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CompletedNCT06066411Updated Jul 23, 2024

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

An interventional study of Massage Ball in Preeclampsia, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Preeclampsia

Keywords

  • Preeclampsia
  • Midwifery
  • Arterial Blood Pressure
  • Anxiety
  • Fatigue
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 66 is below the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Those with chronic hypertension,
  • Diagnosed with eclampsia,
  • Those with HELLP findings,
  • Hospital stay of less than 3 days,
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Massage Ball Group

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

    Other: Massage Ball

  • No intervention
    Control Group

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

Interventions

  • OtherMassage Ball

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

06

What researchers measure

Primary outcomes

  1. Arterial Blood Pressure Monitoring Form I-II

    They are two separate forms created to evaluate the arterial blood pressure of the pregnant women in the experimental and control groups. Form I was created to evaluate the arterial blood pressure of the pregnant women in the experimental group, and Form II was created to evaluate the arterial blood pressure of the pregnant women in the control group. Form I was created to evaluate the arterial blood pressure of the pregnant women in the control group. In Form I, just before the massage ball application, massage The arterial blood pressure of the pregnant woman was measured for 3 days, 30 minutes, 60 minutes and 90 minutes after the application of the ball. In Form II, unlike Form I, arterial blood pressure measurements are made at the first encounter with the pregnant woman, 30 minutes, 60 minutes and 90 minutes later, without any intervention.

    Time frame: Three Days

Secondary outcomes

  1. State-Trait Anxiety Inventory(STAI)

    Each item in the State Anxiety Inventory consists of a four-point Likert scale: Not at all (1), Somewhat (2), Fairly (3), Completely (4), which determines the intensity of the emotions felt by individuals at that moment. Each item consists of four options, depending on the frequency of emotions: Almost never (1), Sometimes (2), Often (3), Almost always (4). There are 20 items in each subscale, and 40 items in total. When calculating the State Anxiety Inventory, scoring is done in reverse for items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The total score obtained from both scales in the inventory varies between 20-80. High scores from the scales indicate high anxiety, while low scores indicate low anxiety levels.

    Time frame: Three Days

  2. Visual Similarity Scale for Fatigue

    It has 2 sub-dimensions: Fatigue and Energy. The 1st, 2nd, 3rd, 4th, 5th, 11th, 12th, 13th, 14th, 15th, 16th, 17th, 18th items of the scale are fatigue and the 6th, 7th, 8th items are fatigue. , 9th and 10th items belong to the energy sub-dimension. It consists of lines with the most positive expression at one end and the most negative expression at the other end, with 10 cm lines between the two expressions. Individuals are asked to mark the part that is suitable for them on a 10 cm line. Then, the value is determined by measuring the marked part with a ruler. While the fatigue subscale items go from the most positive to the most negative, the energy subscale items go from the most negative to the most positive. A high score from the fatigue sub-dimension and a low score from the energy sub-dimension indicates that the severity of fatigue is high.

    Time frame: Three Days

07

Study locations

1 site
  • Ankara Etlik City Hospital
    Ankara, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06066411
Lead sponsor
Saglik Bilimleri Universitesi
Responsible party
Filiz Ünal Toprak (Associate Professor, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Oct 4, 2023
Start date
Oct 2, 2023
Primary completion
Jul 2, 2024
Completion
Jul 19, 2024
Last update
Jul 23, 2024

Study contacts

Zehra Bicav
principal investigator · Saglik Bilimleri Universitesi
Filiz Ünal Toprak, PhD
principal investigator · Saglik Bilimleri Universitesi
Şevki Çelen, PhD
principal investigator · Ankara Etlik Şehir Hastanesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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