Objective: This research was done to evaluate the effectiveness of two cooling devices (gel pad with ice pack )and compare these with no localised treatment (control) on intensity perineal pain after episiotomy in primiparous women
inclusion criteria: Iranian (Dewill Mashhad) nationality; primparous; age 16-35 years; Occiput anterior presentation; Singleton birth; Birth weight (2500-4000 g); Have addresses and telephone number.
exclusion criteria:women with any medical disorders or obstetric complications; Fetal anomally; Stillbirth; Needing neonatal intensive care unit; Retained placenta; Smoking; Consumption of alcohol or continouse drugs; Rupture membrane> 12 hours; Stretch or massage of perineum in pregnancy or during delivery stages; use of lubricant during delivery; second stage of delivery >120 minutes; postpartum haemorrhage; haematoma
Population: primiparous women
Sample size:121
Intervention : this randomized controlled trial done on 121 primiparouse women who were at term and had an episiotomy were randomly recruited to one of three treatment groups( Group 1: no localized cooling; Group2: Ice pack; Group3: Cooling gel pad), .participants used of the treatment in early 4 hr and during 10 days According to their requests.
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Time intervention: october 2005 to february 2006
Primary outcome measure:The intensity of episiotomy pain 4hr;1;2;5;10th days
Secondary outcome:The wound healing:4hr;1;2;5;10th days and women's satisfaction levels
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107167038N1
Registration date:2011-08-11, 1390/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-11, 1390/05/20
Registrant information
Name
Shahin Dokht Navvabi-Rigi
Name of organization / entity
Zahedan University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 1242 1259
Email address
navabi_rigi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University Of Medical Science
Expected recruitment start date
2005-09-23, 1384/07/01
Expected recruitment end date
2006-01-21, 1384/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectivness of cooling gel pads and ice packs on perineal pain and wound healing after episiotomy
Public title
Effect cold on episiotomy pain and wound healing
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Iranian (Dewill Mashhad) nationality; primparous; age 16-35 years; Occiput anterior presentation; Singleton birth; Birth weight (2500-4000 g); Have addresses and telephone number.
exclusion criteria:women with any medical disorders or obstetric complications; Fetal anomally; Stillbirth; Needing neonatal intensive care unit; Retained placenta; Smoking; Consumption of alcohol or continouse drugs; Rupture membrane> 12 hours; Stretch or massage of perineum in pregnancy or during delivery stages; use of lubricant during delivery; second stage of delivery >120 minutes; postpartum haemorrhage; haematoma
Age
From 16 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
121
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University Of Medical Science
Street address
Mashhad University Of Medical Science; faculaty research & IT; Mashhad; Khorasan Razavi
City
Mashhad
Postal code
Approval date
2005-11-30, 1384/09/09
Ethics committee reference number
84225
Health conditions studied
1
Description of health condition studied
Episiotomy Pain
ICD-10 code
070
ICD-10 code description
070
Primary outcomes
1
Description
intensity perineal pain
Timepoint
4 hr; 1,2,5 and 10th days
Method of measurement
NRS(Numeric Rating Scale)
Secondary outcomes
1
Description
wound healing episiotomy
Timepoint
4 hr; 1,2,5 and 10th days
Method of measurement
REEDA scale
2
Description
use of analgesia
Timepoint
during 10 days
Method of measurement
registration number og analgesia in checklist
3
Description
women's satisfation level
Timepoint
10th day
Method of measurement
numering rating scale
Intervention groups
1
Description
group1: no localized treatment
Category
Treatment - Drugs
2
Description
group2:Ice Pack
Category
Treatment - Devices
3
Description
group3: cooling gel pad
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-E-Omolbanin Women Hospital;
Full name of responsible person
Dr Monireh Poorjavad
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University Of Medical Science
Full name of responsible person
Zahra Abedian
Street address
midwifery group ; Nursing and Midwifery School; Avecina Street; Mashhad University Of Medical Science; Khorasan Razavi
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?