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

NCT06066411 | Completed

• 1 other identifier: SBU-EBE-ZB-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Keywords

Preeclampsia; Midwifery; Arterial Blood Pressure; Anxiety; Fatigue

Outcome Measures

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.

  Three Days

Secondary Outcomes (2)

• State-Trait Anxiety Inventory(STAI)

  Three Days

• Visual Similarity Scale for Fatigue

  Three Days

Study Arms (2)

Massage Ball Group

EXPERIMENTAL

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

Other: Massage Ball

Control Group

NO INTERVENTION

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

Interventions

Massage Ball OTHER

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

Massage Ball Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since it is a study conducted on pregnant women, it concerns the female gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pre-Eclampsia; Anxiety Disorders; Fatigue

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zehra Bicav

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Filiz Ünal Toprak, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Şevki Çelen, PhD

  Ankara Etlik Şehir Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two groups with a massage ball group and control group

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: October 2, 2023
• Primary Completion: July 2, 2024
• Study Completion: July 19, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)