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IRCT20260814070641N1 IRCT 2026-10-13 Shiraz University of Medical Sciences A Comparison of the effect of expressive writing and music therapy on distress tolerance and maternal role adaptation A Comparison of the effect of expressive writing and music therapy on distress tolerance and maternal role adaptation in mothers of preterm Infants hospitalized in neonatal intensive care units of hospitals affiliated with Shiraz University of Medical Sciences, 2025-2026 2026-10-11 anticipated 90 Recruiting https://irct.ir/trial/92512 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: To randomly assign samples to the two test and control groups, a random allocation method using permuted blocks with a block size of 4 was used. Accordingly, 19 four-unit blocks were designed to maintain balance in the number of samples in each group and reduce the probability of bias. Randomization procedure in the software: After entering the website https://www.sealedenvelope.com/simple-randomiser, the number of groups was set to 2 (test and control), the allocation ratio to 1:1, the randomization method to "Permuted blocks," and the block size to 4. Then, by defining 19 blocks, the allocation list was automatically generated and downloaded by the software. This software uses a cryptographically secure random number generator, which minimizes the predictability of the allocation sequence. The order of group allocation in each block was determined randomly, and the final allocation list was attached to the proposal as an appendix. This method allows the researcher to maintain relative balance between the groups at all stages throughout the sampling process. N/A Condition 1: distress tolerance. Condition 2: maternal role adaptation. Intervention 1: Intervention group : expressive writing - Participants wrote about their thoughts, mental ruminations, concerns, and related content using paper and pen provided by the researcher to the mothers in this group. This intervention consisted of six 15- to 20-minute sessions conducted over a period of two weeks (every other day). The sessions were held in a quiet, private room to facilitate greater concentration and relaxation for the mothers. Intervention 2: The intervention group received a music therapy protocol, in which mothers listened to six musical pieces selected by a music specialist using headphones in a quiet, private room. The pieces consisted of three Iranian and three classical Western compositions. This intervention was delivered over six sessions, each lasting 15 to 20 minutes, conducted over a period of two weeks (every other day). Intervention 3: Control group: In the control group, participants will receive only the routine and standard care of the neonatal intensive care unit, and no supplementary or additional intervention will be provided to them. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information is available
public Mitra Soltanian
Namazi
Shiraz Iran (Islamic Republic of) 71936131189 +98 71 3222 0078 Mitsoltan@yahoo.com Shiraz University of Medical Sciences scientific Neda Jamali Moghaddam
Namazi
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4254 nedajamali21@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Maternal age over 18 years Preterm birth (gestational age < 37 weeks) Minimum literacy level of the mother to complete the questionnaires (ability to read and write) No history of psychiatric disorders or use of related psychiatric medications (based on self-report), and no chronic physical illnesses Singleton pregnancy No prior history of preterm delivery Hospitalization of the infant for at least 14 days 18 years no limit Female Mothers other than those in the neonatal ward Mothers of infants admitted to other hospitals Behavior Behavior N/A Intervention group : expressive writing - Participants wrote about their thoughts, mental ruminations, concerns, and related content using paper and pen provided by the researcher to the mothers in this group. This intervention consisted of six 15- to 20-minute sessions conducted over a period of two weeks (every other day). The sessions were held in a quiet, private room to facilitate greater concentration and relaxation for the mothers. The intervention group received a music therapy protocol, in which mothers listened to six musical pieces selected by a music specialist using headphones in a quiet, private room. The pieces consisted of three Iranian and three classical Western compositions. This intervention was delivered over six sessions, each lasting 15 to 20 minutes, conducted over a period of two weeks (every other day). Control group: In the control group, participants will receive only the routine and standard care of the neonatal intensive care unit, and no supplementary or additional intervention will be provided to them. Mean score of distress tolerance based on the Distress Tolerance Scale (DTS) by Simons and Gaher. Timepoint: Measurement of distress tolerance score at baseline, immediately after the intervention, and one week after the intervention. Method of measurement: Simons & Gaher Distress Tolerance Scale. Mean score of maternal role adaptation based on the Maternal Role Adaptation Questionnaire in Mothers of Preterm Infants (Heydarpour et al., 2016). Timepoint: Measurement of maternal role adaptation score at baseline, immediately after the intervention, and one week after the intervention. Method of measurement: Maternal Role Adaptation Questionnaire in Mothers of Preterm Infants (Heydarpour et al., 2016). Shiraz University of Medical Sciences Approved 2026-07-04 Ethics committee of Shiraz University of Medical Sciences Namazi Square - Hazrat Fatemeh (S) School of Nursing and Midwifery shiraz Fars Iran (Islamic Republic of)