Effect of Pregnant Pıllow on Sleep and Comfort

NCT05790018 | Completed

• 1 other identifier: AmasyaU-betuluzun-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Sleep; Comfort

Keywords

Pregnancy; Pregnancy pillow; Sleep; Comfort

Outcome Measures

Primary Outcomes (4)

• 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

• Pittsburgh sleep quality ındex

  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

• 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

• 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

Study Arms (2)

Experiment

EXPERIMENTAL

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.

Device: PREGNANT PILLOW

Control

NO INTERVENTION

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.

Interventions

PREGNANT PILLOW DEVICE

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.

Experiment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteer to participate the study
• Primiparous
• during pregnancy

You may not qualify if:

• Sleeping problems
• Vision/mental diagnosed psychiatric problems

Sponsors & Collaborators

• Amasya University: lead
• Ataturk University: collaborator

Study Sites (1)

Amasya Provincial Health Directorate Sabuncuoğlu Şerefeddin Training and Research Hospital

Amasya, Center, 05000, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 29, 2023
• Study Start: May 2, 2023
• Primary Completion: December 30, 2023
• Study Completion: May 30, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: It will be published after the research is completed.
• Access Criteria: Subscribing to the journal in which the article was published

Locations

TU (1)