The effect of a Neuman Systems Model-based intervention on anxiety and sleep quality among nulliparous pregnant women: a randomized controlled trial

Significant anxiety and sleep disturbances are common during pregnancy, especially for nulliparous women, and they can lead to adverse outcomes for both the mother and the fetus. The purpose of this study was to determine the effect of nursing intervention based on the Neuman Systems Model on the anxiety and quality of sleep of pregnant nulliparous women. Eighty nulliparous women who were referred to comprehensive health service centers in Khoy city participated in this randomized controlled trial. Participants were randomly assigned to either: the intervention group ( n = 40) and the control group ( n = 40). The Neuman Systems Model-based intervention for the intervention group included four counseling sessions with an emphasis on primary, secondary, and tertiary prevention. Regular prenatal care was given to the control group. The Pittsburgh Sleep Quality Index (PSQI) and the Spielberger State-Trait Anxiety Inventory were used to gather data at baseline and two weeks after the intervention. Both independent and paired t-tests were used to analyze the data. At baseline, the two groups were homogeneous regarding demographic variables, anxiety levels, and sleep quality ( p > 0.05). Following the intervention, the mean scores of state anxiety (34.15 ± 8.82 vs. 48.88 ± 9.26, p < 0.001) and trait anxiety (40.80 ± 7.57 vs. 45.83 ± 7.53, p = 0.004) were significantly lower in the intervention group compared to the control group. Furthermore, the intervention group demonstrated a significant improvement in sleep quality (PSQI score: 4.83 ± 2.85) compared to the control group (11.43 ± 2.68) ( p < 0.001). For nulliparous pregnant women, the Neuman Systems Model-based intervention is highly effective in reducing state and trait anxiety and enhancing sleep quality. It is advised to incorporate this thorough and feasible framework into standard prenatal treatment to empower women, improve their coping skills, and promote maternal mental health. Iranian Registry of Clinical Trials IRCT20250723066609N4. Registered on 2026-02-16.