NCT05542654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

3 days

First QC Date

September 6, 2022

Last Update Submit

September 13, 2022

Conditions

Keywords

Gestational hypertensionpreeclampsiafoot massageblood pressureanxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    Three days

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women aged 18 years and over and diagnosed with hypertension during or before pregnancy were included in the study.

You may not qualify if:

  • Pregnant women who could not communicate in Turkish were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırkoy Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 17950182BACKGROUND
  • 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.

    PMID: 33618054BACKGROUND

MeSH Terms

Conditions

Pre-EclampsiaHypertension, Pregnancy-InducedAnxiety Disorders

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 15, 2022

Study Start

November 5, 2020

Primary Completion

November 8, 2020

Study Completion

February 15, 2022

Last Updated

September 15, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations