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IRCT20260419069104N1 IRCT 2026-06-14 Iran University of Medical Sciences Comparing the effect of mindfulness training with and without father participation on stress and parent-infant bonding in mothers of premature infants Comparing the effect of mindfulness training with and without father participation on stress and parent-infant bonding in mothers of premature infants 2026-07-06 anticipated 80 Recruiting https://irct.ir/trial/89662 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: We will use Variable Block Size Blocked Randomization to balance the number of group assignments at regular intervals (blocks) while minimizing the possibility of the researcher guessing the next assignment.Groups (K=2): - o A: Mindfulness training with father participation - o B: Mindfulness training without father participation - • Block sizes used: 6 and 9 are both multiples of 3 to maintain balance. - • Objective: Final allocation of 40 mothers (with a 15% dropout probability) to each group (total of 80 mothers). - The final allocation table will be created using a reliable statistical software (Stata17) and by randomly combining blocks of 6 and 9. This table contains 80 consecutive numbers from 1 to 80, each number assigned to one of the groups A or B. - Block size Distribution of groups in the block - 6 2 cases A, 2 cases B - 9 3 cases A, 3 cases B Allocation Concealment - To ensure no bias in the allocation process, the blinding process will be carried out as follows: - 1. The randomly generated sequence will be printed on 80 separate sheets, each sheet containing only the name of the allocated group A or B. - 2. Each sheet will be placed in an opaque envelope and the envelopes will be sealed and numbered sequentially from 1 to 80. 3. The sealed envelopes are kept by someone outside the research team who was responsible for sample recruitment. - 4. Each mother's group allocation will only be revealed after final verification of the inclusion criteria and informed consent, by opening the sealed envelope corresponding to her serial number. - This process ensures that the person responsible for enrolling and assessing mothers does not know the group she is allocated to before deciding to accept her into the study, which is one of the main pillars of quality clinical trials, Blinding description: Allocation Concealment - To ensure no bias in the allocation process, the blinding process will be carried out as follows: - 1. The randomly generated sequence will be printed on 80 separate sheets, each sheet containing only the name of the allocated group A or B. - 2. Each sheet will be placed in an opaque envelope and the envelopes will be sealed and numbered sequentially from 1 to 80. 3. The sealed envelopes are kept by someone outside the research team who was responsible for sample recruitment. - 4. Each mother's group allocation will only be revealed after final verification of the inclusion criteria and informed consent, by opening the sealed envelope corresponding to her serial number. - This process ensures that the person responsible for enrolling and assessing mothers does not know the group she is allocated to before deciding to accept her into the study, which is one of the main pillars of quality clinical trials. N/A Comparison of stress levels and parent-infant bonding in mothers of premature infants hospitalized in the neonatal intensive care unit who underwent mindfulness training with and without father participation.. Intervention 1: Intervention group: Mindfulness training with father participation. In this group, mothers receive mindfulness training in 8 sessions of 45 to 60 minutes. Fathers in this group have a supportive role by being present with mothers in face-to-face sessions and supporting them in doing mindfulness exercises. Data on the level of stress and parent-infant bonding are measured at three time points. T1: Before the intervention begins. T2: During the intervention (after the end of session 4). T3: After the end of the intervention (after the end of session 8). Intervention 2: Control group: Mindfulness training without father involvement. 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 Confidentiality and privacy
public Mahsa Shabani
Tehran, Vali Asr St., above Vanak Square, Rashid Yasemi St
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 8888 2886 MahsaShabani355@gmail.com Iran University of Medical Sciences scientific Mahsa Shabani
Tehran, Vali Asr St., above Vanak Square, Rashid Yasemi St.
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 8888 2886 MahsaShabani355@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Mothers with premature babies (delivered before 37 weeks) . A maximum of 3 days had passed since delivery at the time of the mother's entry into the study . The baby was hospitalized in the intensive care unit for at least 3 weeks The mother and father did not participate in mindfulness training courses The mother did not use sedatives and psychotropic drugs according to her self-report . Being literate to answer the questionnaires . Having Iranian nationality . Mothers had access to a smartphone. no limit no limit Both Lack of parental cooperation at any stage of the study . Early discharge of the infant from the hospital, which results in the mother not being available to continue the intervention Failure of the mother or father to attend more than one session of the educational program Sudden life-threatening event, such as grade 3 or 4 cerebral hemorrhage in the infant during the study Death of the infant during the study. N/A N/A Intervention group: Mindfulness training with father participation. In this group, mothers receive mindfulness training in 8 sessions of 45 to 60 minutes. Fathers in this group have a supportive role by being present with mothers in face-to-face sessions and supporting them in doing mindfulness exercises. Data on the level of stress and parent-infant bonding are measured at three time points. T1: Before the intervention begins. T2: During the intervention (after the end of session 4). T3: After the end of the intervention (after the end of session 8). Control group: Mindfulness training without father involvement Stress in mothers of premature babies. Timepoint: The outcome variables are measured at three time points as follows: 1. Pre-test phase: before the start of the training sessions (intervention). 2. Mid-phase: during the implementation of the intervention, immediately after the end of the fourth session. 3. Post-test phase: immediately after completing the training course (end of the eighth session). Method of measurement: Parental stress scale-PSS. Parent-infant-bound. Timepoint: This variable is measured at three time points: 1- Pre-test (before the start of the intervention) 2- During the intervention (after the end of the fourth session) 3- After the end of the intervention (end of the eighth session - post-test). Method of measurement: Parental-Infant Bonding Questionnaire. Iran University of Medical Sciences Approved 2026-06-03 Ethics Committee of the Iranian School of Nursing and Midwifery Tehran Province, Tehran, Rashid Yasemi St Tehran Tehran Iran (Islamic Republic of)