The aim of the study: Comparison of the effect of acupuncture on preoperative anxiety in pregnant women candidate for elective cesarean section. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be randomly allocated into intervention and control group. Randomization will be performed using random block sizes of 4. The study is randomized, single-center. Inclusion criteria: Pregnant women candidate for elective cesarean section. Exclusion criteria: Opium addiction; history of chronic disease. Sample size: 100 patients are participated in the study with 50 patients in each group. The intervention used in the study: 5-7 sterile acupuncture needle with sizes 13-15 or 25 . Primary outcome: Rate of anxiety
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053034237N1
Registration date:2017-06-05, 1396/03/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-05, 1396/03/15
Registrant information
Name
Mehrasa Heydari
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 4530
Email address
m.heydari@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Islamic Azad University of Shahrood
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A sham-controlled trial of acupuncture on preoperative anxiety in pregnant women candidate for elective cesarean section
Public title
The effect of acupuncture on preoperative anxiety in pregnant women candidate for elective cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women candidate for elective cesarean section
Exclusion criteria: Opium addiction; history of chronic disease
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be performed using random block sizes of 4
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Shahrood
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Approval date
2017-03-09, 1395/12/19
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1395.22
Health conditions studied
1
Description of health condition studied
anxiety before cesarean section
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after the intervention
Method of measurement
Amsterdam Anxiety questionnier
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Inserting 5-7 sterile acupuncture needle with sizes 13-15 or 25 on true acupoints and maintaining them for 25-30 minutes
Category
Treatment - Drugs
2
Description
Control group: Inserting 5-7 sterile acupuncture needle with sizes 13-15 or 25 on superficially not in real acupuncture points and maintaining them 25-30
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
khatam Alanbia Hospital of Shahrood
Full name of responsible person
Yousef Kolukhi
Street address
khatam Alanbia Hospital, Tehran Blvd, Shahrood
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Sahebali Manafi
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
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 and Technology, Islamic Azad University of Shahrood
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
Islamic Azad University of Shahrood
Full name of responsible person
Mehrasa Heydari
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
m.heydari@iau-shahrood.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Yousef Kolukhi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
dr.yousefkolookhi.anesthezia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Yousef Kolukhi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)