The Effect of Designed Protocol of Care on the Outcomes of Postpartum Perineal Trauma: a Randomized Controlled Trial (RCT)
Phase: NA
Conditions: Perineal Injury
Sponsor: Asmaa Abdallah Ahmed Hussein

ID: Asmaa Abdallah Ahmed Hussein 
Document title: Designed Protocol of Care for Postpartum 
Perineal Trauma 
Document date: 17th of May /2023 
NCT number: NCT05268276 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
The Effect of Designed Protocol of Care on the Outcomes of Postpartum Perineal 
Trauma: a Randomized Controlled Trial (RCT) 
By
 
Asmaa Abdallah Ahmed Hussein
 
(MSc.  Nursing)
 
Dissertation proposal
 
Submitted for Partial Fulfillment of the Requirements of the 
 
Doctoral Degree in Midwifery Nursing
 
 
   Advisors  
            Dr. Shadia Abdel Kader Hassan 
           Professor of Maternal & Newborn Health  
Nursing 
Faculty of Nursing 
Cairo University 
 
Dr. Yousria Ahmed El Sayed 
Professor of Maternal & Newborn Health 
Nursing 
Faculty of Nursing 
Cairo University 
Faculty of Nursing 
Cairo University 
2021 
 
  
 

 
 
 
 
 
 
Introduction 
 
 
 
Worldwide, more than 85% of women giving a normal birth experience perineal 
trauma spontaneous perineal tear, episiotomy or both. The incidence of spontaneous tears 
decreases in subsequent births, from 90.4% of ﬁrst-birth women to 68.8% for multipara 
giving normal birth. Perineal trauma is defined as any injury to the perineum during 
childbirth which occurs spontaneously or intentionally through a surgical incision 
(episiotomy). Anterior perineal trauma includes injury to the labia, anterior vaginal wall, 
urethra and clitoris, and is usually associated with less mild morbidity rate while posterior 
perineal trauma includes injury to the posterior vaginal wall, perineal muscles and anal 
sphincter. During birth, the majority of the perineum traumas are on the posterior vaginal 
wall extending to the anus (Sotunsa, Ari, Leslie, & Ari, 2019). 
 
 
 
 
Spontaneous perineal trauma (tears) during normal birth is classiﬁed into four 
degrees. In the ﬁrst degree, only the skin of the perineum is injured, the muscles are intact. 
The second degree of perineal trauma involves tearing of the muscles of the perineum 
without affecting the anal sphincter. The third degree of injury involves tearing of the anal 
sphincter. While, in the fourth degree of perineum tear, there is a complex rupture of the 
anal sphincter which includes the external and the internal anal sphincter and the anal 
epithelium (East, Dorward, Whale, & Liu, 2020). 
 
 
 
 
Perineal trauma may lead to short and long-term physical, physiological, social and 
psychological complications. In the immediate postpartum period the complications include 
pain, swelling, redness in the area of the surgical wound, dehiscence, hematoma, trauma of 
the urethra and the anal sphincter. Long-term complications include chronic infections, 
dyspareunia, anorectal dysfunction, faecal incontinence, urinary incontinence or retention.  
Also, 23% – 43% of women continue to experience pain and discomfort in 10 – 12 

 
 
 
 
 
 
postpartum days and 7% – 10% of women have long-term pain 3 – 18 months after birth, 
23% of women experience surface dyspareunia in the 3rd month, 3% - 10% report of faecal 
incontinence, and 24% report of urinary problems (Ibrahim, Elgzar, & Hassan, 2017 & 
Vasileva, Strashilov, &Yordanov, 2019).  
 
 
 
 
Moreover, social and psychological complications associated with perineal trauma 
affect the woman’s ability to care for her new baby and cope with the daily tasks of 
motherhood and they have a significant impact on daily activities as walking, defecation, 
urination, self-care, breastfeeding, interfere with the women’s sleep, rest, and appetite.  
These difficulties can cooperate towards negative, painful delivery experiences and may 
cause mental disorders as postpartum depression. They also change the mother’s attitude 
towards her neonate and affect her sexual function (Mohamed, &El-Nagger, 2017). 
 
 
 
 
In addition, delayed healing of postpartum perineal sutures is a significant health 
problem that can cause morbidity such as pathologic complication like hematoma, 
inflammation or even infection. So, acceleration of perineal wound healing during the 
puerperium is desirable to avoid postpartum women from the dangers of infection or 
physiological complaints, particular observations and treatments are needed to ensure that 
the area heals quickly and easily (Magoga et al, 2019). 
 
 
 
 
Several pharmacological and non-pharmacological treatments have been investigated 
for healing of perineal trauma after vaginal delivery. Traditionally, oral analgesics (non 
steroidal   anti inflammatory agents), local anesthetics (cold and warm sitz baths, lidocaine 
gel 2%) are used in postpartum care to alleviate perineal trauma. Currently several non-
pharmacological therapies are of great importance for the treatment of perineal trauma since 
they do not cause systemic side effects, such as drowsiness, irritability and  changes in the 

 
 
 
 
 
 
composition of breast milk (Webb et al, 2019). 
 
Non pharmacological interventions include early cold therapy (ice gel pad or ice 
pack) application, later performance of pelvic floor exercises (Kegel exercises) and 
application of perineal warm compresses or warm sitz bath. These interventions should be 
started immediately after delivery at early postpartum period by applying cold therapy to 
perineal trauma such as ice gel pad as it helps to reduce inflammation, the production of 
cellular debris, edema, hematoma development, spasticity, muscle spindle activity, and nerve 
transmissions, it also increases the release of endorphins and stimulates the repair process. 
The application of ice gel pad should be continued till 24 hours after delivery to decrease 
perineal pain (Filipinni et al, 2019). 
 
Derya, Ergul, Senol, & Aslan, (2017) in their study about the effect of cold 
application to the perineum on pain relief after vaginal birth reported that the application of 
cold gel pad to the perineum relieved perineal pain, increased postpartum comfort and 
decreased the pain felt by the women during the recovery and daily activities  especially 
urination, infant care and breastfeeding. This is consistent with the study that was conducted 
by El-Saidy, Abo Shady, & Soliman, (2018) to test  the effect of applying crushed ice gel 
pads on episiotomy pain and wound healing among postpartum primiparous women and 
reported that women who applied the crushed ice gel pad on episiotomy during early 
postpartum period experienced a lower level of episiotomy pain, had good episiotomy 
wound healing and had better ability to perform daily living activities during the posttest 
than the control group.  
Another non pharmacological intervention that should be started from 6 to 12 hours 
after birth when the patient feels ready is pelvic floor exercises (Kegel exercises). Many 
researchers have emphasized the potency of these exercises during the time of postpartum. 

 
 
 
 
 
 
Advantages of these exercises are that they promote the healing of any tears or episiotomies 
by increasing blood and oxygen flow to the tissue, facilitate flexibility of the tissue, reduce 
edema, relieve the pressure on the incision and the surrounding tissue and might help with 
pain or tenderness due to scarring. They also help to regain bladder control and strengthen 
pelvic floor muscles. These exercises should be performed till one week postpartum 
(Mohammed, Mahmoud, & Abd Elhafeez,   2018; Farrag, Eswi, &Badran, 2016). 
 
Khusniyati, &Purwati, (2018) in their study reported that Kegel exercises are 
recommended  from six hours postpartum and till one week to help accelerate wound 
healing, this is confirmed by other study that was conducted to examine the effect of 
postnatal Kegel exercises on episiotomy pain and wound healing and revealed that  
practicing  postnatal pelvic floor exercises (Kegel exercises)  had a significant effect in 
decreasing perineal pain, accelerating healing of the incision and decreaseing postpartum 
pain associated with movement ,defecation and urination (Farrag, Eswi, & Badran, 2016). In 
addition, after 48 hours of birth and till one week warm compresses for perineal trauma 
should be done as it helps in producing vasodilatation, improving circulation to perineal 
area, improving tissue repair and wound healing, and decreasing incidence of wound 
infection (Khosla, & Pratibha, 2017).  
 
Un fortunately, there is no available guidelines for management of postpartum 
perineal trauma even the guidelines developed by Royal College of Obstetricians and 
Gynecologists ( RCOG, 2015) focused only on the management of third and fourth degree 
perineal tear. Moreover, the Cochrane systematic reviews reported that interventions for the 
management of postpartum perineal trauma are of low quality evidence and the reported 
findings are still conflicting and recommend that further randomized controlled trials are 
needed to support these interventions (RCOG, 2015& East, Dorward, Whale, &Liu, 2020). 

 
 
 
 
 
 
 
In addition, most of the studies have been conducted to test only one intervention or 
compare between two interventions for treatment of perineal trauma but no study tested the 
impact of a designed protocol of care which starts from immediate postpartum and continues 
throughout the first week where a combination of therapies is implemented for treating the 
immediate and sustained perineal trauma. Therefore, the aim of   this study is to test the 
impact of a designed protocol of care that combines several interventions such as perineal 
ice-gel pad application, performance of pelvic floor exercises (Kegel exercises) and perineal 
warm compresses application on the immediate and later outcomes of postpartum perineal 
trauma. 
 
Significance of the study 
From clinical experience, it was observed that many postpartum women with perineal 
trauma experience several short and long-term physical, physiological, social and 
psychological postpartum complications such as severe pain, delayed healing of the wound, 
infection and dyspareunia which may affect the women resumption of function at postpartum 
period and their future choice of the mode of childbirth.  At the same time, there is a lack of 
statistical documentation on the magnitude of this problem.  As well as, there are 
considerable gaps with implementation of evidence to support management of perineal 
trauma at postpartum period. 
 
In this context, serious actions should be taken to accelerate the perineal trauma 
healing and relieve the perineal pain as possible. Most important of these actions is 
immediate postpartum perineal ice gel pad application, later performance of pelvic floor 
exercises (Kegel exercises) and perineal warm compresses. These interventions have a lot of 
advantages as they are not costing, appropriate to postpartum women in many situations, and 

 
 
 
 
 
 
safe. Moreover, these interventions promote, accelerate the healing, decrease the perineal 
pain and facilitate restoration of muscle tone (Farrag, Eswi, & Badran, 2016). 
 
In Egypt, there is a scarce of RCT studies that was conducted in this respect and they 
have contradicting results. Moreover, almost all these studies were conducted to test only 
one intervention or compare between two interventions for treatment of perineal trauma but 
no study tested the impact of a designed protocol of care which starts from immediate 
postpartum and continues throughout the first week where a combination of therapies is 
implemented. So, the results of this study will add to the quality of evidence on the 
effectiveness of postpartum interventions for improving the recovery of postpartum perineal 
trauma. This protocol may be used as guidelines to be implemented for better quality of 
patient care. 
 
Aim of the study 
The aim of the current study is to test the effect of designed protocol of care on the 
outcomes of postpartum perineal trauma. 
Outcome measures 
 
- Primary outcomes: Severity of perineal pain, delayed perineal trauma healing. 
- Secondary outcomes: Occurrence of infection, postpartum difficulty with turning/rolling 
in bed, getting out of bed, sitting, walking, defecation and urination. 
Research Hypotheses 
To fulfill the aim of this study the following research hypothesis is formulated: 
H1: Post partum women with perineal trauma who will receive the designed protocol of care 
will have better perineal trauma outcomes than those who will receive the routine hospital 
care. 

 
 
 
 
 
 
Sub-hypothesis 1: Postpartum women with perineal trauma who will receive the designed 
protocol of care will show better perineal trauma healing than those who will receive the 
routine hospital care. 
Sub-hypothesis 2: Postpartum women with perineal trauma who will receive the designed 
protocol of care will have less perineal pain score than those who will receive the routine 
hospital care.  
 
Conceptual Framework 
      The current study will adopt its concepts from the Gate control theory as well as 
concepts derived from the physiological advantages of immediate postpartum perineal ice 
gel pad application, late postpartum performance of pelvic floor exercises (Kegel exercises) 
and application of perineal warm compresses. 
 
The Gate Control theory proposed by Melzak and Walls (1965) has provided a 
powerful theoretical basis for management of pain associated with perineal trauma.  Pain 
associated with perineal trauma is caused by the presence of a mechanical stimulus due to 
tissue damage so it will stimulate chemical mediators as prostaglandin, histamine, serotonin, 
bradykinin, acetyl choline, P substance, and leukotriene. These substances will be induced 
by nociceptors and transmitted by A-delta and C fibers to the posterior corn in the spinal 
cord where afferent nerves will convey the perception of pain to the brain which increases 
pain sensitivity. 
  
In the current study application of non pharmacological interventions for perineal 
trauma (cold compresses, warm compresses and Kegel exercises) can reduce the release of 
chemical mediators by inhibition of inflammatory process and stimulation of A-beta nerve 
fibers which activate inhibitory neurons and increase endorphin release. Thereby they reduce 

 
 
 
 
 
 
the transmission of pain impulses through A-delta fibers and C nerve fibers (closing the gate) 
in the spinal cord and modulate pain transmission so that pain perception decreases 
(Setyawati, Khasanah, & Suyanto, 2019). 
The following figure represents the Gate Control theory and the role of non pharmacological 
interventions in closing the gate and reducing perception of pain associated with perineal 
trauma (figure 1) 
Also, there are several theoretical physiological advantages for each of these interventions as 
follow (figure 2) 
 
 
 
 
 
     
Perineal warm 
compresses from 48 
hours till one week 
Performance of pelvic floor 
exercises (Kegel exercises) 
from six hours till one week 
Perineal ice gel pad 
Application (1 st 24hours)  
During post partum 
Treatment of perineal trauma 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Operational definition of terms 
1- A designed protocol of care for postpartum perineal trauma: It is a protocol developed 
by the investigator based on systematic reviewed studies and randomized controlled trials. 
The protocol entails a combination of 3 evidence-based therapies for postpartum perineal 
trauma; application of perineal ice gel pad, pelvic floor exercises (Kegel exercises) and 
perineal warm compresses  applied in steps starting from immediate postpartum and 
continues throughout the first week in order to relief immediate and sustained perineal 
trauma.  
• Cause local 
vasoconstriction, reduce 
inflammation, edema, 
hematoma and muscle 
spasm. 
• Decreases the 
temperature of the skin 
and underlying tissue. 
• Produce 
vasodilatation.  
• Increase circulation to 
the wound. 
• Keep perineal area 
clean. 
• Promote healing. 
• Increasing 
blood 
and 
oxygen flow to the tissue. 
• Facilitates flexibility of 
the 
tissue, 
reduces 
swelling, and relieves the 
pressure on the incision. 
• Helps to regain bladder 
control, strengthen pelvic 
floor muscles.
• Reduction of pain experienced 
• Enhance healing of perineal trauma 
• Minimize infection 
• Minimize postpartum difficulty with performing 
functional activities 
• Help reduce pain 
• Stimulate repair 
process 
• Stimulate healing process. 
• Help  further  reduction of 
perineal pain and 
• Decrease infection 
• Promote healing 
• Alleviate discomfort 

 
 
 
 
 
 
 
2- Perineal trauma: Is any injury to the perineum during childbirth which occurs 
spontaneously (1st or second degree tear) or intentionally through a surgical incision 
(episiotomy). 
 
3- Postpartum perineal trauma outcomes: It include the following outcomes: 
a- Postpartum perineal pain: It will be assessed by Visual Analogue Scale for pain intensity 
(VAS). 
b- Postpartum perineal trauma healing: It will be assessed by standardized REEDA scale.  
c- Postpartum perineal trauma infection: It will be assessed by standardized REEDA scale. 
d- Postpartum difficulty with performing functional activities: It refers to postpartum 
difficulty with turning/ rolling in bed, getting out of bed, sitting, walking, defecation and 
urination. It will be assessed by Visual Analogue Scale (VAS) for rating functional 
activities. 
 
 
 
 Subjects and Methods 
      Research Design 
A randomized controlled trial will be used to fulfill the aim of proposed study. The 
randomized control trial (RCT) is a trial in which subjects are randomly assigned to one of 
two groups: one (the experimental group) receiving the intervention that is being tested, and 
the other (the comparison group or control) receiving an alternative treatment (Spieth et al, 
2016). 
                                             Sample 

 
 
 
 
 
 
A total of (100) postpartum women with normal spontaneous vaginal delivery and 
having postpartum perineal trauma will be recruited for this study and randomly assigned to 
either study group (50) women or control group (50) women. Inclusion criteria will be 
according to the following; primiparous or 2nd. multiparaous women with postpartum 
perineal trauma either episiotomy or perineal tear (first and second degree only), age not 
exceeding 40 years, , body mass index (BMI)within normal 18.5-24.9 kg/m2 or overweight 
25-29.9 kg/m2, free from any high risk condition affecting perineal trauma healing (e.g., 
diabetes mellitus or obesity), over 37 week gestation and  not having any complications 
during labor and delivery(e.g., abnormal presentation, obstructed labor or delivered with 
instrument), not having any immediate postnatal complications such as postpartum 
hemorrhage.  
 
The sample size was calculated using a G-power version 3.1.1 for power analysis. A 
Power of .95 (β = 1-.95 = .05) at alpha .05 (one-sided) was used as the significance level, 
and effect size= (80%). 
Setting 
The study will be conducted at postpartum ward of emergency department for labor 
and delivery in Obstetrics and Gynecology Hospital at Kasr El Aini University Hospital 
affiliated to Cairo University. Postpartum ward provides care for postpartum women with 
normal vaginal delivery and post abortion women. The capacity of the ward is 20 beds which 
provide care for approximately (3000) normal deliveries annually according to local 
statistics for the year 2020 (Kasr El Aini University Hospital Statistics, 2020). 
Tools for Data collection 

 
 
 
 
 
 
Required data will be collected by using 5 tools:  A)  Structured interview schedule;   
B) Visual Analogue Scale for pain intensity(VAS);  C) Visual Analogue Scale (VAS)  for 
rating  functional activities;  D) Standardized REEDA scale; and E) Postpartum follow up 
sheet. 
 
Tool (A) Structured Interview Schedule: This tool will be designed by the investigator and 
will include two sections: 
- The first section: Will include four items to assess participants’ demographic data such as 
(age, BMI, educational level, occupation, residence).  
- The second section: Will include four items to assess the participants current obstetric 
history (e.g., obstetric code), type of perineal trauma after delivery (episiotomy, or tears) and 
degree of perineal tear (1st or 2nd degree tear).  
 
Tool (B) Visual Analogue Scale for Pain Intensity (VAS): It is a standardized linear scale 
developed by Freyd et al., (1923). It is a self-reported 10 cm horizontal line which 
represents the subjective estimation of pain intensity. It comprises 0-10-point numerical 
scale, the two opposite ends representing no pain to severe pain as follows: no pain (0), 
mild pain (< 4), moderate pain (4  -  <   
8 ), and sever pain (8-10). This tool is valid and 
reliable, test-retest reliability coefficient of the VAS has been demonstrated in several 
studies as r =0.62 (Derya, Ergul, Senol, &Aslan, 2017). 
 
Tool (C) Visual Analogue Scale (VAS) for rating functional activities: This tool is 
adopted from Karakaya et al.,(2012), the difficulty with performing functional activities as 
(turning/ rolling in bed, getting out of bed, walking, sitting, defecation and urination) will 
be evaluated by using horizontal 10 cm visual analogue scale for each functional activity, 
the scale will be applied six times to measure the difficulty with each activity (VAS will be 

 
 
 
 
 
 
marked by the women). The scoring for each activity will be as follows: no difficulty (0), 
mild difficulty (< 4), moderate difficulty (4 - <8), and sever difficulty (8-10).  The total 
score will be recorded (0-60 point), the lowest score (0) indicate no difficulties and the 
maximum score (60) indicate maximum difficulty. The total score will be interpreted as 
the following no difficulties (0), Mild difficulties (1 - < 24), Moderate difficulties (24 - < 
48), Sever difficulties (48-60). This tool is valid and reliable, test-retest reliability 
coefficient has been demonstrated as r =0.82 (Karakaya et al., 2012). 
 
Tool (D) Standardized REEDA Scale: This tool is adopted from Davidson (1974), 
REEDA scale will be  used to assess condition of perineal trauma. REEDA scale is a 
descriptive scale having a four point categorical score (0-3) that measures five components 
associated with the healing process of perineal trauma. This includes: Redness, Edema, 
Ecchymosis, Discharge and Approximation of sutures. The total  score ranged from 0 to 15 
and categorized as the  following; 0 to 2 cm  good  wound  healing with no infection,  3  to  
5  cm  moderate  wound  healing, 6 to 8 cm mild wound healing, and 9 to 15 cm  poor 
wound healing with infection . This tool is valid and reliable, test-retest reliability 
coefficient of the REEDA scale has been demonstrated as r =0.70 (Farrag, Eswi, & 
Badran, 2016). 
 
Tool (E) Postpartum Follow up Sheet: This tool will be designed by the researcher after 
reviewing the related literature and will be revised by experts in gynecology and maternity 
nursing department and will include items to assess mother compliance with ice gel pad 
application through the first 24 hours and assess women’s need for additional analgesia.  
Also, assess the women compliance with Kegel exercise performance from six hours 
postpartum till one week and compliance with the application of warm compresses per day 
from 48 hours postpartum till one week. 

 
 
 
 
 
 
 
A designed Protocol of Care for Postpartum Perineal Trauma: It is a protocol developed 
by the investigator based on  systematic reviewed studies done by  (East; Begg; Henshall; 
Marchant; &Wallace (2009); Shahrahmani et al,(2016); East; Dorward; Whale;&Liu, 
(2020); Kridsana; Kunyanut; &Thitiporn (2020);  and several studies  as a quasi 
experimental time series study  by Farrag, Eswi, &Badran,(2016); a randomized controlled 
trial by  Derya, Ergul, Senol, &Aslan, (2017); and a quasi experimental study by  Khosla 
&Pratibha, (2017); a quasi experimental  study by Yuliani, Rizka,(2019). 
 
The protocol entails a combination of evidence-based therapies for postpartum perineal 
trauma that is applied in steps starting from immediate postpartum and continues throughout 
the first week in order to relieve immediate and sustained perineal trauma. 
 
 
Description of the protocol: 
1. Application of perineal ice gel pad: Immediately postpartum (within 30 minutes to one 
hour) and through the first 24 hours postpartum to help reduce perineal pain, edema and 
stimulate repair process.  
2. Postpartum performance of pelvic floor exercises (Kegel exercises): After six hours till 
one week postpartum to accelerate healing of perineal trauma and for further reduction of 
sustained perineal pain. 
3. Postpartum perineal warm compresses: After 48 hours till one week postpartum to 
promote better healing of perineal trauma, prevent complications, prevent infection and 
further reduction of sustained perineal pain. 
 
Ethical consideration 

 
 
 
 
 
 
The primary official permission will be obtained from the research ethics committee 
of faculty of nursing, Cairo University to approve the tools and the study. Also, the 
investigator will explain to the women the purpose and nature of the study and its 
importance. In addition, informed written consents will be obtained from women who were 
willing to participate in the study after ensuring that their participation is voluntary and the 
trial posed no risk or hazards on them. As well, each woman will be assured that she has the 
right to withdraw of the trial at any time without any effect on her care.  Then, 
confidentiality will be assured through coding of data by the investigator and keeping the 
data in a secret place. 
Validity and reliability 
 
 
 Un standardized tools were submitted to 3 experts in the field of maternity nursing 
to test content validity, clarity of sentences and an appropriateness of content. Modifications 
were carried out according to the expert judgment. 
Procedure 
First, the primary official permission will be obtained from the research ethics 
committee of faculty of nursing, Cairo University to approve the tools and the study. An 
official permission will be granted from the hospital administrative personnel in the 
recommended setting to collect the data. Then, data collection will be carried out through 
five steps in each group: Recruitment & randomization; interviewing; initial assessment; 
intervention; follow up and monitoring.  
 
Recruitment and Randomization of sample: Women who will meet the eligibility criteria 
will be recruited from a written list done by the investigator every day. Those plotted in the 
odd number will be selected until completion of the sample. Random assignment of the 
subjects into two groups will be done through an opaque sealed envelope reflecting the type 
of each group, and then the eligible women will be asked to choose an envelope to 

 
 
 
 
 
 
determine their groups. 
 
Interviewing:  During interview the aim of study will be explained to the women in both 
groups (study & control group) to gain their acceptance to participate in the study then data 
related to socio-demographic status and obstetric history will be collected from both groups  
 
Initial Assessment:   Initial assessment for women in both groups (study & control group) 
will be carried out in relation to  body mass index (BMI), type of perineal trauma after 
delivery (episiotomy, or tears), degree of perineal tear (1st or 2nd degree tear), and 
assessment of perineal trauma condition will be done using standardized REEDA scale . 
Also, women will be asked to indicate the degree of perineal pain using Visual Analogue 
Scale for pain intensity (VAS).This assessment will take 15 minutes for each woman. 
 Intervention:  
Intervention for the study group:  For the study group the intervention will be according to a 
designed protocol of care that entails; 1) Application of ice gel pad on perineal trauma for 
the first 24 hours post partum; 2) Performance of pelvic floor exercises (Kegel exercises) 
from six hours till one week postpartum; 3) Application of warm compresses after 48 hours 
and through the first week postpartum. The investigator will perform demonstration and then 
redemonstration by the women on each intervention will be done. A designed booklet 
(developed previously) that explains each intervention will be given to each woman. 
 
Immediately after delivery (within 30 minutes to one hour after delivery), an ice gel 
pad will be applied to perineal trauma.  It  will be available  in  an  individual  package(every 
woman will alternate between two ice gel pads);  each  gel  pad  will have fixed standardized 
diameter  (an  approximately  5  cm  width,  23  cm  length,  and  1.5  cm  thickness) and 
approved by Egyptian ministry of health.  It will be kept in the freezer for 45–60 minutes and 

 
 
 
 
 
 
will be removed when frozen. Then, it will be wrapped in a sterile pad and applied to cover 
the perineum and anal region. The pad will be compatible with the anatomical structure of 
the perineum. 
 
The investigator will provide a clear and concise information through oral and 
written instructions about the following; 1) The ice gel pad`s purpose, benefits, anticipated 
effects and how to apply it, 2) Apply the ice gel pad on perineum after birth within 30 
minutes to an hour, 3) Instruct the women to apply the ice gel pad for about 20 minutes 
every two hours during the first 24 hours postpartum only, 4) The perineal pad should be 
changed regularly every two hours to prevent infection. This session will take 30-40 minutes 
for each woman. Then, six hours after the ice gel pad application, assessment of experienced 
perineal pain will be done using Visual Analogue Scale for pain intensity (VAS) and 
assessment of perineal trauma condition will be done using standardized REEDA scale. 
 
  
Also, six hours after birth women will receive instructions to practice pelvic floor 
exercises (Kegel exercises) and will be asked to perform these exercises from 6 hours 
postpartum and continue at home till one week. Before applying the technique, the 
investigator will teach the women how to recognize the accurate muscle, whereby she 
imagines holding passing gases or trying to stop the flow of urine midstream at the same 
time.  The women will be taught to insert a clean finger into the vagina before practicing the 
exercises and if the women feeling pressure around her finger, she is on the right track, the 
mother also will be instructed to place a hand on her belly during the exercises to make sure 
that it is kept relaxed. 
 
The investigator will perform vaginal examination while the woman is doing the 
pelvic floor exercises (Kegel exercises) to ensure correct use of muscles. The investigator 

 
 
 
 
 
 
will instruct the women to continue contracting the muscles for about 5 seconds and then to 
loosen them for 5 seconds and repeat it for five times each set, perform at  least five sets per 
day ( total 25 contractions each day will be performed). The mother will be instructed to 
perform these five sets of exercises at the rest period between other intervention (application 
of cold compresses for the first 24 hours and application of warm compresses after 48 hours) 
with at least two hours rest between each set. 
 
 
In addition, women will be instructed to apply warm compresses on perineal trauma 
48 hours postpartum +at home. This will be done by using a clean pad soaked in warm water 
and squeezed to remove excess water then placed gently on the perineum, the warm 
compresses will be applied for 15 minutes three times per day (every 8 hours), and water in 
the bowl will be replaced with every application. Women will be asked to apply warm 
compresses on perineal trauma from 48 hours postpartum till one week. Also, before 
discharge each woman will have an explanation of Visual Analogue Scale for pain intensity 
(VAS) and they will be trained to indicate level of perineal pain using it. This session will 
take 30-40 minutes for each woman. 
 
Intervention for the control group:  The control group will receive the routine 
hospital care only. Then, six hours after delivery, assessment of experienced perineal pain 
will be done using Visual Analogue Scale for pain intensity (VAS) and assessment of 
perineal trauma condition will be done using standardized REEDA scale. 
 
Follow up and monitoring: Follow up will be done by telephone calls and by postpartum 
visit at the seventh day: 
For intervention group follow up by telephone call will be done at 24 hours to assess 
the following; degree of perineal pain using Visual Analogue Scale for pain intensity (VAS), 

 
 
 
 
 
 
the women compliance with ice gel pad application for the first 24 hours, the women’s need 
for additional analgesia and assess women’s postpartum difficulty with performing 
functional activities as turning/ rolling in bed, getting out of bed, sitting, walking, defecation 
and urination using Visual Analogue Scale(VAS) for rating functional activities.  
 
Also, telephone follow up will done at third and fifth day postpartum to assess degree 
of perineal pain using Visual Analogue Scale for pain intensity (VAS) and assess women’s 
postpartum difficulty with performing functional activities as turning/ rolling in bed, getting 
out of bed, sitting, walking, defecation and urination using Visual Analogue Scale(VAS) for 
rating functional activities. The investigator will also assess mother compliance with the 
performance of pelvic floor exercises (Kegel exercises) and application of perineal warm 
compresses using postpartum follow up sheet. 
 
For control group follow up by telephone call will be done at 24 hours to assess 
degree of perineal pain using Visual Analogue Scale for pain intensity (VAS), the women’s 
need for additional analgesia and assess women’s postpartum difficulty with functional 
activities as turning/ rolling in bed, getting out of bed, sitting, walking, defecation and 
urination using Visual Analogue Scale (VAS) for rating functional activities. Also, telephone 
follow up will be done at third and fifth day postpartum to assess degree of perineal pain 
using Visual Analogue Scale for pain intensity (VAS) and assess women’s postpartum 
difficulty with performing functional activities as turning/ rolling in bed, getting out of bed, 
sitting, walking, defecation and urination using Visual Analogue Scale (VAS) for rating 
functional activities. 
 Then, a final postpartum follow up visit for both groups at the seventh day will be 
conducted for assessment of perineal trauma condition and healing process using 

 
 
 
 
 
 
standardized REEDA scale and assess the degree of perineal pain using Visual Analogue 
Scale for pain intensity (VAS). 
 
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27 
 
Statistical plan 
Data were statistically described in terms of mean ± standard deviation (± SD), or 
frequencies (number of cases) and percentages when appropriate. Because the groups are 
large enough, comparison of numerical variables between the study groups was done 
using a student t test for independent samples (including  statistical analysis of  the 
primary outcomes as perineal pan scores and perineal trauma healing scores among the 
study and control groups). For comparing categorical data , the chi-square test was 
performed(including  statistical analysis of  the difficulties with functional activities; 
secondary outcome). An exact test was used when the expected frequency was less than 5. 
Two sided p values less than 0.05 were considered statistically significant. All statistical 
calculations were done using the computer programme IBM SPSS (Statistical Package for 
the Social Sciences; IBM Corp., Armonk, NY, USA), release 22 for Microsoft Windows.