The aim of study: Comparison effect of Aromatherapy oil Rose and warm water Footbath in active phase of labor, on Anxiety and Pain severity in primiparous women. A Randomized, not blinded, controlled, single-center, phase two trial. Inclusion criteria: the prediction of vaginal delivery with a normal history and physical examination by a medical team. No known history of allergy and asthma and anxiety and depression. Exclusion criteria: Any reasons during the Labour, Start out of the labor and requiring special care or having an emergency cesarean section, Sensitivity to oil, Unwillingness to continue participation in the study. Sample size: 120. Type of Intervention: inhalation, foot bath and foot bath with essential oil of Damask rose and hot water. Time involved: the active phase of labor and transitional. outcomes: reducing anxiety and labor pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112192751N4
Registration date:2012-03-19, 1390/12/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-19, 1390/12/29
Registrant information
Name
Masoomeh Kheirkhah
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8247 1000
Email address
kheirkhah@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of aromatherapy Rose oil and warm water in footbath in active phase of labor, on anxiety and pain severity in primiparous women
Public title
The effect of aromatherapy on pain and anxiety of labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- primiparous women with physical and mental health patients in the active phase; 2- the prediction of vaginal delivery with a normal history and physical examination by a medical team. 3- The Midwifery no problems in accepting the views of abnormal embryos, multiple pregnancies, fetal macrosomia, and pelvic disproportion, polyhydramnios, olygohydramnios, preeclampsia, premature placental separation, placenta previa, fast delivery and uterine infections; 4- with a singleton pregnancy, cephalic view; 5- no risk of hypertension, diabetes and other medical disorders in pregnancy; 6- no history of asthma, allergies; 7- No known disease, anxiety and depression; 8- Failure to take anti-anxiety and depression as a routine; 9- No risk of skin diseases like eczema, and any wound in the foot bath; 10- Having spontaneous contractions; 11- Technology and the use of painkillers such as pethidine and anxiety during labor, entonox, acupressure, acupuncture, etc. Exclusion criteria: 1- All mothers of the natural course of maternal or fetal Labor Start due to factors such as detachment, cord prolapse, fetal distress out or for any reason during the Labor Start out of the labor and require special care or have an emergency cesarean section; 2- Sensitivity and allergy to the use of essential oils; 3- Lack of desire to continue participating in the study; 4- Use of drugs such as oxytocin labor catalyst; 5- Use of an analgesic such as pethidine.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Tehran University of Medical Sciences
Street address
Central apartment of Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Postal code
Approval date
2012-02-18, 1390/11/29
Ethics committee reference number
90/د/130/2260
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
O94-O99
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
Anxiety
Timepoint
Anxiety during pregnancy: before and immediately after intervention and anxiety before and 24 hours after the active phase of labor
Method of measurement
anxiety visual analog scale anAnxiety Inventory Spielberger
2
Description
Pain
Timepoint
Every 30 minutes
Method of measurement
Visual analogue of pain
Secondary outcomes
empty
Intervention groups
1
Description
Group 2: bathing the feet with warm water for 10 minutes.
Category
Other
2
Description
Control group: routine delivery room care.
Category
N/A
3
Description
Group 1: inhalation and bathing the feet with the oil of Damask rose for 10 minutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital
Full name of responsible person
Nassime Setayesh vali pour
Street address
Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Younesian
Street address
Central Building of Tehran University of Medical Sciences, the Qods Street, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of nursing and midwifery, Tehran university of medical sciences
Full name of responsible person
Nassimeh Setayesh vali pour
Position
Senior midwifery student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tohid
City
Tehran
Postal code
Phone
+98 216822221
Fax
Email
setayesh_nassim64@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)