PreeclampsiaNCT06066411
The Effect of Massage Ball Application on Blood Pressure, Fatigue and Anxiety in Pregnant With Preeclampsia
A study testing Massage Ball in people with Preeclampsia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Massage Ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 19 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Those who are over 18 years of age,
- Agreeing to participate in the research,
- Women with loss of sensation/sensation,
Who cannot join
- Those with chronic hypertension,
- Diagnosed with eclampsia,
- Those with HELLP findings,
- Hospital stay of less than 3 days,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Massage Ball Application on Arterial Blood Pressure, Fatigue and Anxiety in Pregnant Women Diagnosed With Preeclampsia
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.
- Conditions
- Preeclampsia
- Being tested
- Massage Ball
- Keywords
- Preeclampsia, Midwifery, Arterial Blood Pressure, Anxiety, Fatigue
- Medical subject headings
- Pre-Eclampsia, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage BallOther
The massage ball application will be applied to the patients by the researcher for 20 minutes every day for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Massage Ball Group | Experimental | A massage ball will be applied to the patients' hands and feet for 20 minutes. Receives: Other: Massage Ball |
| Control Group | No intervention | No application will be made to this group by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three Days
Secondary outcomes (2)
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.
Measured: Three Days
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.
Measured: Three Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start2 Oct 2023
- Primary completion2 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with a massage ball group and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Ünal Toprak, Saglik Bilimleri Universitesi
- Investigators
- Zehra Bicav, Principal investigator, Saglik Bilimleri UniversitesiFiliz Ünal Toprak, PhD, Principal investigator, Saglik Bilimleri UniversitesiŞevki Çelen, PhD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066411
- Sponsor's protocol ID
- SBU-EBE-ZB-01
- Status last verified
- Jul 2024
- First submitted
- 27 Sep 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage Ball Application on Arterial Blood Pressure, Fatigue and Anxiety in Pregnant Women Diagnosed With Preeclampsia
- ClinicalTrials.gov ID
- NCT06066411
- Acronym / sponsor ID
- SBU-EBE-ZB-01
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Midwifery, Arterial Blood Pressure, Anxiety, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with a massage ball group and control group
| Arm | Type | Receives |
|---|---|---|
| Massage Ball Group | Experimental | Other: Massage BallA massage ball will be applied to the patients' hands and feet for 20 minutes. |
| Control Group | No intervention | –No application will be made to this group by the researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (4 listed)
- Those with chronic hypertension,
- Diagnosed with eclampsia,
- Those with HELLP findings,
- Hospital stay of less than 3 days,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage BallThe massage ball application will be applied to the patients by the researcher for 20 minutes every day for 3 days. | Other | Massage Ball Group |
Primary outcome
Arterial Blood Pressure Monitoring Form I-II
Time frame: Three Days
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.
2 secondary outcomes
State-Trait Anxiety Inventory(STAI)
Time frame: Three Days
Visual Similarity Scale for Fatigue
Time frame: Three Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zehra Bicav principal investigator
Saglik Bilimleri Universitesi
Filiz Ünal Toprak, PhD principal investigator
Saglik Bilimleri Universitesi
Şevki Çelen, PhD principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Ball in people with Preeclampsia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Blood Pressure Monitoring Form I-II (time frame: Three Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.