- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05836181
The Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient. (EMDR)
April 18, 2023 updated by: Miao-Yi Chen
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
Eye Movement Desensitization and Reprocessing intervention may improve anxiety, depression, systolic blood pressure and heart rate variability in patients with hypertension.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Neihu
-
Taipei, Neihu, Taiwan, 114
- Chen, miao-yi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eye Movement Desensitization and Reprocessing intervention
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.
|
Effects of Eye Movement Desensitization and Reprocessing on Anxiety, Depression, Quality of Life, Blood Pressure and Heart Rate Variability in Patients with Hypertension.
|
No Intervention: Eye Movement Desensitization and Reprocessing control
The control group received routine care and treatment as usual.
They did not receive EMDR intervention or counseling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Six month
|
HADS-A score
|
Six month
|
depression symptoms
Time Frame: Six month
|
CESD Scale
|
Six month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Six month
|
Blood pressure
|
Six month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2014
Primary Completion (Actual)
December 10, 2016
Study Completion (Actual)
December 28, 2016
Study Registration Dates
First Submitted
April 18, 2023
First Submitted That Met QC Criteria
April 18, 2023
First Posted (Actual)
May 1, 2023
Study Record Updates
Last Update Posted (Actual)
May 1, 2023
Last Update Submitted That Met QC Criteria
April 18, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TSGHNDMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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