Episiotomy is the most common surgical incision of the perineum in obstetrical
procedure. Approximately 33% of women with vaginal delivery had episiotomy in
2000 (American College of Obstetricians-Gynecologists, 2006).
However, the prevalence of episiotomy is not the same in different countries.
Asian race are presumed to have smaller and tighter perineum so the routine
episiotomy may reduce the risk of perineal tearing during delivery (Lam
et al., 2006). Medio lateral episiotomy is usually preferred from
a midline episiotomy because of the risk of the third or fourth degree tear
and also because of short perineum in Asian race (Lam
et al., 2006; Cunningham et al., 2005).
Like any other surgical incision, episiotomy results in some discomforts for
most of postpartum patients (Hill, 1989). Studies reported
10% of women experienced pain for >2 months after spontaneous vaginal delivery
and the rate rose to 30% for those who had an assistant vaginal birth (Punasundri
et al., 2006; Mann, 1996). In Iran the prevalence
of episiotomy is much higher than that supported by scientific evidence and
the rate of mediolateral episiotomy is higher than median episiotomy. So, it
seems that the prevalence of surgical complications is also higher in Iranian
women. One recent study revealed that episiotomy was performed in 97.3% of 510
primiparous women who had vaginal delivery in Tehran (Shojaei
et al., 2009). Currently, in most parts of Iran the patient is prescribed
a standard regime of oral analgesics to taken 3 times daily and also bath water
sitz is suggested with Betadine 10% as an additive for duration of 30 min twice
Zahravi showed that there was no significant difference between the betadine
and water groups in wound healing (Tork et al., 2002).
Cooper demonstrated in their study that povidone-iodin with a twentieth of typical
concentration can inhibit function of fibroblasts and lymphocytes (Cooper
et al., 1991). Cooling for short time has been used for relieving
pain of localized tissue trauma for many years (East et
al., 2007). Little research has been done to evaluate the effect of
topical application of perineal cold gel pads as an alternative way of treatment
for reduction of perineal discomforts (Punasundri et
al., 2006). According to above concerns, this study was undertaken to
compare the effectiveness of perineal cold gel pad versus the routine practical
program of warm bath sitz with betadine as an additive.
MATERIALS AND METHODS
Methodology: A randomized control clinical trial method was carried out to evaluate the effects of relieving discomforts of cold gel pads to the perineum of the Iranian primiparous mothers.
Sample and setting: The project was approved by the Ethics in Research
Committee of Iran University of Medical Sciences. The study conducted in the
postpartum ward and clinic of Kamali Hospital in Karaj. Over a period of 4 months
(from July-November 2009) with a convenience sample of 60 primiparous mothers
who had term (37-42 weeks), cephalic vaginal delivery and selected with random
allocation method. All the mothers had experienced episiotomy and they were
able to cooperate with instructions period. Entrance criteria was included single
tone vaginal deliveries with episiotomy and without any tearing, operative delivery,
systematic chronic diseases and psychological problems, allergies, contextual
diseases, eclampsia and preclampsia during pregnancy, PROM more than 24 h, prolonged
labor and precipitate labor, addiction, volvo vaginitis and hematoma in perineum
during 12 h after delivery. All participants who agreed with the study procedures
and voluntarily agreed to participate signed the free and informed consent form.
By using a table of random numbers, 60 subjected were randomly allocated to
one of two treatment groups. There were no differences between two groups based
on episiotomy type, repair method, string type, analgesic dosage before and
after stitching, operating labor. Subjects in the control group were following
the routine practical program of taking warm sitz bath twice daily for 30 min
with 10 mL betadine 10% as an additive to 4 L water while those in experimental
group were given a reusable cold gel pads, they had to chart the frequency of
their usage according to their pain. They had use it each time for 20 min. Intensity
pain and discomfort of episiotomy was assessed by VAS and REEDA scales, respectively.
Pain intensity and discomfort assessment were done before intervention during
the first 4 h after episiotomy as a basic assessment and after pain relief intervention
of intervals of 4, 12 h and 5 days after episiotomy. Healing episiotomy was
recorded using a REEDA scale at 5 days after episiotomy. All analgesics were
consumed by the subjects recorded. Subjects in both groups were routinely allowed
to take mefenamic acid capsules 3 times during the first 12 h after episiotomy
and they were allowed to consume analgesics when is needed at home if consumption
of analgesics were mre than routine program that they were omitted. Individuals
who did not attend for examination or presented any sign of allergy or infection
were excluded. All subjects in interventional group were asked to use gel pads
whenever they had pain and chart the frequency of their daily usage of gel pads
during 5 days. Data analysis was done by SPSS software version 14.00 for Windows
using t-test and χ2. The significance level was set at (α
According to obtained results there wasnt a significant difference between both groups for their demographic information such as age, education, economical status, job experience and obstetrical and neonatal factors including: The length of episiotomy, duration of each labor stage (first to third), the number of superficial stitches, mothers body mass index 5 days after episiotomy, neonatal head circumference and also after episiotomy factors such as mothers highest status for breast feeding and time for commencing daily activities after delivery (p>0.005) (Table 1).
Pain score before intervention: There were not any similarities in intensity
of pain in the process of research thus basic assessment before intervention
was done to estimate the intensity of pain both groups. The mean level for the
intensity of the pain was (4.90±1.56) for gel pad group and it was (4.47±1.30)
for control group and there wasnt a significant difference between two
groups (p = 0.29).
|| Demographic information, obstetrical and neonatal and after
post partum factors
|| Mean level of analgesics consumption after delivery
|The mean difference is significant at the 0.05 level
Pain score after intervention: The mean for the intensity of the pain 4 h after intervention in experimental group was 3.20±1.58 and it was 4.23±1.59 in control group that indicated a significant difference between groups (p = 0.014). In addition, a significant difference between the intensity of the pain of the mean level was shown 12 h and 5 days after episiotomy. the intensity of the pain of the mean level was (3.17±1.64) in gel pad users and it was 4.53±1.56 in control group 12 h after episiotomy (p = 0.002).
The intensity of the pain of the mean level for experimental group was 2.20±1.62 while it was 4.60±1.79 for control group 5 days after episiotomy (p = 0.000). Moreover, 70% of subjects in experimental group (gel pad users) hadnt taken analgesics while 33.3% participants in control group hadnt consumed analgesics 4 days after episiotomy and due to this a significant difference was shown between the analgesics consumption of groups 4 days after episiotomy (p = 0.007). There was a significant difference between the mean level of analgesics 2-5 days after delivery (p<0.05) (Table 2).
According to the results, 50% of subjects used gel pads 1-2 times in the 1st day. However, the usage of gel pads increased to 3-4 times in 56.7% of subjects in the 2nd day and 53.3% of participants in the 3rd day after episiotomy.
The rate of using gel pads dropped again to 1-2 times a day in 53.3% subjects in the 4th day after episiotomy and 53.3% participants in the 5th day after birth.
The mean and standard deviation for the REEDA scores before intervention in each group were (4.67±1.37), gel pad group and (4.47±1.54), betadine group. There wasnt a significant difference between two groups (p = 0.59).
There were no statistically significant differences detected in redness, edema, ecchymosis, discharge and approximation before intervention (Table 3).
The use of cold gel pads resulted in statistically significant differences
detected in perineal edema, ecchymosis, approximation at 5 days after episiotomy,
compared with use of betadine.
||Comparison of REEDA (Redness, Edema, Ecchymosis, Discharge
and Approximation) scales between two groups before intervention
||Comparison of REEDA (Redness, Edema, Ecchymosis, Discharge
and Approximation) scales between two groups at 5 days after episiotomy
While there were no differences detected in redness and discharge between
the two groups. However, the REEDA scale was significantly low in the experimental
group at 5 days after episiotomy (p = 0.000) (Table 4).
The primary reason of perineal pain is bruising of the perineum followed by
episiotomy. Perineal trauma causes pain and discomfort and this can dominate
the experience of mother hood (Sleep, 1995; Punasundri
et al., 2006). In addition, pain can cause decreased mobility and
discomfort with passing urine or faeces and it has many negative impacts on
the womens ability to care for their newborns also their ability for breast
feeding and attending to their babys need would decrease significantly
(Cunningham et al., 2005; Kropp
et al., 2005; Sultan and Thakar, 2002). Furthermore,
studies have evidenced that episiotomy results in more pain, sexual disfunction
and infection than spontaneous perineal tearing and this pain has negative affections
on the womens health in the postpartum period (Araujo
and Oliveira, 2008; Larsson et al., 1991).
Perineal pain in mediolateral and medial episiotomy is higher than spontaneous
tearing (Walsh, 2001). Study about the episiotomy rates
around the world showed that this surgery ranged from 9.7% (worthern Europe-Sweden)
to 96.2% (South Africa-Ecuador) with the lowest episiotomy rates in English-speaking
countries (North America-Canada: 23.8% and United states 32.7%) and it remained
very high in many countries (centered south-America like Brazil: 94.2%, South
Aferica-63.3% and Asia like China 82%) (Graham et al.,
2005). Recent study in Greece revealed that the highest portion of obstetricians
prefer to do mediolateral and lateral episiotomies for normal and operative
vaginal birth (Grigoriadis et al., 2009). According
to the importance of women health promotion and due to previous investigations
revealing the higher intensity of pain in mediolateral episiotomy and high prevalence
of mediolateral episiotomy in Iran, there is a special need in finding a new
way of relieving pain. Besides, there are very little formal investigations
on prevention and relieving of perineal pain after episiotomy following the
Cold therapy has been shown to attenuate the level of pain by numbing the superficial
tissue surrounding the wound through its action on local nerve fibers and by
decreasing the levels of perineal edema and pain (Steen
et al., 2000). Decreasing the temperature of soft tissue by 10-15°C
by applying a local treatment reduces the metabolism of the cells and also decrease
the oxygen needs of the tissue. So, it causes constriction of the peripheral
blood vessels. The heat activated receptors are known to play a significant
role in inflammation-related pain and the pain relives by cooling effectively
(East et al., 2007; Kichko
and Reeh, 2004; Reid, 2005). There is a tendency
to replace non medicinal and non invasive interventions in spite of chemical
and medical substances (Paterson et al., 2004).
The study showed that applying gel pads after episiotomy can be a good treatment
for relieving pain. However, another randomized control trials between 120 subjects
for evaluating the effectiveness of icepacks and epifoams with cooling gel pads
on relieving postnatal perineal pain showed no statistical significant difference
between groups (Steen et al., 2000). We suggest
that this can be related to differences between the tissue constructions that
may be connected to different races of subjects and also the differences between
pariety of the participants and type of episiotomy and also the number of participants.
In addition, less oral analgesic consumption in the experimental group (gel
pads users) might be another reason that supports the efficiency of cold gel
pads on reliving pain. Further studies by considering different nations are
recommended to make the proof for the results of the experiment.
According to above concerns and results from this research and previous publications and due to the importance of womens health promotion especially during post partum period for making better quality of life for both mothers and their newborns. So, applying cold gel pads is an effective non-invasive method of reliving discomforts.
Funds were provided for this project through the Research assistant of Iran University of Medical Sciences. Additionally, the study would not have been possible without the co-operation of all the clients who participated.