Pre-EclampsiaNCT05542654
The Effect of Foot Massage on Blood Pressure and Anxiety Levels in Pregnants With Hypertension
A study testing Foot Massage in people with Pre-Eclampsia and Gestational Hypertension, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia, Gestational Hypertension, Chronic Hypertension With Pre-Eclampsia
- What is being tested?
- Foot Massage
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2020to 15 Feb 2022
- 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
- Pregnant women aged 18 years and over and diagnosed with hypertension during or before pregnancy were included in the study.
Who cannot join
- Pregnant women who could not communicate in Turkish were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırkoy Training and Research Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Pre-Eclampsia, Gestational Hypertension, Chronic Hypertension With Pre-Eclampsia, Superimposed Pre-Eclampsia
- Being tested
- Foot Massage
- Keywords
- Gestational hypertension, preeclampsia, foot massage, blood pressure, anxiety
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot MassageOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted15 Sep 2022
- Study start5 Nov 2020
- Primary completion8 Nov 2020
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- 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
- Single group
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilayda sel, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542654
- Sponsor's protocol ID
- Bakirkoystatehospital
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17950182Corrigan 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.
PubMed 33618054
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Massage Applied to Hypertensive Pregnant Women Bakirkoy Doctor Sadi Konuk Training and Research Hospital
- ClinicalTrials.gov ID
- NCT05542654
- Acronym / sponsor ID
- Bakirkoystatehospital
- Conditions
- Pre-Eclampsia, Gestational Hypertension, Chronic Hypertension With Pre-Eclampsia, Superimposed Pre-Eclampsia
- Keywords
- Gestational hypertension, preeclampsia, foot massage, blood pressure, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 8 Nov 2020 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 15 Sep 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Model description
- randomized controlled trial
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women aged 18 years and over and diagnosed with hypertension during or before pregnancy were included in the study.
Key exclusion criteria (1 listed)
- Pregnant women who could not communicate in Turkish were excluded from the study.
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 |
|---|---|---|
| Foot MassagePregnant 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. | Other | – |
Primary outcome
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.
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 15 Sep 2022.
- Background: PubMed 17950182Ejindu 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.
- Background: PubMed 33618054Corrigan 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Massage in people with Pre-Eclampsia and Gestational Hypertension, run by Bandırma Onyedi Eylül University 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 1 inclusion and 1 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 15 Sep 2022. 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?
Blood Pressure (time frame: Three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05542654, which also lists 2 linked publications.
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 15 Sep 2022.