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

NCT ID: NCT06215066

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-20
• Study Completion Date: 2025-05-24

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.

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Virtual reality

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Modified Progressive Muscle Relaxation

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Modified Progressive Muscle Relaxation

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

Intervention Type: OTHER

Other Intervention Names

VR; MPMR

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Middle East University

OTHER

Sponsor Role: collaborator

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sajeda A Shdaifat, PhD-Cand

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Azza H El-Soussi, Professor

Role: STUDY_DIRECTOR

Alexandria University

Mohamed I Sanhoury, Asst. Prof

Role: STUDY_DIRECTOR

Alexandria University

Eman A Ali, Asst. Prof

Role: STUDY_DIRECTOR

Alexandria University

Locations

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

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

Distraction Techniques

Identifier Type: -

Identifier Source: org_study_id