- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542654
The Effect of Foot Massage on Blood Pressure and Anxiety Levels in Pregnants With Hypertension
September 13, 2022 updated by: ilayda sel, Bandırma Onyedi Eylül University
Foot Massage Applied to Hypertensive Pregnant Women Bakirkoy Doctor Sadi Konuk Training and Research Hospital
This research was conducted as a prospective, experimental and randomised controlled research to determine the effect of foot massage applied to pregnant women with hypertension on blood pressure and anxiety levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The sample of the research a total of 80 pregnants, 40 interventions and 40 in the control groups, which were randomly selected from hypertension pregnant women who applied to Health Sciences University Istanbul Bakırköy Doctor Sadi Konuk Training and Research Hospital (BEAH).
After the participants were given written and verbal information about the research, the intervention group received a foot massage for three days, 15 minutes on each foot, for a total of 30 minutes, while the control group did not receive foot massage.
In the research; Participant Promotion Form which contains questions about general health appearances and socio-demographic, gynecological and obstetric story, Vital Finding Monitoring Form to save blood pressure, pulse and breathing numbers restrained before and after foot massage, State and Trade Anxiety Inventory (STAI) which evaluates the level of anxiety, was used.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Bakırkoy Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant women aged 18 years and over and diagnosed with hypertension during or before pregnancy were included in the study.
Exclusion Criteria:
- Pregnant women who could not communicate in Turkish were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure
Time Frame: Three days
|
Hypertensive disorder is a systolic blood pressure of 140 mmHg and a diastolic blood pressure of 90 mmHg and above that occurs after the 20th week of pregnancy.
In this respect, blood pressure measurement is extremely important in pregnant women.
In this study, a total of 30 minutes of foot massage, 15 minutes on each foot, was applied to pregnant women with hypertension in the intervention group for three days, and blood pressure was measured at regular intervals.
(Before the massage, 5 minutes after the massage, 15 minutes after the massage, 30 minutes after the massage, 90 minutes after the massage, 120 minutes after the massage) No intervention was applied to pregnant women with hypertension in the control group.
|
Three days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ejindu A. The effects of foot and facial massage on sleep induction, blood pressure, pulse and respiratory rate: crossover pilot study. Complement Ther Clin Pract. 2007 Nov;13(4):266-75. doi: 10.1016/j.ctcp.2007.03.008. Epub 2007 May 8.
- Corrigan L, O'Farrell A, Moran P, Daly D. Hypertension in pregnancy: Prevalence, risk factors and outcomes for women birthing in Ireland. Pregnancy Hypertens. 2021 Jun;24:1-6. doi: 10.1016/j.preghy.2021.02.005. Epub 2021 Feb 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 5, 2020
Primary Completion (Actual)
November 8, 2020
Study Completion (Actual)
February 15, 2022
Study Registration Dates
First Submitted
September 6, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Actual)
September 15, 2022
Last Update Submitted That Met QC Criteria
September 13, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bakirkoystatehospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.