To assess the effect of positive thinking versus control group on stress and spermogram results on infertile men
Design
This is a randomized clinical trial, phase III, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible infertile men referring to the Fatemiah Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Infertility;
Abnormality of at least one of the semen parameters;
Monogamy;
Body mass index less than 30;
Exclusion criteria:
Using hormonal drugs;
Using traditional medicines to treat infertility;
Infertility-related organic disorders;
Drug or alcohol use;
Psychopathy;
Use of drugs that interfere with spermatogenesis such as methotrexate, nitrofurantoin, colchicine, and chemotherapy;
History of testicular surgery;
Contact with pesticides, heavy metals, and solvents;
Under diet for weight loss
Intervention groups
Intervention group:
Routine treatment plus positive thinking counseling 45-60-minute sessions weekly for a maximum of 8 sessions including (preparation; increasing knowledge and awareness; identifying personal abilities; reproductive ability; awareness of the impact of exercise, music, and meditation on body and spirit health; creating positive excitement and mentioning blessings; enjoying the present and good events in life and the joy of becoming a father and having a warm and intimate family; teaching lifestyle and life skills and improving relationships with others; increasing positive thinking)
Control group:
Just routine treatment
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of positive thinking versus control group on stress and spermogram results on infertile men: a randomized clinical trial
Public title
Effect of positive thinking versus control group on stress and spermogram results on infertile men
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Infertility;
Abnormality of at least one of the semen parameters;
Monogamy;
Body mass index less than 30;
Exclusion criteria:
Using hormonal drugs;
Using traditional medicines to treat infertility;
Infertility-related organic disorders;
Drug or alcohol use;
Psychopathy;
Use of drugs that interfere with spermatogenesis such as methotrexate, nitrofurantoin, colchicine, and chemotherapy;
History of testicular surgery;
Contact with pesticides, heavy metals, and solvents;
Under diet for weight loss
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action is repeated until the sample size is reached.
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-07-31, 1400/05/09
Ethics committee reference number
IR.UMSHA.REC.1400.353
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Semen parameters
Timepoint
Before intervention and 8 weeks later
Method of measurement
Using spermogram
2
Description
Stress
Timepoint
Before the intervention and 8 weeks later
Method of measurement
Using the Infertility Stress Questionnaire or Newton Infertility Problems
3
Description
Positive thinking
Timepoint
Before the intervention and 8 weeks later
Method of measurement
Using the Ingram and Wisnicki positive thinking questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus positive thinking counseling 45-60-minute sessions weekly for a maximum of 8 sessions including (preparation; increasing knowledge and awareness; identifying personal abilities; reproductive ability; awareness of the impact of exercise, music, and meditation on body and spirit health; creating positive excitement and mentioning blessings; enjoying the present and good events in life and the joy of becoming a father and having a warm and intimate family; teaching lifestyle and life skills and improving relationships with others; increasing positive thinking)
Category
Other
2
Description
Control group: Just routine treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiah Hospital in Hamadan city
Full name of responsible person
Maryam Eghbalian
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
eghbalianmaryam123@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Eghbalian
Position
MSc in Midwifery Consulting
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
eghbalianmaryam123@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Zahra Massumi
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available