Objective: to evaluate the effectiveness of Gel pads, as a method of Cold Therapy, and the Essential Lavender Oil in healing and pain intensity of episiotomy. The study population included 90 primiparous mothers who had the inclusion criteria of this study. These mothers allocated into either a control or experimental groups randomly. The experimental groups received either Gel pads or six drops of pure Lavender oil into the bath water for 5 days following child birth, while the control group received routine cares. Perineal pain intensity was evaluated using Visual Analogue Scale within 4 hours, 12 hours and 5 days after episiotomy. Perineal healing was evaluated using REEDA scale in 5 days after episiotomy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807192248N3
Registration date:2010-04-26, 1389/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-26, 1389/02/06
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2009-07-29, 1388/05/07
Expected recruitment end date
2009-11-06, 1388/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cold Therapy and the Essential Lavender Oil on pain intensity and healing of episiotomy among primiparous women
Public title
Influence of Cold Therapy and Essential Lavender Oil on episiotomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being primiparous
Exclusion criteria: heart, respiratory or renal disease, eclampsia and preeclampsia, history of allergies to special medicine, laceration, pregnancy membrane prolonged more than 24 hours, fast labor, drug addiction, vulva and vaginal symptomatic inflammation, creation of heamatoma in episiotomy during the first 24 hours, taking medication more than routine when admitted in hospital
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery, Iran University of Medical Sciences
Street address
Next to the Mottahari hospital, Rashid-Yasmi street, Valiasr avenue
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
1323572
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O75.9
ICD-10 code description
Complication of labour and delivery, unspecified
Primary outcomes
1
Description
Pain intensity of episiotomy
Timepoint
4 hours, 12 hours and 5 days after episiotomy
Method of measurement
Visual Analouge Scale
Secondary outcomes
1
Description
Healing of episiotomy
Timepoint
5 days after episiotomy
Method of measurement
REEDA Scale
Intervention groups
1
Description
Cold Therapy during pain
Category
Other
2
Description
Essential Lavender oil, six dropes into the bath water twice a day for 5 dayes
Category
Other
3
Description
Routine care in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. A. Motevalian, Vice Chancellor for research of Iran University of Medical Sciences
Street address
Shahid hemat highway, south side, between shahid Sheikh Fazlollah noori and Shahid Chamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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, Iran University of Medical Sciences
Full name of responsible person
Fatemah Sheikhan
Position
master sciences of midwifery
Other areas of specialty/work
Street address
Next to the Mottahari hospita, Rashid yasmi street, Valiasr avenue
City
Tehran
Postal code
19395/4798
Phone
+98 21 4408 8667
Fax
Email
f.sheikhan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Fereshteh Jahdi
Position
Master of Science,faculty of nursing and midwifery
Other areas of specialty/work
Street address
Next to the Mottahari hospital, Rashid yasmi street, Valiasr avenue
City
Tehran
Postal code
Phone
+98 21 8247 1404
Fax
Email
jahdi_fr@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)