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

NCT06215066 | Completed

• 1 other identifier: Distraction Techniques
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Keywords

Anxiety, Attention, Distraction Techniques, MPMR, VR.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of changes in anxiety levels between baseline 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 Outcomes (1)

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

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

Study Arms (2)

Virtual Reality Group (VR)

ACTIVE COMPARATOR

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

Modified Progressive Muscle Relaxation Group (MPMR)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: VR

Virtual Reality Group (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.

Also known as: MPMR

Modified Progressive Muscle Relaxation Group (MPMR)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead
• Middle East University: collaborator

Study Sites (1)

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

Alexandria, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sajeda A Shdaifat, PhD-Cand

  Alexandria University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding was limited to the statistician (outcome assessor). Participants, care providers, and investigators were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total sample of 158 patients was required. A computer randomizer (www.randomizer.org ) was used to assign numbers to patients who were included. A 1:1 randomized allocation was applied to assign patients to each group. As an active comparator, Group A received the virtual reality (VR) intervention (83 patients), whereas Group B received the modified progressive muscle relaxation (MPMR) intervention (75 patients). Blinding in this study was limited to the statistician.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: January 22, 2024
• Study Start: April 20, 2025
• Primary Completion: May 20, 2025
• Study Completion: May 24, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)