Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04360382 |
| Other study ID # |
IRB approval number.258691 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2020 |
| Est. completion date |
June 1, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Woman's Health University Hospital, Egypt |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A protocol of ERACS is introduced to our hospital aiming at saving a lot of time and money
for the patients and the population at large .By this way ,free beds for more cases can be
available for others patients, so the researcher is welling to study this research on women
undergoing CS at Woman's Health University Hospital.
Description:
This study aims to assess the level of satisfaction of the women undergoing Enhanced Recovery
Program (ERP) versus conventional care after cesarean section..
The study will be conducted at the woman's Health University Hospital at obstetrics ward and
postpartum ward of that hospital,at the Assuit
The sample size for this study will be 300 randomized -controlled trails women and divided
into two groups :
The first 150 of women will be enrolled to the control group, receiving conventional care and
the second 150 of women will be recruited to the study group , receiving enhanced recovery
program based care .
- Randomization will done by using computer -generated random table.
- After acceptance of eligible women to participate in the study ,they will assigned
randomly to either one of the above groups.
Two tools will be used to collect data of this study:
Tool I: perioperative cesarean Section assessment tool:
This tool will be developed by the researcher based on reviewing available related literature
and will be used to collect data regarding outcomes .
This tool will include the following parts:
Part 1:women's personal data: Consisted of 6 questions such as age, level of education ,
occupation, weight, height, indication for CS ,date ,time of admission and discharge .
Part 2: preoperative Data: Consisted of 13 questions such as present medical ,past and
surgical histories, obstetric history ,smoking history , vital signs, investigations, patient
advice and information ,breast feeding education ,discuss NPO status (reduced fasting times
),hemoglobin optimization ,contact women the day before delivery to review ERAS goals , bowel
preparation, ,medications, time of transfer to theatre.
Part 3:Intraopreative Data: Consisted of 10 questions such as duration of operation , total
fluid replacement ( including blood transfusion), vital signs ,urine output ,active warming,
delayed cord clamping , skin to skin contact on operation table , minimally invasive surgical
technique, anesthetic and analgesia medication .
Part 4:Post-operative Data: Consisted of 16 questions such as time of admission to ward, time
of starting oral fluid, time of mobilization , time of remove urinary catheter ,duration of
IV fluid ,use of chewing gum in early postoperative period ,pain intensity , use of analgesia
drug and anibiotics,postoperative complication, pain intensity on discharge ,postoperative
length of stay and reason of delayed postoperative length of stay.
Tool II: Patient's satisfaction tool:
This tool will be developed by researcher based on reviewing related literature including
existing satisfaction tools, tested of validity ,piloted for internal consistency reliability
,scored and will utilize to assess patient's satisfaction about quality of perioperative care
services. It is six domains and 40 items. Hospital admission procedure domain ( has 4
domains) such as women satisfied about ease of overall ,health care domain (has 10 domains)
such as women satisfied about number of around made of doctor, physician services
,information provision domain (has 13 domains) such as women satisfied about information of
breast feeding and pain management , ,the personal treatment domain (has 5 domains) such as
women satisfied about kindness of staff , food domain (has 3 domains) such as women satisfied
about served food quality (has 5 domains) such as women satisfied about cleanliness in the
room and hospital facilities .
- Patient's satisfaction will measures by using four points Likert's scale ; Four point
Likert's format that goes from strongly satisfied (4) to strongly dissatisfied (1), which
helps in obtaining an ordinal measure of the strength of the satisfaction with each item. The
tool score range from 40 to 160 .The score of ≤ 80 = dissatisfied, the range score > 80- 120
= satisfied , and the range score of > 120 - 160 = very satisfied (Ahmed et.al,2017).
Validity of data collection tools Content validity of the data collection tools will be
established by 5 experts in the field of the study .The necessary modifications will be done
accordingly.
Pilot study:
A pilot study will be carried out on the first 10 % of the total sample to test the content
validity, feasibility, clarity and objectively of the tool as well as estimate the time
needed for data collection. Data will analyzed manually following pilot study. According to
the result of pilot study the necessary modifications will be done accordingly.
procedure: An written official approval letter from Faculty of Nursing at the University of
Assuit to the director of Women Health Hospital; this letter will include a brief explanation
of the objective and permission to carry out the study .
Data will be collected from control group first and then from study group to prevent sample
contamination. The control group will receive the conventional care while study group will
receive developed enhanced recovery program care .
Phase 1: Conventional Care Assessment Perioperative data will be collected from this group by
tool I .Every patient will be assessed at a day before operation to gather all preoperative
data .the women's operative report is reviewed by researcher and required information will be
recorded on data collection tool .After that women will be followed up till she is
transferred to postpartum ward where patient will daily be reassessed during morning shift
till patient discharge. The patient's satisfaction will be assessed at discharge using tool
II .
Phase 2: Designing enhanced recovery program:
Based on reviewing related to literature; enhanced recovery program after cesarean section
will be formulated by a designer team, which will consist of a supervisor and head nurse of
ward, and researcher.
The established enhanced recovery pogram will consist of four parts:
Part I: Preoperative evaluation and preparation:
This part will include health history, physical examination, and diagnostic investigation, as
well as pre-operative patient preparation.
Part II: Postoperative daily intervention:
This part will include the daily nursing and collaborative interventions such as assessment,
nutrition, activities, medications, patient and family education, and discharge planning and
instructions.
Part III: Expected daily outcome :
This part will include the patient's daily outcomes such as vital signs stability , pain
control ,activities of daily living and mobility improvement; return bowel function, and
meeting discharge criteria .
Phase three: Implementing enhanced recovery program:
The established pathway will implement on the study group by researcher from admission till
discharge as conventional care group assessment in phase one.
Phase four: Evaluating enhanced recovery program outcomes:
The efficacy of enhanced recovery program will be determined by comparing outcomes for
patients of both control and study groups
