The purpose of this study is to examine the effects of acute stress on declarative memory reconsolidation during the menstrual cycle in healthy woman. Fifty-six healthy female students of Semnan University of Medical Sciences with naturally menstrual cycle participate in this placebo-controlled, crossover study. Participants randomly assign to eight groups according to the factors assignment (High Progesterone vs. Low Progesterone) and (Reactivation vs. No Reactivation) and (Stress vs. Control): 1. High Progesterone /Reactivation/Stress 2. High Progesterone/Reactivation/Control 3. High Progesterone/No Reactivation/Stress
4. High Progesterone/No Reactivation/Control
5. Low Progesterone/Reactivation/Stress 6. Low Progesterone/Reactivation/Control 7. Low Progesterone/No Reactivation/Stress
8. Low Progesterone/No Reactivation/Control
Participants will test on three consecutive days; day 1: Learning; day 2: Memory Reactivation; and day 3: Retrieval and Recognition tests. After 2 months, participants return for days 4, 5, and 6, during which the same procedures will repeat with the alternate condition (Stress or Control) counterbalanced among participants. Menstrual status for each participant will determine by self-report and salivary progesterone levels that verifying to be within the expected range for the reported phase.
28 participants are in the follicular phase (Low progesterone), and 28 in the mid-luteal phase (High progesterone). In the stress groups, participants expose to the socially evaluated cold pressor test (SECPT) on day 2, after reactivation or no reactivation according to the corresponding group. Blood pressure and salivary cortisol will be measured to verify the efficacy of the SECPT.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052515975N1
Registration date:2014-06-17, 1393/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-17, 1393/03/27
Registrant information
Name
Mohsen Pourazizi
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 1445 1385
Email address
m.pourazizi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of acute stress on declarative memory reconsolidation across menstrual cycle in healthy women
Public title
Effects of acute stress on declarative memory reconsolidation across menstrual cycle
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion Criteria: Age between 18 and 25 years; Body mass index (BMI) between 19 and 26 kg/m2; No smoking; No addiction to narcotic substance and alcohol; No reported history of disease or psychiatric problems; No medication intake; No use of psychotropic drugs; No history of disease or abnormal laboratory test; Not being in stressful situations; Having a positive mood (According to PANAS); Naturally cycling with menstrual cycles between 24 and 32 days; Consent to participate in the study.
Exclusion Criteria: Being in stressful situations or disease during study.
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Postal code
Approval date
2013-11-27, 1392/09/06
Ethics committee reference number
92.372172
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
Z73.3
ICD-10 code description
Stress, not elsewhere classified
Primary outcomes
1
Description
Memory retrieval
Timepoint
Day 3
Method of measurement
Number of recalled pictures
Secondary outcomes
1
Description
Salivary cortisol level
Timepoint
S1: Day 2, Before SECPT or Control condition (Base); S2: Day 2, 10 minutes after SECPT or Control ; S3: Day 2, 25 minutes after SECPT or Control; S4: Day 2, 60 minutes after SECPT or Control; S5: Day 3, Before retrieval test.
In stress condition, participants expose to the socially evaluated cold pressor test (SECPT). Subjects will ask to immerse their right hand up to and including the wrist into ice water (0-2 C). Subjects would be asking to remain immersed for 3 min, but tell that they are free to pull out at any time without penalty. During hand immersion they will videotaping, ask to look into the video camera and tell that these video recordings would be analyzed later for facial expression. The SECPT has been shown to elicit significant increases in cortisol and autonomic activity. In the control condition, individuals immerse their right hand up to and including the wrist for 3 min into warm water (35—37 ºC). They are not videotape.
Category
Other
2
Description
Memory Task. Day1: Learning; On day 1, participants learn 30 pictures include ten positive pictures (such as Ice cream), ten negative pictures (example Injury) and ten neutral pictures(glass). Day2: Reactivation; On day 2, participants in reactivation group would be asked to remind the pictures they had learned on the previous day. In no reactivation group, participants reading newspaper. Immediately, they are challenging with Stress or Control. Day3: Retrieval and Recognition; On day 3, participants would be asked to write down the pictures they had learned on day 1. Cued recall will be assessed immediately after free recall. After 2 months, participants return for days 4, 5, and 6, during which the same procedures with the alternate condition (Stress or Control).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiology Research Center, Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Pourazizi
Street address
Semnan University of Medical Sciences, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Full name of responsible person
Dr. Raheb Ghorbani
Street address
Research and Technology Deputy of Semnan University of Medical Sciences, Basij Boulevard, Semnan, Iran
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences, Semnan, Iran
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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Pourazizi
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of medicine, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 1335 4359
Fax
Email
m.pourazizi@yahoo.com ; m.pourazizi@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physiology Research Center, Semnan University of Medical Sciences
Full name of responsible person
Dr.Ali Rashidy-Pour
Position
Ph.D, Professor of Physiology
Other areas of specialty/work
Street address
Laboratory of Learning and Memory, Physiology Research Center, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 1335 4359
Fax
Email
rashidy-pour@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Pourazizi
Position
Medical Student
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Semnan
City
Semnan
Postal code
Phone
+98 23 1335 4359
Fax
Email
m.pourazizi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)