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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05542654
Other study ID # Bakirkoystatehospital
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2020
Est. completion date February 15, 2022

Study information

Verified date September 2022
Source Bandirma Onyedi Eylül University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 15, 2022
Est. primary completion date November 8, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Foot Massage
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.

Locations

Country Name City State
Turkey Bakirkoy Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. Epub 2007 May 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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