:-Tool I: Basic Data Structured Interview Schedule: It was developed by the researchers to collect the subject's socio-demographic characteristics such as: age, level of education, occupation…etc.
Tool II: Pain Intensity Visual Analogue Scale (VAS): It was adopted by Melzac and Ketz (1994) to assess the subjective level of pain severity over or near the wound site. It is a standardized linear scale that ranges from 0-10 corresponding to the degree of pain intensity. Where 0 indicates no pain and 10 indicates the worst pain.
Tool III: Wound Healing REEDA Scale: It was developed by Davidson,N(1974) and then reconstructed by Hill ,P (1990). This tool was used to assess the episiotomy healing process. It appraises the perineum for 5 healing signs: Redness, Edema, Ecchymosis, Discharge and Approximation. Thus the tool came to be known as REEDA scale. Each category is assessed and a number that ranged from 0 to 3 is assigned.

Tools development:
Tool I was developed by the researchers after extensive review of recent and related literature while tool II and tool III were adopted. The content validity of the developed tools was tested by a jury of five expertise's' in the obstetrics and gynecological nursing to ascertain its relevance and completeness. Reliability of the tool (II and III) was assessed by using Cronbach's Alpha coefficient test. The tool consisted of relatively homogeneous items as indicated by the high reliability.
Internal consistency of the tools were 0.7604 & 0.8168.

2.2.3.
Aloe Vera fresh Gel was prepared by specialist, Prof. Dr. Salma Eldreer, Professor of plant & microbiology, faculty of science. It was extracted from Natural cactus. The cactus leaf is placed longitudinally or vertically. Then cut the paper with the knife and strip the paper of liquid substances the resides on the first layer of the paper because it can cause obvious skin burns if applied directly to the skin, then scraped the Aloe Vera gel with a spoon. Place the gel in a sterilized, clean glass jar. It remains valid for use for a short period ranging from one to four weeks in the refrigerator. He provided the researchers with a certificate for insurance of safety use of Gel.

Pilot study:
A pilot study was carried out on 12 women (who were excluded from the sample) to ascertain the clarity and the applicability of the tools then the necessary changes were undertaken.

Selection of the study subjects:
The researchers selected the women who fulfilled the criteria from the postnatal unit of EL-Shatby Maternity University Hospital in Alexandria. The researchers explained the purpose of the study to every woman, and then her consent to participate in the study was obtained.
Each interview was conducted individually and in total privacy to assure that information to be obtained will be confidential and will be used only for research purposes.

Procedure of the study:
The study proceeded as follows:  All study subjects were individually interviewed by the researchers within 4-6 hours after childbirth to collect the basic data (tool I), episiotomy pain intensity (tool II), as well as to assess the episiotomy wound (tool III). After the assessment the researchers did perform perineal care for each subject. Then the researchers applied the two methods (Aloe Vera gel , and Normal saline ) of treatments :  For study group (1) the researchers rubbed (3cc or 1teaspoons) of Aloe Vera gel for the first time on episiotomy area by disposable glove for training and according to given training, the mother continued using gel every 12 hours. Adequate supply of '' Aloe Vera Gel put in a sterilized, clean glass jar "' for used it twice per day over ten days was provided.
 For study group (2) the researchers irrigated episiotomy wounds with 0.9% normal saline solution (10 cm) for the first time on episiotomy area from forchette to anus by disposable syringe for training and according to given training, the mother continued using normal saline every 12 hours. Adequate supply of 0.9% normal saline (10 cm at each time) for used it twice per day over ten days was provided.
 After washing the area was dried and then a clean dry pad was applied by the woman.  After the procedure each study subject was asked to re-demonstrate the previously mentioned procedure at home two times per day until the tenth postpartum day.
 Follow up: Women of the two groups were instructed to come to the hospital for follow up visits during the morning shift on the 5 th , and 10 th day post-partum, the perineal area was observed for (redness, edema, ecchymosis, approximation of the skin and pain  On the fifth day each study subject came to the hospital during the morning shift.


The researchers had evaluated the episiotomy pain intensity (tool II) and episiotomy wound healing (tool III).


Then the researchers had taken a bacteriological culture through the following procedure:--A sterile glove was applied. Then wound was irrigated thoroughly with a sterile saline solution.
-A sterile swab from a culture collection kit was pressed to the wound with enough pressure to press out fluid from the wound tissue. While gently twirled the swab between the fingers, it was moved from one edge of the wound to the other edge in a zigzag motion. Culture collection/transport kit was labeled with name, date and time of culture.
-Then the swab was immediately transported in the culture medium to the microbiology lab at El Shatby hospital for culturing as quickly as possible.
 On the tenth day each study subject again came to the hospital during the morning shift. The researchers had repeated what occurred in the first visit except performing wound culture.
 The healing process of the episiotomy was assessed and compared among the two study groups to find out the most effective method in dealing with the episiotomy wound.

2.2.7.
Handling and analysis of data: The raw data were coded and transformed into coding sheets. The results were checked. Then, the data were entered into SPSS system files (SPSS package version 11) using personal computer. Output drafts were checked against the revised coded data for typing and spelling mistakes. Finally, analysis and interpretation of data were conducted. The following statistical measures were used:  Descriptive statistics including frequency, distribution, mean, and standard deviation were used to describe different characteristics.
 Kolmogorov -Smirnov test was used to examine the normality of data distribution.  The significance of the results was at the 5% level of significance. 2.2.8. Ethical consideration: for each recruited subject the following issues will be considered: securing the subject's informed written consent after explanation of research purpose, keep anonymity, privacy and right to withdraw at any time as well as assuring confidentiality of the collected data.

RESULTS
According to table (I) the socio-demographic characteristics of both groups were more or less similar without any statistically significant differences. Where, only 20% of both groups were in their thirties. Again about two-fifths (43.3%) of each group were secondary school graduates. Almost all of the Aloe Vera (93.3%) and normal saline (90%) groups were housewives. However, only 3.3% of Aloe Vera Gel group compared to as much as 16.7% of normal saline were rural residents. The percent of subjects from extended families among the Aloe Vera Gel group 43.3% almost double-folded that among the normal saline group 23.3%.  Table (II) exhibits a comparison between perineal pain intensity between Aloe Vera group and normal saline group overtime. Before Intervention ''during the first 24 postnatal hours, there is no a statistically significant difference between both groups regarding perineal pain intensity within 24 hours after delivery. Where, about two-fifths (45 % -48.3%) of Aloe Vera and normal saline groups, respectively, had mild perineal pain. Almost equal proportions (23.3%, 26.7%) of Aloe Vera and the normal saline group did exhibit moderate perineal pain.
Equal proportions (31.7%, 25%) of Aloe Vera and the normal saline group did suffer from severe pain. On 5 th postnatal day, more than one-half (55%) of the Aloe Vera group had mild pain compared to only 36.7% of Journal of Health, Medicine and Nursing www.iiste.org ISSN 2422-8419 An International Peer-reviewed Journal Vol.70, 2020 72 normal saline group. More than two-fifths (45%) of the Aloe Vera gel group did suffer from moderate perineal pain compared to more than one half (55%) of normal saline group. No one (0.00%) of Aloe Vera group did report sever pain compared to more than one-tenth (11.7%) of normal saline group. There was a statistically significant differences between both groups on 5 th postpartum day as regards perineal redness (P=0.0087).However on the 10 th postpartum day, it was observed that the majority (83.3%) of Aloe Vera group had mild perineal pain compared to only 68.3% of normal Saline group. Again only 16.7% of Aloe Vera group did experience moderate pain compared to about one third (31.7%) of normal saline group. There was a statistically significant differences between both groups in relation to perineal pain intensity after 10 postnatal days (X 2 = 6.136, p = 0.046).  73 significant differences between the both groups ( MC P<0.0001) in this respect. Again, on the 10 th postnatal day perineal edema was absent among all Aloe Vera group compared to two-fifths (40%) of normal saline group.
About two-thirds (63.3%) of Aloe Vera group had serum discharge compared to only 6.7% of normal saline group. There was a statistically significant difference between both groups regarding the presence of perineal edema ( MC P<0.0001) , type of discharge from episiotomy wound ( MC P<0.003). Regarding approximation of skin edges, about two-thirds (63.3%) of the Aloe Vera group had closed wound edges compared to only 16.7% of the normal saline group .There was also a statistically significant difference between both groups in this respect ( MC P=0.001). 74 saline group. Meanwhile only13.3% of Aloe Vera group had partial healing compared to more than 53.3% of the normal saline group. There was a statistically significant difference between both groups regarding perineal healing scores (p < 0.0001) during the 5 th postnatal days. On the 10 th postpartum day, all of the Aloe Vera group did achieve complete healing of episiotomy wound compared to 80%of the normal saline group. There was a statistically significant difference between both groups (p < 0.0001)    One research is available in harmony with the current study by Nazari et al (2019) who carried out a study "to evaluate the effect of Aloe Vera gel on perineal pain and wound healing after episiotomy among primiparous women in Iran ". They concluded that the use of Aloe Vera gel, compared to a normal saline solution, reduces pain and accelerates healing of vulvar ulcers without side effects. However, this finding is somewhat in line with several studies regarding the application of Aloe Vera gel. First, Varaei et al (2017) who had study titled the effect of Aloe Vera gel and Nitrofurazone on dressing related pain of superficial burn wounds in Iran. They reported that dressing pain intensity decreased significantly during a 72-hour period in both areas (p=0.001), but Aloe vera gel could reduce pain more and faster than nitrofurazone. Second, a study was done by Alamolhoda The present study indicated that a statistically significant difference was observed in episiotomy healing using REEDA scale among study group 1(Aloe Vera) and study group2 (normal saline) after application, where (P 0.001) .The finding of this study indicated that perineal healing has improved significantly in favorite of Aloe Vera gel among the study group1, where maximum relief of perineal healing, ecchymosis, pain, edema, and redness accomplished among these women on day 10. This is could be explained by the fact that the best-known active components of Aloe Vera gel can hinder thromboxane (an inhibitor of wound healing), progress the wound healing process, and lessen inflammation. Actually, glucomannan and plant growth harmone gibberellins interacts with growth factor receptors of fibrobroblast and stimulate its activity and proliferation for increases collagen synthesis in topical and oral administration of Aloe Vera. The Aloe administration also influence collagen composition (more type III) and increased collagen cross linking for wound contraction and improving breaking strength. It also increases synthesis of hyaluronic acid and dermatan sulfate in the granulation tissue of a healing wound. Magnesium lactate available in the gel can prevent the production of histamine that causes itching and irritation of the skin. Somboonwong, J. et al (2000), Hayes, SM (1999, Reynolds,T(1999 Consequently, such results could be added to the rational of using Aloe Vera Gel for healing. Furthermore, it draws the attention for the need for more researches to be added to the evidence -based background for such practice This result is in accordance with the previously mentioned study. Nazari et al (2019). They concluded that the use of Aloe Vera gel, compared to a normal saline solution accelerates healing of vulvar ulcers without side effects; therefore, it can be beneficial to women. However, this finding is somewhat in line with at least five other researches regarding the application of Aloe Vera gel. In addition, complications of episiotomies include accidental extension into the anal sphincter or rectum, damage to the Bartholin's gland, unsatisfactory anatomic results such as skin tags, asymmetry or excessive narrowing of the introitus. Other complications include pain and oedema , increased blood loss, haematoma, infection and dehiscence. Infection is the invasion of the host by microorganisms, which then multiply in close association with the host's tissues. Bacteria can cause a multitude of different infections, ranging in severity from in apparent to fulminating. Howard, D et.al (1999), Zetterstrom et al (1999) So far, the present study revealed that the growth of isolated organisms was much less among the Aloe Vera group. This result was somewhat similar to on Heggers J P et al. (1995). They did a study about wound healing effects of Aloe Vera gel and other topical antibacterial agents in rat skin. They suggested that Aloe Vera can enhance wound healing process by eliminating bacteria which causes inflammation. Aloe Vera gel was bactericidal against Pseudomonas aeruginosa and acemannan prevented it from adhering to human lung epithelial cells in a monolayer culture, a processed Aloe Vera gel preparation inhibited the growth of fungus Finally, the results of the present study reveals that the two methods for treatment of perineal discomforts namely (Aloe Vera & normal saline) have eventually lead to recovery and relief of signs and symptoms of perineal discomforts and perineal pain. However, Aloe Vera has achieved recovery faster and earlier than normal saline. In addition, Aloe Vera possesses several other properties which probably make it better and safer treatment of choice. It is natural, available, easy to use, less expensive and with minimal adverse effect on the mother.

CONCLUSION
Based on the study findings, it could be concluded that the application of Aloe Vera gel was more effective on wound healing and perineal pain than Saline among postnatal women with episiotomy. Moreover the growth of the isolated organisms among the episiotomy wound treated with the Aloe Vera gel were less than among those treated with Saline.

RECOMMENDATIONS
Based on the findings of the present study the following recommendations are suggested: 1. The curricula of basic nursing / midwifery education as well as continuing education could be enriched with , correct , relevant evidence -based information about non-pharmacological management of episiotomy with essential oils.
2. In -service training programs for nurses in postpartum units-about the utilization of non-pharmacological approaches is recommended 3. Further researches are also recommended:  The effect of Aloe Vera gel on other pains encountered during the reproductive life.
 Assessment of postnatal women's satisfaction with the use of non-pharmacological techniques for management of episiotomy pain and healing  Replication of the present study at different sittings and among different subjects.