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IRCT20240623062228N1 IRCT 2024-07-25 Islamic Azad University, Semnan branch Investigating the effectiveness of mindfulness based cognitive therapy (MBCT) on stress and life expectancy in infertile women undergoing acupuncture treatment Investigating the effectiveness of mindfulness based cognitive therapy (MBCT) on stress and life expectancy in infertile women undergoing acupuncture treatment 2024-07-27 anticipated 40 Complete https://irct.ir/trial/77581 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Female infertility. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Arezou Nouri shafie
1st floor, No. 31, South Ofogh Alley, 20 meters of Dolat St.
Varamin Iran (Islamic Republic of) 3371965635 +98 21 3611 1111 arezounoori66@gmail.com Islamic Azad University, Semnan branch scientific Maryam Salehyan
Islamic Azad University, University Town, Semnan
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3365 4040 arezounoori66@gmail.com Islamic Azad University, Semnan branch Iran (Islamic Republic of) 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. 20 years 40 years Female 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. N97 Female infertility Treatment - Other Treatment - Other 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. 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. 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). 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). Islamic Azad University, Semnan branch Approved 2024-05-01 Ethics Committee of Semnan Azad University Islamic Azad University, University Town, Semnan Semnan Semnan Iran (Islamic Republic of)