The Effect of Massage Ball Application on Blood Pressure, Fatigue and Anxiety in Pregnant With Preeclampsia

NCT ID: NCT06066411

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-07-19

Brief Summary

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The aim of this study is to determine the effect of massage ball application on arterial blood pressure, fatigue and anxiety in pregnant women diagnosed with preeclampsia.

Detailed Description

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Hypertensive disorders are one of the common disorders in pregnancy that cause complications in the mother and the fetus. Preeclampsia, one of the hypertensive disorders of pregnancy, is defined as the presence of hypertension, proteinuria or organ damage that occurs after the 20th week of pregnancy. Preeclampsia affects 5% to 7% of all pregnancies. It causes more than 70,000 maternal deaths and 500,000 fetal deaths worldwide each year. Preeclampsia is among the main causes of maternal mortality and morbidity. Preeclampsia is the first cause of maternal death due to hypertension. According to the report on causes of maternal death in our country, 14.2% of pregnant women died due to hypertensive diseases in 2019. Pregnancy-induced hypertension is the second leading cause of maternal deaths. Preeclampsia causes increased blood pressure in pregnant women, cardiovascular diseases, cerebrovascular accidents, and dysfunction in organs such as the liver, kidney and uterus. In addition to affecting the systems, it is also a condition that causes anxiety and fatigue in pregnant women. The most effective treatment for preeclampsia is delivery. In hospital, treatment includes MgSO4 therapy, blood pressure monitoring, urine monitoring, a high-protein and salt-restricted diet, and control of fetal movements and midwifery care to keep blood pressure at normal levels and prevent eclampsia. In addition to medical treatment in preeclampsia, complementary treatments such as music therapy, acupuncture and massage are also used. Massage application helps relax the muscles. It is stated that massage applied to pregnant women positively affects anxiety, blood pressure and fatigue. Equipment such as tennis ball, golf ball and massage ball are used for muscle relaxation. It is thought that massage ball application, one of the methods used in massage, will reduce anxiety, fatigue and be effective in lowering blood pressure.

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups with a massage ball group and control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Since the application will be performed by the researcher, patients will be blinded in this study. The statistician will be blinded in the evaluation of the data.

Study Groups

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Massage Ball Group

A massage ball will be applied to the patients' hands and feet for 20 minutes.

Group Type EXPERIMENTAL

Massage Ball

Intervention Type OTHER

The massage ball application will be applied to the patients by the researcher for 20 minutes every day for 3 days.

Control Group

No application will be made to this group by the researcher.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Massage Ball

The massage ball application will be applied to the patients by the researcher for 20 minutes every day for 3 days.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* In the 20th - 40th week of pregnancy,
* Least literate,
* Does not have any diagnosed problems related to fetal health,
* Diagnosed with preeclampsia,
* Will be hospitalized for at least 3 days,
* Not having any physical or mental disability,
* Those who are over 18 years of age,
* Agreeing to participate in the research,
* Women with loss of sensation/sensation,

Exclusion Criteria

* Those with chronic hypertension,
* Diagnosed with eclampsia,
* Those with HELLP findings,
* Hospital stay of less than 3 days,
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Filiz Ünal Toprak

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zehra Bicav

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Filiz Ünal Toprak, PhD

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Şevki Çelen, PhD

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik Şehir Hastanesi

Locations

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Ankara Etlik City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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SBU-EBE-ZB-01

Identifier Type: -

Identifier Source: org_study_id

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