Midwifery · 2026
Effects of Kolcaba's comfort theory-based breathing awareness intervention initiated in the second trimester on third-trimester comfort in primiparous women: a randomised controlled trial.
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Küçük Sibel, Sevil Ümran, Sak Sibel
Аннотация
INTRODUCTION: This study aimed to examine the effect of a theory-informed breathing awareness intervention initiated in the early second trimester on third-trimester comfort levels among primiparous pregnant women. Although breathing-based interventions have been shown to improve maternal well-being, evidence on the sustained effects of theory-based interventions initiated earlier in pregnancy remains limited.
METHODS: This single-blind randomised controlled trial was conducted with primiparous pregnant women attending the obstetrics and gynecology outpatient clinic of a university hospital in Turkey. The intervention group performed daily breathing awareness intervention for eight weeks starting in the early second trimester, while the control group received routine antenatal care. Data were collected using the Descriptive Information Form and the General Comfort Scale (GCS). Statistical significance was set at p < 0.05.
RESULTS: The study was completed with 71 participants (intervention n = 35; control n = 36). Groups were comparable at baseline (p > 0.05). After the intervention, total GCS scores were significantly higher in the intervention group (p < 0.001), with a large effect size (Cohen's d = 1.35; 95 % CI: 11.52-23.50). Significant improvements were observed in the physical, psychospiritual, and environmental sub-dimensions (p < 0.05), but not in the sociocultural dimension (p > 0.05). Significant between-group differences were also found in pulse rate (p = 0.033; d = -0.54), respiratory rate (p < 0.001; d = -1.07), and oxygen saturation (p < 0.001; d = 2.81), all favoring the intervention group. Although systolic blood pressure decreased within the intervention group (p < 0.001), the between-group difference was not significant (p = 0.065).
CONCLUSIONS: Breathing awareness intervention initiated in the early second trimester and structured within Kolcaba's Comfort Theory was associated with improved maternal comfort and selected physiological parameters in late pregnancy, suggesting that it may be a useful non-pharmacological supportive approach in antenatal care.
TRIAL REGISTRATION: The study protocol was registered at ClinicalTrials.gov (NCT06520930) prior to participant recruitment.
METHODS: This single-blind randomised controlled trial was conducted with primiparous pregnant women attending the obstetrics and gynecology outpatient clinic of a university hospital in Turkey. The intervention group performed daily breathing awareness intervention for eight weeks starting in the early second trimester, while the control group received routine antenatal care. Data were collected using the Descriptive Information Form and the General Comfort Scale (GCS). Statistical significance was set at p < 0.05.
RESULTS: The study was completed with 71 participants (intervention n = 35; control n = 36). Groups were comparable at baseline (p > 0.05). After the intervention, total GCS scores were significantly higher in the intervention group (p < 0.001), with a large effect size (Cohen's d = 1.35; 95 % CI: 11.52-23.50). Significant improvements were observed in the physical, psychospiritual, and environmental sub-dimensions (p < 0.05), but not in the sociocultural dimension (p > 0.05). Significant between-group differences were also found in pulse rate (p = 0.033; d = -0.54), respiratory rate (p < 0.001; d = -1.07), and oxygen saturation (p < 0.001; d = 2.81), all favoring the intervention group. Although systolic blood pressure decreased within the intervention group (p < 0.001), the between-group difference was not significant (p = 0.065).
CONCLUSIONS: Breathing awareness intervention initiated in the early second trimester and structured within Kolcaba's Comfort Theory was associated with improved maternal comfort and selected physiological parameters in late pregnancy, suggesting that it may be a useful non-pharmacological supportive approach in antenatal care.
TRIAL REGISTRATION: The study protocol was registered at ClinicalTrials.gov (NCT06520930) prior to participant recruitment.