The effect of physical activity intervention on mood, marital satisfaction, sexual self-concept and serotonin and adrenaline levels in women consumer birth control pills
1. Comparison the mean score of the Mood and Sexual Function Scale in women taking birth control pills
2. Comparison the mean score of sexual self-concept and marital satisfaction in women taking birth control pills
3. Comparison the average score of physical activity in women taking birth control pills
6. Comparison the mean laboratory of serotonin level in women taking birth control pills
7. Comparison the mean laboratory of adrenaline level in women taking birth control pills
Design
The randomized controlled trial .Study is not blind. The sample size was based on the probability of the first type error was α = 0.05 and the second type error was β = 0.2, and considering the 10% drop, a total of 70 people (35 in each group) were selected.
Settings and conduct
Individuals are randomly selected based on the list in 6 health centers.
The data of this study are analyzed by descriptive tests, correlation, regression, paired t-test.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age under 45 years
Minimum fifth grade education
Consumer of oral contraceptive pills
Lack of orthopedic problems and mood disorders
Exclusion criteria:
Absence of more than 2 sessions in the sports program
Stop taking birth control pills
Foot injury and immobility during the study
Intervention groups
Sports intervention:
Explain aerobic physical activity. The practical exercises are performed as follows:
3 sessions of aerobic exercise per week (warm-up, basic, cooling movements).
The duration of training in the first and second weeks is equal to 35-40 minutes, in the third and fourth weeks to 45-40 minutes and in the fifth and sixth weeks to 45-55 minutes.
For the control group, periodic routine care will be performed.
Main outcome variables
Changes in mood, marital satisfaction, sexual self-concept, serotonin and adrenaline levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180918041066N1
Registration date:2022-02-01, 1400/11/12
Registration timing:prospective
Last update:2022-02-01, 1400/11/12
Update count:0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Maryam Changizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5332 9306
Email address
mrs.changizi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-02, 1400/11/13
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physical activity intervention on mood, marital satisfaction, sexual self-concept and serotonin and adrenaline levels in women consumer birth control pills
Public title
The effect of physical activity intervention on mood, marital satisfaction, sexual self-concept, serotonin and adrenaline levels
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women referred and covered by the Comprehensive Health Service Cente
Ager under 45 years
Minimum fifth grade literacy
Consumer of oral contraceptive pills
Lack of orthopedic problems and mood disorders
Exclusion criteria:
Absence of more than 2 sessions in the sports program،
Stop taking birth control pills ،
Foot injury and immobility during the study
Age
To 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Among the urban health centers and 6 helth centers are randomly selected . Individuals are randomly selected based on the list of names in health centers .For random allocation using the 4-block method using random allocation software, subjects are divided into 2 groups of control and case.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Abadan School of Medical Sciences
Street address
Deputy of Education and Research, Next to Ayatollah Jami International Airport, Airport Square, Abadan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Approval date
2021-10-20, 1400/07/28
Ethics committee reference number
IR.ABADANUMS.REC.1400.105
Health conditions studied
1
Description of health condition studied
Psychological changes of birth control pills consumption
ICD-10 code
Z30.41
ICD-10 code description
Encounter for surveillance of contraceptive pills
Primary outcomes
1
Description
sexual self-concept,Mood (emotional state), marital satisfaction (assessing the happiness and stability of a marriage), serotonin or 5-hydroxytryptamine level (a monoamine with an important role in regulating the neurotransmitter of the neuro-hormonal system, adrenaline level.
Timepoint
Data will be collected before the intervention (pre-test) and 3 months after the intervention (post-test).
Method of measurement
Mood Questionnaire: Persian version of Bromez Mood status Questionnaire, Women's Sexual Function Scale (Questionnaire), Sexual Self-Concept (Questionnaire), Marital Satisfaction Questionnaire (Questionnaire), Short Form Physical Activity (IPAQ) (Questionnaire), Sertonin and Adrenaline (Blood test )
Secondary outcomes
1
Description
There study has no secondary consequence variable
Timepoint
zero
Method of measurement
No measurement
Intervention groups
1
Description
Intervention group: They will receive a sports activity program for several weeks. Before the study, a blood sample is measured to determine the levels of the hormones serotonin and adrenaline, and 3 months after the study, it will be re-evaluated along with other variables.
Category
Behavior
2
Description
Control group: For this group, periodic care related to the contraceptive pill user is performed
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center ,Abadan .Iran
Full name of responsible person
maryam changizi
Street address
Next to the Emergency Medical Center, Station no 10. Bahar St, Abadan, Iran.