Skip to content

The Effect of the Pregnancy Pillow Used in the Last Trimmester on Fatigue and Comfort

The Effect of the Pregnancy Pillow Used in the Last Trimmester on Fatigue and Comfort: Randomized Controlled Study)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06200428
Enrollment
39
Registered
2024-01-11
Start date
2024-01-22
Completion date
2024-10-31
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Support Pillow

Keywords

Pregnancy, sleep support pillow, sleep, fatigue

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.

Interventions

OTHERsleep support pillow

A sleep support pillow will be used in this study.

Sponsors

Amasya University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prenatal comfort scalebaseline and 4 weeksThe 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.
Prenatal Comfort Scale (PCS): 2 monthsAt the end of the 2 monthsFrom 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.
Chalder Fatigue Scalebaseline and 4 weeksThe scale consists of 11 items in total, including a 7-item physical fatigue subsection and a 4-item mental fatigue subsection. The scale is a four-point Likert type; Less than usual = 0, as much as usual = 1, more than usual = 2, much more than usual = 3. Scoring of the scale can be done in two different ways. Frequently used; It is a scoring between 0-3 and the total score varies between 0-33. This option will be preferred when evaluating the data obtained from the research. In alternative scoring, the first two columns (less than usual, as much as usual) are scored as 0, and the last two columns (more than usual, much more than usual) are scored as 1. High scores indicate greater fatigue severity. When the Cronbach alpha value was examined, it was found that the overall scale had an acceptable level of internal consistency (Cronbach alpha = 0.70).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026