Protocol summary

Study aim
Determining the effectiveness of mindfulness-based cognitive therapy (MBCT) on stress and life expectancy in infertile women undergoing acupuncture treatment.
Design
A randomized, double-blind, experimental and control clinical trial was conducted on 60 infertile women undergoing acupuncture treatment.
Settings and conduct
This research is conducted in the acupuncture clinic of Dr. Abbas Ansari in Tehran. Infertile women are enrolled in the study under acupuncture treatment. Considering that the women do not know about the group allocation, therefore, a blind strain study is performed. Then we will place them in two groups of 30 people randomly.
Participants/Inclusion and exclusion criteria
Entry criteria: infertile women aged between 20 and 40 years, diagnosed with infertility by a specialist doctor, receiving acupuncture treatment for infertility, ability and willingness to participate in a treatment intervention program, not having severe mental disorders. Exclusion criteria: presence of severe physical problems, use of psychotropic or antidepressant drugs, pregnancy or planning to become pregnant during the study period, and unwillingness to continue acupuncture treatment during the study period.
Intervention groups
The experimental group consists of infertile women undergoing acupuncture treatment who participate in the MBCT intervention program. The intervention consists of 8 90-minute group therapy sessions. Sessions are designed based on MBCT techniques, which include mindfulness exercises, meditation, and training to pay attention to current experiences. The control group receives no specific intervention and only uses standard acupuncture care. This group serves as a comparison group to evaluate the effects of MBCT intervention and its combination with relaxation exercises.
Main outcome variables
Stress and life expectancy in infertile women under acupuncture treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240623062228N1
Registration date: 2024-07-25, 1403/05/04
Registration timing: prospective

Last update: 2024-07-25, 1403/05/04
Update count: 0
Registration date
2024-07-25, 1403/05/04
Registrant information
Name
Arezou Nouri shafie
Name of organization / entity
Islamic Azad University, Semnan branch
Country
Iran (Islamic Republic of)
Phone
+98 21 3611 1111
Email address
arezounoori66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-27, 1403/05/06
Expected recruitment end date
2024-08-27, 1403/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of mindfulness based cognitive therapy (MBCT) on stress and life expectancy in infertile women undergoing acupuncture treatment
Public title
Investigating the effectiveness of mindfulness based cognitive therapy (MBCT) on stress and life expectancy in infertile women undergoing acupuncture treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with an age range of 20 to 40 years. Diagnosis of infertility by a specialist doctor. Receiving acupuncture treatment for infertility. Ability and willingness to participate in 8 cognitive therapy intervention sessions based on mindfulness. Not having diagnosed severe mental disorders (such as schizophrenia, bipolar disorder). Ability to read and write in order to fill out questionnaires and do homework. Written consent to participate in the study and follow the research instructions.
Exclusion criteria:
Existence of severe physical problems that prevent regular attendance at meetings. Currently taking psychotropic or antidepressant medications. Pregnancy or planning to become pregnant during the study period. History of participating in similar cognitive therapy programs based on mindfulness in the past year. Unwillingness to continue acupuncture treatment during the study period. Inability to do mindfulness exercises due to cognitive or physical problems. Any other condition that the researcher considers to be an obstacle to effective participation in the study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, randomization method is used to assign infertile women to intervention and control groups. First, each participant receives a unique ID. These IDs are randomly written on cards and the cards are thrown into a large container. Then, the cards are shuffled and taken out in turn. Each ID is randomly assigned to different groups. To determine the intervention and control groups, the set of cards is divided into two groups and each group is randomly assigned to one of the groups. This process ensures that the allocation of participants to groups is done without prejudice and randomly, which reduces the possibility of bias in the research results.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, blinding is done in one way. In this way, the participants do not know the type of intervention they are receiving. For this purpose, all participants attend therapy sessions that are identical in appearance and physical environment. Therapists, aware of the type of intervention (MBCT or acupuncture alone), consistently administered the same modality for all groups, and there were no apparent differences between sessions for participants. In order to maintain blinding, information about the exact type of intervention is not provided to the participants. They are only informed that they are participating in a study to investigate the effectiveness of mindfulness-based cognitive therapy. Any additional explanation about the details of the treatments will not be given to the participants until the end of the study in order to reduce bias effects. This method helps to evaluate the obtained results without bias and more accurately.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Semnan Azad University
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.039

Health conditions studied

1

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

Primary outcomes

1

Description
Stress score
Timepoint
Before the start of the intervention (pre-test), after completing 8 sessions of the intervention (post-test), one month after the end of the intervention (follow-up).
Method of measurement
Newton et al. stress test (1999)

2

Description
Life expectancy score
Timepoint
Before the start of the intervention (pre-test), after completing 8 sessions of the intervention (post-test), one month after the end of the intervention (follow-up).
Method of measurement
Miller's Life Expectancy Test (1988)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 8 intervention sessions will be implemented based on the treatment plan of Williams et al (1952). This intervention consists of eight one-and-a-half-hour weekly group sessions. The main focus of this treatment is mindfulness exercises and paying attention to consciousness. Different mindfulness techniques are taught in each session and participants are asked to practice these techniques to learn them well. Also, home exercises are provided between sessions to help stabilize the treatment better. All questions and doubts of the participants will be answered between the sessions. This treatment period lasts for a total of two months and its purpose is to reduce stress and increase the life expectancy of these women.
Category
Treatment - Other

2

Description
Control group: It usually receives no intervention and serves as a comparison group. In other words, the control group will only receive the usual and standard care and will not benefit from the MBCT treatment program.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Abbas Ansari Acupuncture Clinic
Full name of responsible person
Abbas Ansari
Street address
Unit 1, First floor, No. 2526 (Building 790), In front of 10th South Gandhi Street, Above Hemet Bridge, Valiasr Street.
City
Tehran
Province
Tehran
Postal code
1435674511
Phone
+98 21 2676 7205
Email
info@doctoransari.ir
Web page address
https://doctoransari.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Shahab Moradi
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
shahabmoradi66@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Semnan branch
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
Islamic Azad University, Semnan branch
Full name of responsible person
Arezou Nouri shafie
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
1st floor, No. 31, South Ofogh Alley, 20 meters of Dolat St.
City
Varamin
Province
Tehran
Postal code
3371965635
Phone
+98 21 3611 1111
Email
arezounoori66@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Maryam Salehyan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
arezounoori66@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Arezou Nouri shafie
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
1st floor, No. 31, South Ofogh Alley, 20 meters of Dolat St.
City
Varamin
Province
Tehran
Postal code
3371965635
Phone
+98 21 3611 1111
Email
arezounoori66@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Since the research plan is related to a thesis, only the study protocol, clinical study report, and study results will be published. The participant data file contains information about the participants, and due to the preservation of individuals' privacy it cannot be published.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The stages of the clinical study, such as the number of participants, the criteria for entering and exiting the research project, the sampling method, the treatment protocol, and the results of the study will be described in the thesis and article.
When the data will become available and for how long
Data can be made available 6 months after results are published.
To whom data/document is available
In research, access to data and documents is limited in order to protect the privacy and confidentiality of the participants. People who are allowed to access data and documents are: principal researchers and research collaborators, ethical supervisors and ethics review committees, colleagues and specialized consultants, researchers in scientific and academic centers and legal supervisors (if the research requires approval or supervision legal, legal observers may have access to data and documents). To access data and documents, all these people must respect the principles of confidentiality and privacy of the participants and only have access to the data they need to perform their duties.
Under which criteria data/document could be used
Using data to analyze and review research results and answer research questions, writing scientific articles, reports and presentations in conferences and authoritative publications, improving research methods and processes in future research, supporting decisions at the policy level and implementing operational plans. Using data as educational resources to educate students and researchers while maintaining the privacy and confidentiality of research participants' information.
From where data/document is obtainable
If you need the data, write to arezounoori66@gmail.com.
What processes are involved for a request to access data/document
After receiving the request and reviewing it by the main researcher, the data will be sent to the requester within a week, along with an undertaking that the data will not be published without the name of the main researcher and that the privacy and confidentiality of the research participants will be preserved.
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