Back to resultsThe Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient. (EMDR)
Primary Purpose
Eye Movement Desensitization and Reprocessing Intervention, Blood Pressure, Heart Rate Variability
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Eye Movement Desensitization and Reprocessing
Sponsored by
About this trial
This is an interventional health services research trial for Eye Movement Desensitization and Reprocessing Intervention
Eligibility Criteria
Inclusion Criteria: age of 20-80 years, diagnosed with primary hypertension as in SBP ≥130 mmHg or DBP ≥80 mmHg, and able to read and understand Chinese or Taiwanese and willing to participate in this study, Exclusion Criteria: . Secondary hypertension . Hypertension Crisis.
Sites / Locations
- Chen, miao-yi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Eye Movement Desensitization and Reprocessing intervention
Eye Movement Desensitization and Reprocessing control
Arm Description
The goal of EMDR is to help manage physical and mental unpleasant experiences due to hypertension. The intervention group received EMDR therapy included eight phases, each lasting 60-90 minutes, and the intervention consisted of four weekly. In this study, a Nurse practitioner trained in EMDR performs an intervention in an outpatient clinic's quiet, empty room.
The control group received routine care and treatment as usual. They did not receive EMDR intervention or counseling.
Outcomes
Primary Outcome Measures
Anxiety
HADS-A score
depression symptoms
CESD Scale
Secondary Outcome Measures
Blood pressure
Blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05836181
Brief Title
The Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient.
Acronym
EMDR
Official Title
The Effect of Eye Movement Desensitization and Reprocessing Reducing Anxiety, Depressive Symptoms, Blood Pressure, and Heart Rate Variability in Primary Hypertension： A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
December 10, 2016 (Actual)
Study Completion Date
December 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Miao-Yi Chen
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
Eye Movement Desensitization and Reprocessing intervention may improve anxiety, depression, systolic blood pressure and heart rate variability in patients with hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Movement Desensitization and Reprocessing Intervention, Blood Pressure, Heart Rate Variability, Anxiety
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eye Movement Desensitization and Reprocessing intervention
Arm Type
Experimental
Arm Description
The goal of EMDR is to help manage physical and mental unpleasant experiences due to hypertension. The intervention group received EMDR therapy included eight phases, each lasting 60-90 minutes, and the intervention consisted of four weekly. In this study, a Nurse practitioner trained in EMDR performs an intervention in an outpatient clinic's quiet, empty room.
Arm Title
Eye Movement Desensitization and Reprocessing control
Arm Type
No Intervention
Arm Description
The control group received routine care and treatment as usual. They did not receive EMDR intervention or counseling.
Intervention Type
Behavioral
Intervention Name(s)
Eye Movement Desensitization and Reprocessing
Intervention Description
Effects of Eye Movement Desensitization and Reprocessing on Anxiety, Depression, Quality of Life, Blood Pressure and Heart Rate Variability in Patients with Hypertension.
Primary Outcome Measure Information:
Title
Anxiety
Description
HADS-A score
Time Frame
Six month
Title
depression symptoms
Description
CESD Scale
Time Frame
Six month
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure
Time Frame
Six month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age of 20-80 years,
diagnosed with primary hypertension as in SBP ≥130 mmHg or DBP ≥80 mmHg,
and able to read and understand Chinese or Taiwanese and willing to participate in this study,
Exclusion Criteria:
. Secondary hypertension
. Hypertension Crisis.
Facility Information:
Facility Name
Chen, miao-yi
City
Taipei
State/Province
Neihu
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient.
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