Sleep Clinical Trial
Official title:
Effect of Pregnant Pıllow Used ın the Last Trımester on Sleep and Comfort: Randomızed Controlled Study
Verified date | March 2023 |
Source | Amasya University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One of the most special life events of the fertile period is pregnancy. Pregnancy causes many physiological, metabolic, mental and social changes. These changes may adversely affect the sleep quality and comfort levels of pregnant women. Sleep is one of the basic life activities. Comfort is the state of being physiologically, mentally and socially comfortable. The woman who completes her pregnancy comfortably has a high self-confidence and quality of life. On the other hand, it is known that stress, anxiety and depression are experienced more and pregnancy and birth complications increase. For this reason, it is important to determine the comfort levels of pregnant women and to know the factors affecting them. It should not be forgotten that sleep quality in the prenatal period may be effective on the comfort levels of individuals. Evaluation of sleep quality and comfort levels of pregnant women is a routine part of prenatal care. Various interventions can be used to improve the sleep quality of pregnant women. The use of a pregnant pillow in the prenatal period is one of these applications. By providing support and relaxation to 5 different parts of the body simultaneously, the pregnancy pillow helps to increase the sleep quality of expectant mothers during pregnancy and to reduce the neck, abdomen, waist, back and leg pains they experience. It is known that sleep problems are experienced especially in primaries and third trimesters. For this reason, using the pregnant pillow in the third trimester, when sleep problems increase and comfort is adversely affected, may help improve the sleep quality and comfort level of pregnant women. With this planned study, it was aimed to examine the effect of the pregnant pillow used in the last trimester on sleep and comfort. This research will be carried out with pregnant women who applied to Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital NST and polyclinic unit between 01 March and 31 August 2023. The data of the study will be collected by using Personal Information Form, Information Form on Sleep in Pregnancy, Prenatal Comfort Scale and Pitsburg Sleep Quality Scale.
Status | Not yet recruiting |
Enrollment | 35 |
Est. completion date | May 13, 2024 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Volunteer to participate the study - Primiparous - 29-30. during pregnancy Exclusion Criteria: - Sleeping problems - Vision/mental diagnosed psychiatric problems |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amasya University | Ataturk University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prenatal comfort scale | The comfort is one of the primary outcomes. The comfort levels of pregnant women will be measured using the Prenatal Comfort Scale (PCS).
The PCS consists of 15 items and 5 sub-dimensions. The scale is evaluated over a total of 75 points. It is interpreted that as the score decreases, the comfort level also decreases, and as the score increases, the comfort level also increases. |
baseline and 4 weeks | |
Primary | Pittsburgh sleep quality index | Sleep quality is the other primary outcome for this study. Sleep quality of pregnant women will be evaluated with the Pittsburgh Sleep Quality Index (PSQI).
The PSQI assesses sleep quality and disturbance over the past month. The scale consists of 7 components. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality". |
baseline and 4 weeks | |
Primary | Prenatal Comfort Scale (PCS): 2 months | From the third trimester, pregnant women will be allowed to sleep on the pregnant pillow. At the end of the 2nd month, PCS will be repeated in order to determine the effect of the pillow used on the sleep and comfort of the pregnant women. | At the end of the 2 months | |
Primary | Pittsburgh Sleep Quality Index (PSQI): 2 months | From the third trimester, pregnant women will be allowed to sleep on the pregnant pillow. At the end of the 2nd month, PSQI will be repeated in order to determine the effect of the pillow used on the sleep and comfort of the pregnant women. | At the end of the 2 months |
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