Clinical trial NCT06215066: Effect of Virtual Reality and Progressive Muscle Relaxation on Anxiety and Attention Among Cardiac Care Unit Patients
Official title: Effect of Virtual Reality and Modified Progressive Muscle Relaxation Distraction Techniques on Anxiety and Attention Among Cardiac Care Unit Patients; RCT.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: "Attention" "Distraction" "Progressive Muscle Relaxation" "Virtual Reality"
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients were randomly assigned to one of both groups (PMR group and VR group, 75 patients for each) by computer-generated sequences and a sequential number will be assigned to the patient.
Primary purpose: TREATMENT

Brief summary: This study aims to:

Assess the effect of virtual reality and modified progressive muscle relaxation distraction techniques on anxiety, attention and getting distracted from the external environment among cardiac care unit patients.

Research hypotheses:

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

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

H3: Patients who receive VR intervention have lower Attention/Distraction scores than those who receive modified PMR intervention.


Eligibility criteria: Inclusion Criteria:

* Admitted to CCU for at least 3 days after stability, so they would have experienced CCU routines in all shifts.
* Diagnosed with cardiac disease.
* Aged from 18 to 60 years, from both genders.
* Patients who are conscious and stable condition.
* Patients without a history of neurological impairment such as motor, visual and auditory disabilities and psychological disorders.

Exclusion Criteria:

* Patients staying in the CCU for less than 3 days.
* Who is unconscious or unstable condition.
* Sedated or refuse to participate.
* Have psychiatric diseases and receive psychological drugs.

Primary outcomes:
measure: Comparing the outcomes of the physiological parameter (heart rate and rhythm) for both groups.
timeFrame: The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
measure: Comparing the outcomes of the physiological parameter (respiratory rate and rhythm) for both groups.
timeFrame: The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
measure: Comparing the outcomes of the physiological parameter (oxygen saturation level) for both groups.
timeFrame: The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
measure: Comparing the outcomes of the physiological parameter (pain level) for both groups.
timeFrame: The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
measure: Comparing the outcomes of the physiological parameter (blood pressure) for both groups.
timeFrame: The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
measure: Comparing the outcomes of the anxiety level for both groups.
timeFrame: The anxiety level baseline (pre intervention) will be assessed individually for each patient.
Secondary outcomes:
measure: Comparing the outcomes of the physiological parameter (heart rate and rhythm) for both groups.
timeFrame: 5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
measure: Comparing the outcomes of the physiological parameter (respiratory rate and rhythm) for both groups.
timeFrame: 5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
measure: Comparing the outcomes of the physiological parameter (oxygen saturation level) for both groups.
timeFrame: 5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
measure: Comparing the outcomes of the physiological parameter (blood pressure) for both groups.
timeFrame: 5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
measure: Comparing the outcomes of the physiological parameter (pain level) for both groups.
timeFrame: 5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
measure: Comparing the outcomes of the anxiety level for both groups.
timeFrame: 10 minutes before the intervention and 10 minutes after the intervention for one time, at the morning, evening and night shift for three consecutive days.
Other outcomes:
measure: Compare the degree of changes between baseline physiological parameter (heart rate and rhythm) and post-intervention scores.
timeFrame: immediately after the intervention.
measure: Compare the degree of changes between baseline physiological parameter (respiratory rate and rhythm) and post-intervention scores.
timeFrame: immediately after the intervention.
measure: Compare the degree of changes between baseline physiological parameter (oxygen saturation level) and post-intervention scores.
timeFrame: immediately after the intervention.
measure: Compare the degree of changes between baseline physiological parameter (blood pressure) and post-intervention scores.
timeFrame: immediately after the intervention.
measure: Compare the degree of changes between baseline physiological parameter (pain level) and post-intervention scores.
timeFrame: immediately after the intervention.
measure: Compare the degree of changes between baseline anxiety level and post-intervention scores.
timeFrame: immediately after the intervention.
measure: Look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter (heart rate and rhythm) to the final measurement at the end of the intervention.
timeFrame: at the end of the intervention.
measure: Look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter (respiratory rate and rhythm) to the final measurement at the end of the intervention.
timeFrame: at the end of the intervention.
measure: Look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter (oxygen saturation level) to the final measurement at the end of the intervention.
timeFrame: at the end of the intervention.
measure: Look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter (blood pressure) to the final measurement at the end of the intervention.
timeFrame: at the end of the intervention.
measure: Look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter (pain level) to the final measurement at the end of the intervention.
timeFrame: at the end of the intervention.
measure: Look within groups at the change between the outcome measure from the pre-intervention baseline anxiety level to the final measurement at the end of the intervention.
timeFrame: at the end of the intervention.
measure: Compare both groups to the outcome of attention level at the end of the intervention.
timeFrame: after completing nine sessions of interventions one time on the last night shift of the third day.
Locations:
city: Alexandria
country: Egypt
facility: The cardiac care unit (CCU) of Smouha University Specialized Hospital
Study officials:
affiliation: Alexandria University
name: Sajeda Aref Shdaifat, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Azza Hamdi El-Soussi, Professor
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Mohamed Ibrahim Sanhoury, Assistant Professor
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Eman Arafa Ali, Lecturer
role: STUDY_DIRECTOR
References: