Background Sleep disorders are particularly common among primiparous women and in the last trimester of pregnancy. Unfortunately, there is no effective and systematic intervention method. This research was conducted to investigate the effects of pregnancy pillows used in the last trimester on sleep and comfort. Methods This study is an experimental randomized controlled trial. All stages of the study were reported and conducted according to CONSORT. The study was also registered on ClinicalTrials.gov with ID: NCT05790018. The study was conducted with two different groups (experimental and control). The study population consisted of primiparous pregnant women attending the outpatient clinic of Amasya Sabuncuoğlu Şerefeddin Training and Research Hospital between May and December 2023. The study was designed as a two-group (experimental and control) study. The sample size was determined using G*Power (version 3.1.9.7), assuming a medium effect size (Cohen’s d = 0.50), a significance level of 0.05, and a power of 80%. Considering possible data loss, the sample size was increased, and data were initially collected from 98 pregnant women. After exclusions, the study was completed with 75 pregnant women (38 in the experimental group and 37 in the control group). Randomization was performed using Random.org. Data were collected using a Personal Information Form, the Pittsburgh Sleep Quality Index (PSQI), and the Prenatal Comfort Scale (PCS). Results The mean PSQI score values showed a statistically significant difference across groups, regardless of time (p < 0.001). The mean PSQI score in the experimental group was 4.03, while the mean value in the control group was 8.12. A statistically significant difference was found between the mean PSQI score values across time periods, regardless of group (p = 0.039). The mean value obtained in the pretest was 5.57, the mean value obtained in the interim test was 6.04, and the mean value obtained in the posttest was 6.48. Lower PSQI scores indicate better sleep quality. The mean PCS score values showed a statistically significant difference across groups, regardless of time (p<0.001). The mean PCS score value was 65.7 in the experimental group, while the mean value was 50.9 in the control group. No statistically significant difference was found between the mean PCS score values across groups, regardless of time (p=0.100). Higher PCS scores reflect greater perceived comfort. Conclusion Compared with the control group, the experimental group showed significantly lower PSQI scores and higher PCS scores, indicating improved sleep quality and comfort with the use of a pregnancy pillow. Trial registration This study was registered at ClinicalTrials.gov ID: NCT05790018. (2025-02-17) Retrospectively registered. <a href="https://clinicaltrials.gov/study/NCT05790018">https://clinicaltrials.gov/study/NCT05790018</a>.

Effect of pregnancy pillow used in the last trimester on sleep and comfort: randomized controlled study

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2026年2月28日

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Betül Uzun Özer,
Hava Özkan

摘要

Background

Sleep disorders are particularly common among primiparous women and in the last trimester of pregnancy. Unfortunately, there is no effective and systematic intervention method. This research was conducted to investigate the effects of pregnancy pillows used in the last trimester on sleep and comfort.

Methods

This study is an experimental randomized controlled trial. All stages of the study were reported and conducted according to CONSORT. The study was also registered on ClinicalTrials.gov with ID: NCT05790018. The study was conducted with two different groups (experimental and control). The study population consisted of primiparous pregnant women attending the outpatient clinic of Amasya Sabuncuoğlu Şerefeddin Training and Research Hospital between May and December 2023. The study was designed as a two-group (experimental and control) study. The sample size was determined using G*Power (version 3.1.9.7), assuming a medium effect size (Cohen’s d = 0.50), a significance level of 0.05, and a power of 80%. Considering possible data loss, the sample size was increased, and data were initially collected from 98 pregnant women. After exclusions, the study was completed with 75 pregnant women (38 in the experimental group and 37 in the control group). Randomization was performed using Random.org. Data were collected using a Personal Information Form, the Pittsburgh Sleep Quality Index (PSQI), and the Prenatal Comfort Scale (PCS).

Results

The mean PSQI score values showed a statistically significant difference across groups, regardless of time (p < 0.001). The mean PSQI score in the experimental group was 4.03, while the mean value in the control group was 8.12. A statistically significant difference was found between the mean PSQI score values across time periods, regardless of group (p = 0.039). The mean value obtained in the pretest was 5.57, the mean value obtained in the interim test was 6.04, and the mean value obtained in the posttest was 6.48. Lower PSQI scores indicate better sleep quality. The mean PCS score values showed a statistically significant difference across groups, regardless of time (p<0.001). The mean PCS score value was 65.7 in the experimental group, while the mean value was 50.9 in the control group. No statistically significant difference was found between the mean PCS score values across groups, regardless of time (p=0.100). Higher PCS scores reflect greater perceived comfort.

Conclusion

Compared with the control group, the experimental group showed significantly lower PSQI scores and higher PCS scores, indicating improved sleep quality and comfort with the use of a pregnancy pillow.

Trial registration

This study was registered at ClinicalTrials.gov ID: NCT05790018. (2025-02-17) Retrospectively registered. https://clinicaltrials.gov/study/NCT05790018.