AnxietyNCT06215066
Effect of Virtual Reality and Progressive Muscle Relaxation on Anxiety and Attention Among Cardiac Care Unit Patients
A study testing Virtual reality and Modified Progressive Muscle Relaxation in people with Anxiety, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual reality and Modified Progressive Muscle Relaxation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2025to 24 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with a history of neurological impairments such as motor, visual, and auditory disabilities and psychological disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cardiac care unit of Smouha Hospital, which is affiliated to Alexandria University, Egypt.
Alexandria
About this study
Official title: 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:
Read more
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.
Read the 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:
- Sociodemographic and Clinical Assessment.
- Physiological Parameter Assessment.
- Hamilton Anxiety Rating Scale (HAM-A).
- Attention/Distraction Scale.
- Conditions
- Anxiety
- Being tested
- Virtual reality, Modified Progressive Muscle Relaxation
- Keywords
- Anxiety, Attention, Distraction Techniques, MPMR, VR.
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Also called VR
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 RelaxationOther
Also called MPMR
The exercises applied to specific body parts while patients closed their eyes and practiced deep breathing, accompanied by background music.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Modified Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Compares the degree of change between baseline anxiety level (Hamilton Anxiety Rating Scale, HAM-A) and post-intervention scores for both groups.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start20 Apr 2025
- Primary completion20 May 2025
- Study completion24 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Middle East University
- Responsible party
- Sponsor
- Investigators
- Sajeda A Shdaifat, PhD-Cand, Principal investigator, Alexandria UniversityAzza H El-Soussi, Professor, Study director, Alexandria UniversityMohamed I Sanhoury, Asst. Prof, Study director, Alexandria UniversityEman A Ali, Asst. Prof, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215066
- Sponsor's protocol ID
- Distraction Techniques
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality and Modified Progressive Muscle Relaxation Distraction Techniques on Anxiety and Attention Among Cardiac Care Unit Patients; RCT.
- ClinicalTrials.gov ID
- NCT06215066
- Acronym / sponsor ID
- Distraction Techniques
- Conditions
- Anxiety
- Keywords
- Anxiety, Attention, Distraction Techniques, MPMR, VR.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Middle East University
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 24 May 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sociodemographic and Clinical Assessment.
- Physiological Parameter Assessment.
- Hamilton Anxiety Rating Scale (HAM-A).
- Attention/Distraction Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group (VR) | Active comparator | Device: Virtual realityThe 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. |
| Modified Progressive Muscle Relaxation Group (MPMR) | Active comparator | Other: Modified Progressive Muscle RelaxationThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with a history of neurological impairments such as motor, visual, and auditory disabilities and psychological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityAlso: VRThe 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 Group (VR) |
| Modified Progressive Muscle RelaxationAlso: MPMRThe exercises applied to specific body parts while patients closed their eyes and practiced deep breathing, accompanied by background music. | Other | Modified Progressive Muscle Relaxation Group (MPMR) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sajeda A Shdaifat, PhD-Cand principal investigator
Alexandria University
Azza H El-Soussi, Professor study director
Alexandria University
Mohamed I Sanhoury, Asst. Prof study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Modified Progressive Muscle Relaxation in people with Anxiety, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.