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IRCT20160821029446N14 IRCT 2025-11-18 Tehran University of Medical Sciences Investigating the effectiveness of mindfulness based intervention on perceived stress and emotional intimacy of infertile couples Investigating the effectiveness of mindfulness based intervention on perceived stress and emotional intimacy of infertile couples 2025-11-22 anticipated 48 Complete https://irct.ir/trial/81004 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Eligible individuals will be selected through convenience sampling and then assigned to the intervention and control groups using random block allocation with four-person blocks based on the sequences AABB, ABBA, ABAB, BBAA, BAAB, and BABA. In this method, the letter A represents the intervention group and the letter B represents the control group. All six permutations of the letters A, A, B, and B are written on six separate cards. Then, a number from 1 to 6 is randomly selected (using a random number table or by asking participant number 1 to randomly choose a card). For example, if number 2 is selected, it means that the first person will be assigned to the intervention group, the next two participants to the control group, and the fourth person to the intervention group. This process continues until the required sample size is reached. The intervention group will receive mindfulness training sessions in addition to routine infertility care, while the control group will receive only routine infertility care. N/A Perceived stress, emotional intimacy. Intervention 1: Intervention group: Counseling sessions for the research units in the intervention group will be held for 8 weeks, one session a week, for 90 minutes, and these sessions include meditation and stretching, focusing on breathing, body scanning practice, paying attention to reactions to thoughts and feelings. Intervention 2: Control group: During this period, the control group will not participate in any organized exercise program and will receive the center's routine care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Maryam Damghanian
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 Fnm@tumc.ac.ir Tehran University of Medical Sciences scientific Maryam Damghanian
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 fnm@tumc.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of infertility in couples according to the gynecologist's opinion The presence of both couples Having at least reading and writing literacy no limit no limit Both Using psychological treatments or drug therapy for mental health problems Lifestyle Lifestyle Intervention group: Counseling sessions for the research units in the intervention group will be held for 8 weeks, one session a week, for 90 minutes, and these sessions include meditation and stretching, focusing on breathing, body scanning practice, paying attention to reactions to thoughts and feelings. Control group: During this period, the control group will not participate in any organized exercise program and will receive the center's routine care. Perceived stress. Timepoint: Before the start of the intervention, immediately after the intervention, two months after the intervention. Method of measurement: To examine the perceived stress, the 4-question questionnaire of perceived stress by Cohen et al. (1983), which is a shortened version, will be used. This 4-question questionnaire (2 positive items and 2 negative items) measures thoughts and feelings about stressful events, control and coping with psychological pressure and stress experienced during the last month. The scoring method of the questionnaire is based on a 5-point Likert scale (never = 0, low = 1, medium = 2, high = 3, very high = 4). Questions 2 and 3 are scored inversely, the lowest score is zero and the highest score is 16. A higher score indicates greater perceived stress. Emotional intimacy. Timepoint: Before the start of the intervention, immediately after the intervention, two months after the intervention. Method of measurement: Another tool is Walker and Thompson's (1983) 17-question emotional intimacy questionnaire. This questionnaire is designed to measure intimacy based on a seven-point Likert scale (never = 1, rarely = 2, sometimes = 3, often = 4, mostly = 5, almost always = 6, always = 7). and a higher score means more emotional intimacy in couples. The test scores are obtained by summing the scores of the items and dividing it by the number 17. In this way, the minimum and maximum score of the subject is in the range of 1 to 7. Tehran University of Medical Sciences Approved 2024-11-20 Ethics committee of Tehran University of Medical Sciences Keshavarz Blvd., Qods St. intersection, Tehran University of Medical Sciences Central Building Tehran Tehran Iran (Islamic Republic of)