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Completed

NCT Number: NCT06215066

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

About this study

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:

  • Sociodemographic and Clinical Assessment.
  • Physiological Parameter Assessment.
  • Hamilton Anxiety Rating Scale (HAM-A).
  • Attention/Distraction Scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality

Device

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

Modified Progressive Muscle Relaxation

Other

The exercises applied to specific body parts while patients closed their eyes and practiced deep breathing, accompanied by background music.

Other names: MPMR

Primary outcomes

  1. Comparison of changes in physiological parameters between baseline and post-intervention scores for both groups.

    Time frame: 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.

    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.

Secondary outcomes

  1. Comparison of changes in anxiety levels between baseline and post-intervention scores for both groups.

    Time frame: 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.

    Compares the degree of change between baseline anxiety level (Hamilton Anxiety Rating Scale, HAM-A) and post-intervention scores for both groups.

Other outcomes

  1. Comparison of attention / distraction levels between both groups at the end of the intervention.

    Time frame: Attention / distraction levels were assessed individually for each patient during the night shift on the third day after completing all nine intervention sessions.

    Compares attention / distraction levels using the Attention / Distraction Scale for both groups.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Collaborators

  • Middle East University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2024
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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