Reflexology, Hypertension, Acupressure, Traditional Medicine Clinical Trial
Official title:
Effect of Foot Reflexology on Blood Pressure and Pulse Rate: A Randomized Clinical Trial in Stage-2 Hypertensive Patients
| Verified date | August 2020 |
| Source | Khon Kaen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere with them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Foot Reflexology is one of a complementary therapies that has been proved for its ability to decrease blood pressure (BP), however, there is limited data in patients with stage-2 HT. We aimed to examine the effectiveness of foot reflexology as adjunctive therapy for BP lowering. This was a single-center randomized clinical trial. Hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). Foot reflexology was performed in the intervention group during a clinical visit. Office BP and pulse rate (PR) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.
| Status | Completed |
| Enrollment | 94 |
| Est. completion date | October 31, 2016 |
| Est. primary completion date | May 31, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Diagnosed stage-2 HT (defined by office SBP=140 mmHg and/or DBP =90 mmHg at first hospital visit) - On stable anti-HT drugs for at least 3 months before enrollment. Exclusion Criteria: - Pregnant women - History of foot surgery or bone fracture - Skin disease of the foot - Diabetes neuropathy |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Khon Kaen University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of blood pressure level | The office blood pressures (BP) were measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office BPs were measured at baseline and after resting in a quiet room for 15 and 30 min. A validated, FDA-approved automatic BP device (DINAMAP Pro 300, GE healthcare) with the appropriate cuff size for individual arm circumference was used for measurement. Two BP measurements were taken at 2-min intervals, and the average BP were recorded for analyses. | Change from Baseline Systolic Blood Pressure at 15 minutes | |
| Primary | Change of blood pressure level | The office blood pressures (BP) were measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office BPs were measured at baseline and after resting in a quiet room for 15 and 30 min. A validated, FDA-approved automatic BP device (DINAMAP Pro 300, GE healthcare) with the appropriate cuff size for individual arm circumference was used for measurement. Two BP measurements were taken at 2-min intervals, and the average BP were recorded for analyses. | Change from Baseline Systolic Blood Pressure at 30 minutes | |
| Primary | Change of pulse rate | The office pulse rate (PR) was measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office PR was measured at baseline and after resting in a quiet room for 15 and 30 min. | Change from baseline pulse rate at 15 minutes | |
| Primary | Change of pulse rate | The office pulse rate (PR) was measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office PR was measured at baseline and after resting in a quiet room for 15 and 30 min. | Change from baseline pulse rate at 30 minutes | |
| Secondary | Difference in degree of reduction of blood pressure between groups | Compare the degree of reduction of blood pressure between intervention and control group | Difference in degree of reduction of blood pressure from baseline after 30 min | |
| Secondary | Difference in degree of reduction of pulse rate between groups | Compare the degree of reduction of pulse rate between intervention and control group | Difference in degree of reduction of pulse rate from baseline after 30 min |