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Investigating the effect of group meaning therapy intervention on the psychological well-being of infertile women

Protocol summary

Study aim
Determining the effect of group meaning therapy intervention on psychological well-being of infertile women in Qazvin city
Design
Clinical trial , Purposive sampling, With intervention and control parallel groups, Randomized, on 68 infertile women. For randomization, double and quadruple blocking was used in Excel software.
Settings and conduct
The research environment will be the infertility clinic of "Velayat hospital" and "Jahad daneshgahi" infertility center of Qazvin city. The study sample will be 68 infertile women. Eligible people will be registered through purposive sampling. The short form of Reef psychological well-being and demographic questionnaire will be provided to them. People who get a score less than 54 from the Reef questionnaire will be randomly allocated to two intervention and control groups (34 people in each group). The intervention group will receive 8 sessions of 90 minutes group and virtual meaning therapy intervention . The control group will not receive any intervention. Follow-up will be done immediately and two months after the intervention.
Participants/Inclusion and exclusion criteria
entry criteria: Being Iranian, female primary infertility, Tend to participate, minimal literacy, Score less than 54 on Reef questionnaire, Speak and understand Persian, Have a smartphone؛ Exit criteria: severe marital conflicts, participating in other psychological intervention , having mental illness, occurrence of stressful events In the last quarter
Intervention groups
The intervention group will receive 8 sessions of 90 minutes of virtual group meaning therapy intervention in "Google meet" or "Qarar" application, once a week, include each session content presentation, an educational booklet and other materials in the form of audio and videos. The control group receives only routine ward care and education.
Main outcome variables
Psychological well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240514061791N1
Registration date: 2024-08-14, 1403/05/24
Registration timing: prospective

Last update: 2024-08-14, 1403/05/24
Update count: 0
Registration date
2024-08-14, 1403/05/24
Registrant information
Name
mahya shokoohifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6625 9252
Email address
mahyashokohifard@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of group meaning therapy intervention on the psychological well-being of infertile women
Public title
Investigating the effect of group meaning therapy intervention on the psychological well-being of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian Suffering from primary infertility due to female causes Tending to participate in research Having at least the minimum of literacy Gaining a score less than 54 on Reef psychological well-being questionnaire Having ability to speak and understand Persian (Farsi) language Having a smartphone and access to the Google meet platform or Qarar application
Exclusion criteria:
presence of severe marital conflicts (according to the participant) participating in other psychological intervention sessions during the last six months Suffering from a known and diagnosed mental illness based on self-report and health records occurrence of stressful events In the last quarter
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Purposive sampling will be done in infertility clinic of "Velayat hospital" and "Jahad daneshgahi" infertility center in Qazvin city. People who have study entry criteria will be registered. Infertile women who have scored less than 54 from the Reef psychological well-being questionnaire and are willing to participate in the study will be randomly allocated to intervention and control groups in the next step. For random allocation, given that there is an intervention method (group meaning therapy) and two control and intervention groups and given that the randomization unit will be individual, random allocation sequence generation application will be used to determine the allocation sequence with binary and quadruple blocks methods. After determining the allocation sequence by binary and quadruple blocks in order to hide the allocation sequence, the sequence of blocks will be written on the papers specifying the group of people (control (C) and intervention (T)) and will be put respectively inside the closed and unspecified envelopes and entered into groups in the same order. If there is a significant difference in the two groups in terms of demographic information, the analysis of covariance test will be used to minimize the difference in the two groups.
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 the Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin City, Qazvin Province, Iran
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Approval date
2024-08-05, 1403/05/15
Ethics committee reference number
IR.QUMS.REC.1403.182

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
The score of psychological well-being of infertile women according to Reef psychological well-being questionnaire (PWBS)
Timepoint
once before beginning of study, once immediately after completion of the intervention, once two months after completion of intervention
Method of measurement
Reef psychological well-being questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After replacing the people in the intervention and control groups, people in the intervention group members will be divided into 4 groups of 7 people and one group of 6 people. The meaning therapy intervention will be done in 8 sessions of 90 minutes and one session per week, the first session will be held in person and individually in order to familiarize the members with the researcher, the process and goals of the research. The other sessions will be virtual and group and in application that is available for the participants ("Google meet" or "Qarar" application). In addition to the online meetings, a group will be formed in social media that is available for participants, after each meeting, their questions will be answered in this group. Researcher's personal number will be available for answering personal questions. Generally, intervention group will receive presentation of the content of meaning therapy in virtual form, the educational booklet and other materials as audios and educational videos that will be shared in the group in social media. The content of the sessions is as follows: The first session: Greeting with members, Familiarizing the members with infertility problems and psychological well-being concept, Introducing intervention "group meaning therapy", Familiarizing the members with the rules of the group. The second session: Creating self-awareness in people, Raising the concept of freedom and authority in life. The third session: Explaining choices responsibility. The fourth session: Recognition of existential anxiety, teaching strategies to deal with anxiety and controlling pessimistic thoughts. The fifth session: Finding meaning from life, Communication with others and Self-development. The sixth session: Examining the meaning of suffering as one of the meaningful aspects of life. The seventh session: Finding meaning through values. Eighth session: Finding meaning through explaining goals and self-improvement, Appreciation and thanks, post-test implementation. The content of the sessions will be presented based on Frankel's meaning therapy approach and Hatzel's plan.
Category
Treatment - Other

2

Description
Control group: In this study, the control group receives only the care and routine training of the ward. In order to comply with the ethical standards at the end of the research, the presented content will be available to the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
infertility clinic of Velayat hospital
Full name of responsible person
Mahya Shokoohifard
Street address
Velayat hospital, Taavon Square, 22 Bahman Blvd., Koi Elahih, Minodar town, Qazvin, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3379 0620
Email
mahyashokohifard@gmail.com

2

Recruitment center
Name of recruitment center
"Jahad daneshgahi" infertility center
Full name of responsible person
Mahya Shokoohifard
Street address
"Jahad daneshgahi" Infertility Center, between Azadi Square and Shahid Akhwan Nouri Fard, Ferdowsi St., Qazvin city, Qazvin province, Iran.
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3324 2335
Email
mahyashokohifard@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi Mirhashmi
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin City, Qazvin Province, Iran.
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
sm.mirhashemi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
1
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
Qazvin University of Medical Sciences
Full name of responsible person
Mahya Shokoohifard
Position
Master's student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin City, Qazvin Province, Iran.
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 21 6625 8677
Email
mahyashokohifard@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahya Shokoohifard
Position
Master's student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin City, Qazvin Province, Iran.
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 21 6625 8677
Email
mahyashokohifard@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahya Shokoohifard
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin City, Qazvin Province, Iran.
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 21 6625 8677
Email
mahyashokohifard@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
Anonymized coded data, research protocol, outcome information
When the data will become available and for how long
5 months after the publication of the results until one year
To whom data/document is available
Researchers, universities, institutions
Under which criteria data/document could be used
Receiving research data and information in order to design new research is unimpeded. Send an email to the responsible person. Response will be received within two weeks.
From where data/document is obtainable
Send an email to the responsible person. Response will be received within two weeks.
What processes are involved for a request to access data/document
Send an email to the responsible person. Response will be received within two weeks.
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