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| Name | Class |
|---|---|
| Cairo University | OTHER |
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the study is intended to test the effect of designed protocol of care that include perineal ice-gel pad application, performance of pelvic floor exercises (Kegel exercises) and perineal warm compresses application on the outcomes of postpartum perineal trauma among women with vaginal delivery at postpartum ward.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.
This randomized controlled trial will be conducted to test the effect of designed protocol of care that include; perineal ice-gel pad application for the first 24 hours after delivery, performance of pelvic floor exercises (Kegel exercises) for six hours till one week postpartum and perineal warm compresses application from 48 hours till one week postpartum on the outcomes of postpartum perineal trauma .The study will be conducted on (100) postpartum women with normal spontaneous vaginal delivery and having postpartum perineal trauma that randomly assigned to either study group (50) women or control group (50) women.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.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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | the study group will recelve adesigned protocol of care that entails three interventions as the following1) 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. |
|
| control group | No Intervention | The control group will receive the routine hospital care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-perineal ice-gel pad application | Other | For the study group Immediately after delivery (within 30 minutes to one hour after delivery), an ice gel pad will be applied to perineal trauma. 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Postpartum Perineal Pain | Postpartum severity of perineal pain will be assessed by Visual Analogue Scale for pain intensity (VAS).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). | one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, day 7 after delivery |
| Postpartum Perineal Trauma Healing | Postpartum perineal trauma healing will be assessed by standardized Redness,Edema,Echymosis,Discharge,Approximation of sutures( REEDA) scale.The total score ranged from 0 to 15 and categorized as the following; 0 to 2 good wound healing , 3 to 5 moderate wound healing, 6 to 8 mild wound healing, and 9 to 15 poor wound healing . the lower score 0 and the maximum score 15 , as the score decreases it indicate better wound healing | one hour after delivery, six hours after delivery, day 7after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Postpartum Perineal Trauma Infection | Postpartum perineal trauma infection will be assessed by standardized REEDA scale. the score ranged from 0-15 , score from 0 to 2 indicates no wound infection,while from 3-15 indicates wound infection | day 7 after delivery |
| Postpartum Difficulty With Performing Functional Activity |
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Inclusion Criteria:
Inclusion criteria will be according to the following
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asmaa Abdallah | Cairo University | Principal Investigator |
| Yousria Ahmed | Cairo University | Study Director |
| Shadia Abdel Kader | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of nursing/Cairo university& Kasr El Aini University Hospital | Cairo | El-manial | 11553 | Egypt |
no participants were excluded for the study after enrollment and before assignment to study or control group
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Intervention for the study group was carried out according to a designed protocol of care that entails: 1) application of an ice gel pad on perineal trauma for 20 minutes every two hours during the first 24 hours postpartum; 2) performance of pelvic floor exercises (Kegel exercises) five times daily starting from six hours till one week postpartum; and 3) application of warm compresses for 15 minutes three times daily starting after 48 hours and through the first week postpartum. On each intervention, the investigator demonstrated and then redemonstrated with the women. A specially designed booklet (developed previously) that explains each intervention was given to each woman. |
| FG001 | Control Group | the control group received the routine hospital care (antibiotic every 12 hours and analgesic as needed ) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Intervention for the study group was carried out according to a designed protocol of care that entails: 1) application of an ice gel pad on perineal trauma for 20 minutes every two hours during the first 24 hours postpartum; 2) performance of pelvic floor exercises (Kegel exercises) five times daily starting from six hours till one week postpartum; and 3) application of warm compresses for 15 minutes three times daily starting after 48 hours and through the first week postpartum. On each intervention, the investigator demonstrated and then redemonstrated with the women. A specially designed booklet (developed previously) that explains each intervention was given to each woman. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | the age of participants included at the study was from 18-40 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Severity of Postpartum Perineal Pain | Postpartum severity of perineal pain will be assessed by Visual Analogue Scale for pain intensity (VAS).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). | severity of postpartum perineal pain | Posted | Mean | Standard Deviation | score on a scale | one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, day 7 after delivery |
|
over one week pospartum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | Intervention for the study group was carried out according to a designed protocol of care that entails: 1) application of an ice gel pad on perineal trauma for 20 minutes every two hours during the first 24 hours postpartum; 2) performance of pelvic floor exercises (Kegel exercises) five times daily starting from six hours till one week postpartum; and 3) application of warm compresses for 15 minutes three times daily starting after 48 hours and through the first week postpartum. On each intervention, the investigator demonstrated and then redemonstrated with the women. A specially designed booklet (developed previously) that explains each intervention was given to each woman. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asmaa Abdallah Ahmed Hussein | Faculty of nursing /cairo university | 01006961502 | asmaaabdallah.cu@cu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2023 | Apr 20, 2024 | Prot_SAP_000.pdf |
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after obtaining the primary and official permission data collection will be carried out through five steps in each group: Recruitment & randomization; interviewing; initial assessment; intervention; follow up and monitoring. : 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.The control group will receive the routine hospital care only
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| 2-performance of pelvic floor exercises (Kegel exercises) | Other | 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 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 |
|
| 3- perineal warm compresses application | Other | 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. |
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postpartum difficulty with performing functional activity as (turning/rolling in bed, getting out of bed, sitting, walking, defecation and urination) will be assessed using Visual Analogue Scale for rating functional activity.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). |
| 24 hours after delivery, day 3 after delivery, day 5 after delivery |
| BG001 | Control Group | The control group received the routine hospital care only |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| level of education | Count of Participants | Participants |
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| occupation | Count of Participants | Participants |
|
| residence | Count of Participants | Participants |
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| gravidity | primigravida : women who is pregnant on time gravida 2: women who is pregnant 2 times gravida 3: women who is pregnant 3 times gravida 4: women who is pregnant 4 times | Count of Participants | Participants |
|
| Body Mass Index(BMI) | normal weight: when BMI between (18.5- 24.9 kg/m2 ), overweight : when BMI between (25- 29.9 kg/m2) | Count of Participants | Participants |
|
| type of perineal trauma | Count of Participants | Participants |
|
| OG001 | Control Group | The control group received the routine hospital care |
|
|
| Primary | Postpartum Perineal Trauma Healing | Postpartum perineal trauma healing will be assessed by standardized Redness,Edema,Echymosis,Discharge,Approximation of sutures( REEDA) scale.The total score ranged from 0 to 15 and categorized as the following; 0 to 2 good wound healing , 3 to 5 moderate wound healing, 6 to 8 mild wound healing, and 9 to 15 poor wound healing . the lower score 0 and the maximum score 15 , as the score decreases it indicate better wound healing | severity of postpartum perineal pain | Posted | Mean | Standard Deviation | score on a scale | one hour after delivery, six hours after delivery, day 7after delivery |
|
|
|
| Secondary | Occurrence of Postpartum Perineal Trauma Infection | Postpartum perineal trauma infection will be assessed by standardized REEDA scale. the score ranged from 0-15 , score from 0 to 2 indicates no wound infection,while from 3-15 indicates wound infection | postpartum perineal wound infection | Posted | Count of Participants | Participants | day 7 after delivery |
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|
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| Secondary | Postpartum Difficulty With Performing Functional Activity | postpartum difficulty with performing functional activity as (turning/rolling in bed, getting out of bed, sitting, walking, defecation and urination) will be assessed using Visual Analogue Scale for rating functional activity.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). | postpartum difficulties with daily infection | Posted | Count of Participants | Participants | 24 hours after delivery, day 3 after delivery, day 5 after delivery |
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|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Control Group | The control group received the routine hospital care | 0 | 50 | 0 | 50 | 0 | 50 |
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| Preparatory School |
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| Secondary School |
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| University School |
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| Gravida 3 |
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| Gravida 4 |
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| both episiotomy and perineal tear |
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| day 7 after delivery |
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| moderate difficulty |
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| sever difficulty |
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| day 3 after delivery |
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| day 5 after delivery |
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