Clinical trial NCT06066411: The Effect of Massage Ball Application on Blood Pressure, Fatigue and Anxiety in Pregnant With Preeclampsia
Official title: The Effect of Massage Ball Application on Arterial Blood Pressure, Fatigue and Anxiety in Pregnant Women Diagnosed With Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Keywords: Preeclampsia
Midwifery
Arterial Blood Pressure
Anxiety
Fatigue
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with a massage ball group and control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Arterial Blood Pressure Monitoring Form I-II
timeFrame: Three Days
Secondary outcomes:
measure: State-Trait Anxiety Inventory(STAI)
timeFrame: Three Days
measure: Visual Similarity Scale for Fatigue
timeFrame: Three Days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Zehra Bicav
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Filiz Ünal Toprak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Etlik Şehir Hastanesi
name: Şevki Çelen, PhD
role: PRINCIPAL_INVESTIGATOR
References: