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

December 28, 2023 updated by: Amasya University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group

First of all, the pregnant women included in the experimental group;

  • Survey forms and scales will be applied in the pre-test (in weeks 29-30).
  • Then, a pregnancy pillow will be given and necessary explanations will be given about its use.
  • Second follow-up 33-34. It will be done during the first week of pregnancy and the scales will be repeated.
  • The last test is 37-38. It will be done during the gestational week (before birth) and the research will be completed.
  • Pregnancy pillow provides support and relief to 5 different parts of the body simultaneously.
  • It protects the health of expectant mothers during pregnancy and helps reduce neck, abdominal, waist, back and leg pain.
  • It does not lose its shape, become felt or flat with use.
  • Thanks to its zipper, the cover can be easily removed and washed, and can be put on just as easily.
Other: sleep support pillow
A sleep support pillow will be used in this study.
No Intervention: Control group

To the pregnant women included in the control group, the researcher;

  • The survey forms and scales will be applied in the pre-test and no other intervention will be applied (in weeks 29-30).
  • Pregnant women in the control group were given 33-34 and 37-38 days. The last test will be done in a week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prenatal comfort scale
Time Frame: baseline and 4 weeks

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
Prenatal Comfort Scale (PCS): 2 months
Time Frame: At the end of the 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
Chalder Fatigue Scale
Time Frame: baseline and 4 weeks
The 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).
baseline and 4 weeks
Chalder Fatigue Scale
Time Frame: At the end of the 2 months
The 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).
At the end of the 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amasya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AmasyaU-betuluzun-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Support Pillow

Clinical Trials on sleep support pillow

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings