This research is a Randomize clinical trial, with the aim of determining the effect of honey syrup and date syrup on severity of physiologic labor pain and duration of active phase in nulliparous. In This study 120 healthy volunteered nulliparous women (40 in each group) with age 20-35 years, and with inclusion criteria, after reading and signing an informed consent will be participate, then will be randomly without replacement in one of three groups of honey syrup, date syrup and control. The honey syrup group will be given 2/5 dessertspoon of honey in 150 ml water and the date syrup group will be given mixture of 6 pieces of date in 150 ml water. The control group will receive only water as a routine. Interventions in both groups will be carried out during active phase (4-7 Cm dilatation) and will continue till 8 Cm Dilatation. labour care and control will be done based on National protocol of preparation for labour and delivery. For controlling the effect of environmental intervention such as noise effect, the study will be done in physiologic labour and delivery room, also for having same one to one care, all care and interventions will be done by same person and assistant will be assess pain. Pain will assess by visual numerical analogue scale (0-10) every 30 minutes.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201405182172N16
Registration date:2015-03-15, 1393/12/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Simin Taavoni
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 8161
Email address
staavoni@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Faculty of Nursing and Midwifery, Tehran University of Medical Sciences (Thesis)
2- Research Institute for Islamic and Complementary Medicine (RICM), Iran University of Medical Sciences (proposal)
Expected recruitment start date
2014-07-20, 1393/04/29
Expected recruitment end date
2014-12-20, 1393/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The therapeutic effect of oral honey syrup and date syrup on severity of labor pain and duration of active phase in nulliparous
Public title
Effect of oral Honey syrup and date syrup on labor pain and duration of active phase in nulliparous
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age 20 - 35 years old, with physical and mental health, no history of infertility, without history of allergy to honey and date, with 38-42 weeks of gestational age, cephalic presentation, with physiological labor and delivery conditions, with 4-7 Cm cervical dilatation.
Exclusion criteria: Unwillingness to continuing of cooperation in the study, due to maternal/placental or fetal factors entering to conditions of non physiological labor and delivery, more than six hours after membrane rupture.
Age
From 20 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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Dr Mirkhany St (N.East), Tohid Square
City
Tehran
Postal code
1419733171
Approval date
2014-12-07, 1393/09/16
Ethics committee reference number
9111373029-132686
Health conditions studied
1
Description of health condition studied
Labour pain management
ICD-10 code
XV Pregnan
ICD-10 code description
080-084 Delivery
Primary outcomes
1
Description
Pain
Timepoint
Every 30 minutes
Method of measurement
Visual analogue scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Honey syrup, 2/5 dessertspoon of honey in 150 ml water.
Category
Other
2
Description
Date syrup, mixture of 6 pieces of date in 150 ml water.
Category
Other
3
Description
Control, will receive only water
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Charity Hospital of Asali, Lorestan University of Medical Sciences
Full name of responsible person
Dr Norollah Moridi
Street address
Ghazi Abad St, Khoram Abad
City
Khoram Abad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences (Thesis)
Full name of responsible person
Dr Mohammad Ali Cheraghi
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Dr Mirkhany St (N.East), Tohid Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences (Thesis)
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine (RICM), Iran University of Medical Science
Full name of responsible person
Dr Seid Ashraf Aldin Gooshe gir
Street address
No9, Pirnia 1 Alley, North lalezar St, Jomhoori Islamic St, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine (RICM), Iran University of Medical Science
Proportion provided by this source
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
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
B. Sc in Midwifery, M.Sc in Midwifery Education. M.Sc in Medical Education, PhD student in Medical
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University of Medical, In opposition of Khatamol Anbia Hospital ,Rashid Yasami St., Valiaasr Ave.
City
Tehran
Postal code
1996713883
Phone
+98 21 8820 8161
Fax
+98 21 8820 1978
Email
staavoni14@yahoo.com
Web page address
staavoni@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
B. Sc in Midwifery, M.Sc in Midwifery Education. M.Sc in Medical Education, PhD student in Medical
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University of Medical, In opposition of Khatamol Anbia Hospital ,Rashid Yasami St., Valiaasr Ave.
City
Tehran
Postal code
1996713883
Phone
+98 21 8820 8161
Fax
+98 21 8820 1978
Email
staavoni14@yahoo.com
Web page address
staavoni@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
B. Sc in Midwifery, M.Sc in Midwifery Education. M.Sc in Medical Education, PhD student in Medical
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University of Medical, In opposition of Khatamol Anbia Hospital ,Rashid Yasami St., Valiaasr Ave.
City
Tehran
Postal code
1996713883
Phone
+98 21 8820 8161
Fax
+98 21 8820 1978
Email
staavoni14@yahoo.com
Web page address
staavoni@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)