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

Primary Purpose

Preeclampsia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage Ball
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preeclampsia focused on measuring Preeclampsia, Midwifery, Arterial Blood Pressure, Anxiety, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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,

Sites / Locations

  • Ankara Etlik City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Massage Ball Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 27, 2023
Last Updated
October 12, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT06066411
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
July 2, 2024 (Anticipated)
Study Completion Date
September 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Preeclampsia, Midwifery, Arterial Blood Pressure, Anxiety, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups with a massage ball group and control group
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Massage Ball Group
Arm Type
Experimental
Arm Description
A massage ball will be applied to the patients' hands and feet for 20 minutes.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No application will be made to this group by the researcher.
Intervention Type
Other
Intervention Name(s)
Massage Ball
Intervention Description
The massage ball application will be applied to the patients by the researcher for 20 minutes every day for 3 days.
Primary Outcome Measure Information:
Title
Arterial Blood Pressure Monitoring Form I-II
Description
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 Outcome Measure Information:
Title
State-Trait Anxiety Inventory(STAI)
Description
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
Title
Visual Similarity Scale for Fatigue
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Since it is a study conducted on pregnant women, it concerns the female gender.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zehra Bicav
Phone
05439307234
Email
zehrabcv77@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Bicav
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filiz Ünal Toprak, PhD
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Şevki Çelen, PhD
Organizational Affiliation
Ankara Etlik Şehir Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Etlik City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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