EMDR: The Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient.

• Sponsor: Miao-Yi Chen (Other)
• Overall Status: Completed
• CT.gov ID: NCT05836181
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Actual Duration (Months): 34.9
• Patients Per Site Per Month: 3.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Movement Desensitization and Reprocessing Intervention; Blood Pressure; Heart Rate Variability; Anxiety	Behavioral: Eye Movement Desensitization and Reprocessing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• 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
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Dec 10, 2016
• Actual Study Completion Date: Dec 28, 2016

Arms and Interventions

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.	Behavioral: Eye Movement Desensitization and Reprocessing; 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.

Outcome Measures

Primary Outcome Measures

1. Anxiety [Six month]

   HADS-A score

2. depression symptoms [Six month]

   CESD Scale

Secondary Outcome Measures

1. Blood pressure [Six month]

   Blood pressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. age of 20-80 years,

2. diagnosed with primary hypertension as in SBP ≥130 mmHg or DBP ≥80 mmHg,

3. and able to read and understand Chinese or Taiwanese and willing to participate in this study,

Exclusion Criteria:

1. . Secondary hypertension

2. . Hypertension Crisis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chen, miao-yi	Taipei	Neihu	Taiwan	114

Sponsors and Collaborators

• Miao-Yi Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Miao-Yi Chen, National Defense Medical Center Student, National Defense Medical Center, Taiwan
• ClinicalTrials.gov Identifier: NCT05836181
• Other Study ID Numbers: TSGHNDMC
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of May 1, 2023