The Effect of Foot Massage on Blood Pressure and Anxiety Levels in Pregnants With Hypertension
Primary Purpose
Pre-Eclampsia, Gestational Hypertension, Chronic Hypertension With Pre-Eclampsia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Foot Massage
Sponsored by
About this trial
This is an interventional supportive care trial for Pre-Eclampsia focused on measuring Gestational hypertension, preeclampsia, foot massage, blood pressure, anxiety
Eligibility Criteria
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.
Sites / Locations
- Bakırkoy Training and Research Hospital
Outcomes
Primary Outcome Measures
Blood Pressure
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05542654
First Posted
September 6, 2022
Last Updated
September 13, 2022
Sponsor
Bandırma Onyedi Eylül University
1. Study Identification
Unique Protocol Identification Number
NCT05542654
Brief Title
The Effect of Foot Massage on Blood Pressure and Anxiety Levels in Pregnants With Hypertension
Official Title
Foot Massage Applied to Hypertensive Pregnant Women Bakirkoy Doctor Sadi Konuk Training and Research Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
November 8, 2020 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bandırma Onyedi Eylül University
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Gestational Hypertension, Chronic Hypertension With Pre-Eclampsia, Superimposed Pre-Eclampsia
Keywords
Gestational hypertension, preeclampsia, foot massage, blood pressure, anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
randomized controlled trial
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Foot Massage
Intervention Description
Pregnant women in the intervention group were given a foot massage for 15 minutes each, for a total of 30 minutes for three days, while the control group did not receive foot massage.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
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.
Time Frame
Three days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Bakırkoy Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17950182
Citation
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.
Results Reference
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PubMed Identifier
33618054
Citation
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.
Results Reference
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The Effect of Foot Massage on Blood Pressure and Anxiety Levels in Pregnants With Hypertension
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