Clinical trial NCT05790018: Effect of Pregnant Pıllow on Sleep and Comfort
Official title: Effect of Pregnant Pıllow Used In the Last Trımester on Sleep and Comfort: Randomızed Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Sleep
Comfort
Keywords: Pregnancy
Pregnancy pillow
Sleep
Comfort
Lead sponsor: Amasya University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2023-03-29
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: To research Over 18 years of age Volunteer to participate in the research, Primiparous, 29-30. during pregnancy, Fluent in Turkish, At least primary school graduate, It is planned to include pregnant women who do not have sleep problems, visual/mental and diagnosed psychiatric problems and do not use medication.

Persons who do not meet these criteria and do not volunteer to participate in the study will not be included in the study.

Data Collection The pregnant women included in the study will be randomly assigned to the groups and homogeneity will be ensured in the distribution of the groups. "Random Allocation Software Program" will be used in the randomization of pregnant women into groups and a randomization list for the study will be created. If the pregnant woman leaves the study for any reason during the study, the first pregnant woman who meets the research criteria will be assigned to the other group in the randomization list.

Midwifery Initiative Midwifery Attempts Made to the Control Group The researcher will apply the questionnaires and scales in the pre-test to the pregnant woman included in the control group, and no other intervention will be applied. 37-38 to the pregnant women in the control group. The final test will be done weekly.

Midwifery Attempts Made to the Experimental Group First of all, questionnaire forms and scales will be applied to the pregnant women included in the experimental group in the pre-test (at 29-30 weeks). Then the pregnant pillow will be given and necessary explanations will be given about its use. Second follow-up 33-34. It will be done at the gestational week and the scales will be repeated. The final test is 37-38. It will be done at the gestational week (before birth) and the research will be completed.

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate the study
* Primiparous
* 29-30. during pregnancy

Exclusion Criteria:

* Sleeping problems
* Vision/mental diagnosed psychiatric problems

Primary outcomes:
measure: Prenatal comfort scale
timeFrame: baseline and 4 weeks
measure: Pittsburgh sleep quality ındex
timeFrame: baseline and 4 weeks
measure: Prenatal Comfort Scale (PCS): 2 months
timeFrame: At the end of the 2 months
measure: Pittsburgh Sleep Quality Index (PSQI): 2 months
timeFrame: At the end of the 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya Provincial Health Directorate Sabuncuoğlu Şerefeddin Training and Research Hospital
state: Center
Study officials:
References: