Comparing the effect of mindfulness training with and without father participation on stress and parent-infant bonding in mothers of premature infants

To determine and compare the effect of mindfulness training with father participation and without father participation on stress levels and parent infant bonding among mothers of preterm infants hospitalized in the neonatal intensive care unit

Randomized clinical trial phase two with two parallel groups on eighty mothers of preterm infants the sample size is forty per group for randomization variable block randomization with sizes of six and nine using Stata software version seventeen was used blinding will be done for the data analyst.

This study will be conducted in the neonatal intensive care unit of a teaching hospital. The study population includes mothers of hospitalized preterm infants. Sampling is continuous and after obtaining informed consent, participants are allocated into two groups, mindfulness training with father participation and mindfulness training without father participation. The intervention includes mindfulness training sessions for mothers, with father participation in one group. Data are collected before and after the intervention. Due to the nature of the intervention, blinding of participants is not possible.

Inclusion criteria Mothers of hospitalized preterm infants; informed consent; no previous mindfulness training; no severe psychiatric disorder; ability to attend sessions. Exclusion criteria Lack of willingness to participate; presence of severe psychiatric disorder; use of psychoactive medication; inability to attend sessions.

Mindfulness training with father participation group; Mindfulness training without father participation group

Parental stress in the NICU; Parent–infant bonding

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.

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.