Effect of Virtual Reality and Progressive Muscle Relaxation on Anxiety and Attention Among Cardiac Care Unit Patients

Not Applicable

Not yet recruiting

• Conditions: Anxiety
• Interventions: Other: Modified Progressive Muscle Relaxation Exercise; Device: The virtual reality box

• Registration Number: NCT06215066
• Lead Sponsor: Alexandria University

Brief Summary

This study aims to:

Assess the effect of virtual reality and modified progressive muscle relaxation distraction techniques on anxiety, attention and getting distracted from the external environment among cardiac care unit patients.

Research hypotheses:

H1: Patients who receive VR intervention have lower Hamilton Anxiety Rating (HAM-A) scores than those who receive modified PMR intervention.

H2: Patients who receive VR intervention exhibit improvement in their physiological parameters than those who receive modified PMR intervention.

H3: Patients who receive VR intervention have lower Attention/Distraction scores than those who receive modified PMR intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Study Start: 2025-04-30
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Admitted to CCU for at least 3 days after stability, so they would have experienced CCU routines in all shifts.
• Diagnosed with cardiac disease.
• Aged from 18 to 60 years, from both genders.
• Patients who are conscious and stable condition.
• Patients without a history of neurological impairment such as motor, visual and auditory disabilities and psychological disorders.

Exclusion Criteria

• Patients staying in the CCU for less than 3 days.
• Who is unconscious or unstable condition.
• Sedated or refuse to participate.
• Have psychiatric diseases and receive psychological drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Progressive Muscle Relaxation Group (MPMR)	Modified Progressive Muscle Relaxation Exercise	-
Virtual Reality Group (VR)	The virtual reality box	-

Primary Outcome Measures

Name	Time	Method
Comparing the outcomes of the physiological parameter (respiratory rate) for both groups.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.	Measures the physiological parameter including respiratory rate by breaths/minutes and rhythm regular or irregular.
Comparing the outcomes of the physiological parameter (oxygen saturation level) for both groups.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.	Measures the physiological parameter including oxygen saturation level by percent (%).
Comparing the outcomes of the physiological parameter (temperature) for both groups.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.	Measures the physiological parameter including temperature by Celsius.
Comparing the outcomes of the physiological parameter (heart rate) for both groups.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.	Measures the physiological parameter including heart rate by beats/minutes and rhythm regular or irregular.
Comparing the outcomes of the physiological parameter (pain level) for both groups.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.	Measures the physiological parameter including pain level by Numerical Rating Scale (NRS) from 0 to 10.
Comparing the outcomes of the physiological parameter (blood pressure) for both groups.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.	Measures the physiological parameter including blood pressure by millimeters of mercury (mmHg).
Comparing the outcomes of the anxiety level for both groups.	The anxiety level baseline (pre intervention) will be assessed individually for each patient.	Measures the anxiety level by using the Hamilton Anxiety Rating Scale (HAM-A), the total score of each item ranges from 0 to 56. A score where \<17 indicates mild severity, from 18 to 24 is mild to moderate severity, and from 25 to 30 is moderate to severe.

Secondary Outcome Measures

Name	Time	Method
Comparing the outcomes of the physiological parameter (respiratory rate) for both groups.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.	Measures the physiological parameter before and after the intervention including respiratory rate by breaths/minutes and rhythm regular or irregular.
Comparing the outcomes of the physiological parameter (temperature) for both groups.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.	Measures the physiological parameter before and after the intervention including temperature by Celsius.
Comparing the outcomes of the physiological parameter (heart rate) for both groups.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.	Measures the physiological parameter before and after the intervention including heart rate by beats/minutes and rhythm regular or irregular.
Comparing the outcomes of the physiological parameter (pain level) for both groups.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.	Measures the physiological parameter before and after the intervention including pain level by Numerical Rating Scale (NRS) from 0 to 10.
Comparing the outcomes of the anxiety level for both groups.	10 minutes before the intervention and 10 minutes after the intervention for one time, at the morning, evening and night shift for three consecutive days.	Measures the anxiety level before the intervention by using the Hamilton Anxiety Rating Scale (HAM-A), the total score of each item ranges from 0 to 56. A score where \<17 indicates mild severity, from 18 to 24 is mild to moderate severity, and from 25 to 30 is moderate to severe.; Measures the anxiety level after the intervention by using the Hamilton Anxiety Rating Scale (HAM-A), the total score of each item ranges from 0 to 56. A score where \<17 indicates mild severity, from 18 to 24 is mild to moderate severity, and from 25 to 30 is moderate to severe.
Comparing the outcomes of the physiological parameter (oxygen saturation level) for both groups.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.	Measures the physiological parameter before and after the intervention including oxygen saturation level by percent (%).
Comparing the outcomes of the physiological parameter (blood pressure) for both groups.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.	Measures the physiological parameter before and after the intervention including blood pressure by millimeters of mercury (mmHg).