1. Home
  2. Approved trials
  3. » فارسی

Comparison the effect of cooling gel pads and topical olive oil on the intensity of episiotomy pain and wound healing in primiparous women referring to hospitals affiliated with the Gilan university of Medical Sciences in 2014

Protocol summary

Summary
The present study has been conducted to evaluate and compare the effect of cooling gel pads and topical olive oil on the intensity of episiotomy pain and wound healing in primiparous women referring to hospitals affiliated with the Gilan University of Medical Sciences in 2014. This study was randomized clinical trial, without blindness, without placebo. In this study the sample consisted of primiparous women with vaginal delivery and episiotomy referring to hospitals affiliated with the Gilan University of Medical Sciences who have characteristics participants. Inclusion criteria: gestational ages between 37 and 42 weeks; the lack of diseases such as chronic systemic disorders, cardiovascular, respiratory, coagulation disorders and connective tissue, diabetes, anemia, immunosuppressant, hemophilia, malnutrition and psychological disorders; no allergies to topical drugs; no rupture of membranes more than 24 hours; no manual removal of placenta; not taking the first stage of labor (more than 14 hours) and the second stage of labor (more than 2 hours) and the third stage of labor (more than 30 minutes); no problems with cold therapy such as poor circulation and lower pain sensitivity to cold. Exclusion criteria: do not use the cooling gel pads and olive oil properly and as directed; allergic to use olive oil; have a sex in the first 5 days after birth; episiotomy hematoma in the first 24 hours after delivery. In this study, 90 women participated in research project into two groups of cooling gel pads (n =45) and topical olive oil (n =45). After completing the questionnaire (demographic and obstetric and midwifery questionnaire), informed consent and was selected as sample. Then samples were randomly allocated to two groups: cooling gel pad and olive oil. Mothers who use the cooling pad was asked after washing and drying the perineum, covered pads with gauze and mothers used it for 20 minutes whenever they needed. Mothers who use the olive oil was asked after washing and drying the perineum, olive oil gently placed on the wound 2 times a day for 10 days and then were used the pad after 1-2 minutes. Perineal pain intensity was evaluated using Visual Analogue Scale (VAS) and the wound healing was assessed by the REEDA scoring scale. Then episiotomy healing assessed on 12 hours after delivery, 5 and 10 days postpartum.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409164529N12
Registration date: 2014-10-30, 1393/08/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-30, 1393/08/08
Registrant information
Name
Nourossadat Kariman
Name of organization / entity
Shaheed Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 3133
Email address
n_kariman@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-07-03, 1393/04/12
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of cooling gel pads and topical olive oil on the intensity of episiotomy pain and wound healing in primiparous women referring to hospitals affiliated with the Gilan university of Medical Sciences in 2014
Public title
The effect of cooling gel pads and topical olive oil on the intensity of episiotomy pain and wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primiparous woman; aged 18 to 35 years; have a vaginal delivery with mediolateral episiotomy without instrumental delivery and without tears; singleton birth with cephalic presentation; was educated; resident in Gilan; gestational ages between 37 to 42 weeks; child weigh between 2500 to 4000 grams; the lack of diseases such as chronic systemic disorders, cardiovascular, respiratory, coagulation disorders and connective tissue, diabetes, anemia, immunosuppressant, hemophilia, malnutrition and psychological disorders; no allergies to topical drugs; not eclampsia and pre-eclampsia; no rupture of membranes more than 24 hours; no addiction; BMI between 19.8-30 kg/m2; no manual removal of placenta; no fetal anomaly or bedfast to the neonatal unit; not taking the first stage of labor (more than 14 hours) and the second stage of labor (more than 2 hours) and the third stage of labor (more than 30 minutes); not problems with cold therapy such as poor circulation and lower pain sensitivity to cold. Exclusion criteria: do not visit for care; do not use the cooling gel pads and olive oil properly and as directed; not interested to continue to participate in the study; allergic to use olive oil; have a sex in the first 5 days after birth; manipulation of the perineum after episiotomy repair; use drugs on wound healing (anticoagulant, antidepressants, antiepileptic, alcohol, immunosuppressant drugs, antibiotics, chemotherapy) during the study; have a episiotomy hematoma in the first 24 hours after delivery.
Age
From 18 years old to 35 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study the randomization was based on the consultation with professor of statistics and determine the number of samples, Excel file was available to the researcher that groups code (1= cooling gel pad group, 2= olive oil group) had put it randomly. Consecutive samples were assigned to each group based on their order in the Excel file.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2014-08-07, 1393/05/16
Ethics committee reference number
154

Health conditions studied

1

Description of health condition studied
episiotomy
ICD-10 code
O70.1
ICD-10 code description
Second degree perineal laceration during delivery Perineal laceration, rupture or tear as in O70.0, also involving: pelvic floor, perineal muscles, vaginal muscles during delivery

Primary outcomes

1

Description
Intensity of episiotomy pain
Timepoint
before intervention, 12 hours, 5 and 10 days postpartum.
Method of measurement
Visual Analogue Scale (VAS)

2

Description
wound healing of episiotomy
Timepoint
before intervention, 12 hours, 5 and 10 days postpartum.
Method of measurement
REEDA scale

Secondary outcomes

empty

Intervention groups

1

Description
Olive oil group: Mothers who use the olive oil was asked after washing and drying the perineum, olive oil gently placed on the wound 2 times a day for 10 days and then were used the pad after 1-2 minutes.
Category
Treatment - Drugs

2

Description
Cooling gel pad group: Mothers who use the cooling pad was asked after washing and drying the perineum, covered pads with gauze and mothers used it for 20 minutes whenever they needed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amini Hospital Langerood
Full name of responsible person
Raheleh Amani
Street address
City
Langerood

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Rezghi
Street address
Velenjak Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Noralsadat Kariman
Position
PHD of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing And Midwifery, Valiasr St, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
Email
sbnmf@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rahele Amani
Position
Master student of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Valiasr St, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
Email
sbnmf@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rahele Amani
Position
Master Student of Midwifery
Other areas of specialty/work
Street address
City
Tehran
Postal code
4475157871
Phone
+98 218865536671
Fax
Email
rahilamani94@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...