Clinical trial NCT06200428: The Effect of the Pregnancy Pillow Used in the Last Trimmester on Fatigue and Comfort
Official title: The Effect of the Pregnancy Pillow Used in the Last Trimmester on Fatigue and Comfort: Randomized Controlled Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Support Pillow
Keywords: Pregnancy
sleep support pillow
sleep
fatigue
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Detecting fatigue experienced during pregnancy and intervening with an effective intervention has an important place in both improving the comfort during pregnancy and the healthy progress of pregnancy, birth and postpartum period. Determining the severity of fatigue experienced during pregnancy and identifying risk factors can help midwives design adequate and effective interventions for pregnant women in this sensitive period (Çoban \& Yanıkkerem, 2010; Türkmen, 2014).

The planned research was aimed to examine the effect of the pregnancy pillow used in the last trimester on fatigue and comfort.

Detailed description: Pregnancy is a natural and physiological event. However, the physiological, psychological and metabolic changes that occur in this process may bring about some disorders (Şahin \& Kiliçarslan, 2010; Yanikkerem, Altiparmak, \& Karadenİz, 2006). Disorders that occur during this period may differ depending on the week of pregnancy. In the first trimester, breast tenderness, nausea-vomiting, frequent urination; in the second trimester; Constipation, headache, increased appetite, back pain and fatigue may occur (Aydın Özkan, Kaya Şenol, \& Aslan, 2020). In the third trimester, due to changing anatomical and physiological changes, edema, frequent urination, muscle cramps, lower back pain, insomnia, shortness of breath, weakness and fatigue may be observed (Aydın Özkan et al., 2020). Fatigue is a condition that is frequently seen, especially in the third trimester of pregnancy, and has an impact on the ability to continue activities of daily living. Although the real cause is unknown, fatigue and weakness can occur in any period of pregnancy. It has also been stated in the literature that it may cause labor pain or postpartum depression (Mortazavi \& Borzoee, 2019). Therefore, preventing fatigue during pregnancy is very important.

Comfort is the state of being stress-free and comfortable physiologically, spiritually and socially (Kolcaba \& Dimarco, 2005). A woman who completes her pregnancy comfortably has a high sense of self-confidence and quality of life. In the opposite case, it is known that stress, anxiety and depression are experienced more and pregnancy and birth complications increase (Nakamura et al., 2015). Therefore, it is important to determine the comfort levels of pregnant women and know the affecting factors (Aydın Özkan et al., 2020).

Midwives have important duties to improve maternal and indirectly public health by reducing pregnancy problems experienced by women. Midwives should not only provide physical care to pregnant women during prenatal care. Midwives must also fulfill their roles and responsibilities of observation, support, assistance, continuing education and consultancy. Midwives should carefully listen to the symptoms and problems stated by the pregnant woman and determine the extent of the problems. One of the most important problems experienced during pregnancy is fatigue (Cheng et al., 2015; Çoban \& Yanıkkerem, 2010; Perry et al., 2014). However, unfortunately, there is no systematic intervention to prevent or treat fatigue experienced during pregnancy.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age,
* Volunteer to participate in the research,
* Primiparous,
* 29-30. week of pregnancy,
* Speaks Turkish,
* At least primary school graduate,
* It is planned to include pregnant women who do not have any chronic, visual/mental or diagnosed psychiatric problems and who do not use medication.

Exclusion Criteria:

* Younger than 18,
* Those who do not volunteer to participate in the research,
* Multiparous,
* Less than 29 weeks,
* Those who do not speak Turkish,
* Illiterate,
* It is planned to exclude pregnant women who have any chronic, visual/mental or diagnosed psychiatric problems and who use medication.

Primary outcomes:
measure: Prenatal comfort scale
timeFrame: baseline and 4 weeks
measure: Prenatal Comfort Scale (PCS): 2 months
timeFrame: At the end of the 2 months
measure: Chalder Fatigue Scale
timeFrame: baseline and 4 weeks
measure: Chalder Fatigue Scale
timeFrame: At the end of the 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: