Determining the effect of positive thinking training on the happiness of women with endometriosis referring to specialized gynecological clinics affiliated with Shiraz University of Medical Sciences
Design
Unblinded clinical trial, permutation random assignment to intervention and control groups, 82 sample subjects
Settings and conduct
Research setting: In the research settings of Shiraz Medical Sciences, participants are invited to participate in the study according to the entry and exit criteria and are divided into two intervention and control groups through permutation randomization. In the intervention group, after the pre-test, the intervention is carried out in the form of positive thinking training classes. Immediately and 4 weeks after the intervention, the relevant questionnaires are completed in the two groups and the data are analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Low happiness score according to the Oxford Happiness Questionnaire, married women of childbearing age living with their spouse... Exclusion criteria: Incomplete or non-completion of the questionnaire, unwillingness to continue participating in the research after entering the study or during follow-up...
Intervention groups
Intervention group: After the pre-test, the intervention will be conducted in the form of positive thinking training classes by the researcher in seven sessions, each session lasting 45-60 minutes, once a week. Control group: No intervention will be carried out, but at the end of the study, educational content will be provided to the control group in the form of a booklet to maintain educational justice.
Main outcome variables
Happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240507061690N4
Registration date:2025-08-01, 1404/05/10
Registration timing:prospective
Last update:2025-08-01, 1404/05/10
Update count:0
Registration date
2025-08-01, 1404/05/10
Registrant information
Name
Zahra Yazdanpanahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4256
Email address
yazdanz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-06, 1404/05/15
Expected recruitment end date
2025-11-06, 1404/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect Of Positive Thinking Training On The Happiness Of Women With Endometriosis
Public title
Investigating The Effect Of Positive Thinking Training On Women's Happiness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Low happiness score according to the Oxford Happiness Questionnaire
Married women of childbearing age who live with their husbands
A definitive diagnosis of endometriosis confirmed by ultrasound under the supervision of a specialist doctor
No surgical indications for the treatment of endometriosis
Willingness to participate in the research and complete the informed consent form
No diagnosis of other physical and mental illnesses such as diabetes, cardiovascular diseases, multiple sclerosis, and cancer that could affect the research results
Not using psychiatric medications, psychoactive substances, narcotics, or alcohol
Possessing at least basic literacy skills
No experience of bereavement in the past 6 months among first-degree relatives
Currently not pregnant or breastfeeding and has not been pregnant in the last two years
Exclusion criteria:
Incomplete or non-completion of the questionnaire
Unwillingness to continue participation in the research after entering the study or during follow-up
Failure to attend more than two sessions in the educational program
Death of a first-degree relative during the study
Undergoing surgery during the study
Age
From 10 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize, a method of permuted blocks will be used to allocate samples to two groups (intervention and control). A total of 84 samples will be placed in 14 blocks of 6. Ultimately, 42 individuals (7 blocks of 6) will be assigned to each group. The random allocation list of samples has been prepared using the Random Allocation software.
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 in Research of Nursing and Midwifery Faculties, Management and Medical Information
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2025-07-27, 1404/05/05
Ethics committee reference number
IR.SUMS.REC.1404.204
Health conditions studied
1
Description of health condition studied
Happiness
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Endometriosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Happiness score: Happiness in this study refers to the total score that women with endometriosis obtain by answering the standard Oxford questionnaire. A higher score indicates higher happiness in the individual and vice versa.
Timepoint
Before, immediately and 4 weeks after the intervention
Method of measurement
Happiness Scale Oxford Happiness Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, a pre-test is conducted in the intervention group, and demographic questionnaires and the Oxford Happiness Questionnaire are completed before the intervention in the intervention group. In the intervention group, after the pre-test, the intervention is carried out in the form of positive thinking training classes by the researcher in seven face-to-face sessions, each session lasting 45-60 minutes, once a week. The content of the training provided includes: stating the goals of the program, training in positive thinking and discovering positive beliefs (preparing a list of positive statements), discussing strengths and writing down three positive events in life, moderating negative thoughts, positive emotions, and providing supplementary activities, discussing gratitude and writing it down, defining happiness and ways to strengthen it, and giving participants a sense of worth. To complete the content of each session and further learn, participants in the intervention group will be given a booklet and asked to study the material related to each session before the start of the next session. After the intervention in the intervention group is completed, the Oxford Happiness Questionnaire will be reviewed by the participants twice, immediately and after 4 weeks of training.
Category
Other
2
Description
Control group: First, a pre-test is conducted in the control group, and demographic questionnaires and the Oxford Happiness Questionnaire are completed in the control group before the intervention. The control group, which entered the study at the same time as the intervention group, will be examined for happiness immediately and after 4 weeks of the intervention. It should be noted that no intervention will be performed in the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Zahra Yazdanpanahi
Street address
Namazi Square, Shiraz, Fars Provice
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 917 315 5992
Email
yazdanz@sums.ac.ir
2
Recruitment center
Name of recruitment center
Zeinabiyyeh Hospital
Full name of responsible person
Zahra Yazdanpanahi
Street address
Defae Moqadas Square, Shiraz, Fars Provice
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 917 315 5992
Email
yazdanz@sums.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Zahra Yazdanpanahi
Street address
Opposite Shahid Faghihi Street (Suratgar), Karim Khan Zand Boulevard, Shiraz, Fars Provice
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 917 315 5992
Email
yazdanz@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Vahid Hosseini
Street address
in front of Fars Regional Electric Company,next to Hazrat Fatima Al-Zahra Mosque, Karimkhan Zand Blvd,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Yazdanpanahi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh (PBUH), entrance of Namazi Hospital, Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
yazdanz@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Yazdanpanahi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh (PBUH), entrance of Namazi Hospital, Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
yazdanz@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Firoozeh Abolhasannezhad
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh (PBUH), entrance of Namazi Hospital, Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
firozehabolhasannezhad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Observance of ethical principles in the publication of the results (when publishing the study results, it will be avoided to provide any information that leads to the disclosure of people's information). • The results were published in such a way that the names of the participants will not be revealed
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The general results of the research will be provided to the research units and university officials
Under which criteria data/document could be used
Any copying of the entire thesis or part of it is allowed only with the supervisor's approval. • All intellectual rights of this work belong to Shiraz University of Medical Sciences and cannot be transferred to a third party without the written permission of the university. • It is not allowed to use the information and results in the thesis without mentioning the reference
From where data/document is obtainable
Study participants can be in contact with the researcher at all hours of the week and raise their questions and doubts. Address: Shiraz, Namazi Square, Faculty of Nursing and Midwifery. 09155650578 -- Firoozeh Abolhasannezhad
What processes are involved for a request to access data/document
Obtaining an official letter of introduction from Hazrat Fatemeh College of Nursing and Midwifery and obtaining permission from the Research Vice-Chancellor to access research documents from the Faculty and Shiraz University of Medical Sciences.