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

Effect of Virtual Reality and Modified Progressive Muscle Relaxation Distraction Techniques on Anxiety and Attention Among Cardiac Care Unit Patients; RCT.

A randomized controlled trial with two parallel groups was conducted, to determine the effect of virtual reality (VR) and modified progressive muscle relaxation (MPMR) distraction techniques on anxiety, attention and getting distracted from the external environment among cardiac care unit patients.

The study is based on the following hypotheses:

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

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

H3: Patients who receive VR intervention have higher Attention/Distraction scores than those who receive MPMR intervention.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Device: Virtual reality; Other: Modified Progressive Muscle Relaxation

Detailed Description

This randomized controlled trial with two parallel groups was conducted in the cardiac care unit of Smouha Hospital, affiliated with Alexandria University, Egypt.

A total of 158 patients were recruited using a simple random sampling method and assigned to one of two groups to determine the effects of virtual reality (VR) and modified progressive muscle relaxation (MPMR) distraction techniques on anxiety, attention, and distraction from the external environment among cardiac care unit patients.

Four assessment tools were used:

1. Sociodemographic and Clinical Assessment.
2. Physiological Parameter Assessment.
3. Hamilton Anxiety Rating Scale (HAM-A).
4. Attention/Distraction Scale.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Cardiac care unit of Smouha Hospital, which is affiliated to Alexandria University, Egypt.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Admitted to CCU for at least 3 days after stability.
• Patients who are conscious and stable condition and all of whom exhibited varying levels of anxiety.

Exclusion Criteria:

- Patients with a history of neurological impairments such as motor, visual, and auditory disabilities and psychological disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Virtual Reality Group (VR); The intervention was administered three times per day, 10 minutes each session, for three consecutive days. The VR goggles and headset phone were placed on the patient's head, straps secured, and lens spacing adjusted for a clear visual field. Patients were instructed to use head movements to control the cursor and interact with the virtual content. The 3D video clips with natural sceneries and background music were played to create a relaxing experience.	Device: Virtual reality; The VR goggles and headset phone were placed on the patient's head, straps secured, and lens spacing adjusted for a clear visual field. Patients were instructed to use head movements to control the cursor and interact with the virtual content. The 3D video clips with natural sceneries and background music were played to create a relaxing experience.; Other Names: VR
Active Comparator: Modified Progressive Muscle Relaxation Group (MPMR); The intervention was administered three times per day, 10 minutes each session, for three consecutive days. The exercises applied to specific body parts while patients closed their eyes and practiced deep breathing, accompanied by background music.	Other: Modified Progressive Muscle Relaxation; The exercises applied to specific body parts while patients closed their eyes and practiced deep breathing, accompanied by background music.; Other Names: MPMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of changes in physiological parameters between baseline and post-intervention scores for both groups.	Compares the degree of change between baseline physiological parameters (heart rate and rhythm, respiratory rate and rhythm, oxygen saturation, blood pressure, and pain level) and post-intervention scores for both groups.	Baseline physiological parameter assessments were conducted individually for each patient on the first day of the intervention. Post-intervention assessments were conducted during the same three shifts across the three-day period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of changes in anxiety levels between baseline and post-intervention scores for both groups.	Compares the degree of change between baseline anxiety level (Hamilton Anxiety Rating Scale, HAM-A) and post-intervention scores for both groups.	Baseline anxiety level assessments were conducted individually for each patient on the first day of the intervention. Post-intervention assessments were conducted during the same three shifts across the three-day period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of attention / distraction levels between both groups at the end of the intervention.	Compares attention / distraction levels using the Attention / Distraction Scale for both groups.	Attention / distraction levels were assessed individually for each patient during the night shift on the third day after completing all nine intervention sessions.

Collaborators and Investigators

• Sponsor: Alexandria University
• Collaborators: Middle East University
• Investigators: Principal Investigator: Sajeda A Shdaifat, PhD-Cand, Alexandria University; Study Director: Azza H El-Soussi, Professor, Alexandria University; Study Director: Mohamed I Sanhoury, Asst. Prof, Alexandria University; Study Director: Eman A Ali, Asst. Prof, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2025
• Primary Completion (Actual): May 20, 2025
• Study Completion (Actual): May 24, 2025

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety, Attention, Distraction Techniques, MPMR, VR.
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Distraction Techniques

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
• product manufactured in and exported from the U.S.: No