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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215066
• Other study ID #: Distraction Techniques
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Alexandria University
• Contact: Sajeda Aref Shdaifat, PhD Student
• Phone: +201091081189
• Email: sajeda.nursing1993[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Modified Progressive Muscle Relaxation Exercise
The modified progressive muscle relaxation technique will be applied through muscle relaxation to a specific part of the body.

Device:
• The virtual reality box
a virtual reality box (VR- box) with 3D glasses (eye goggles)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the degree of changes between baseline physiological parameter (temperature ) and post-intervention scores.	compare the degree of changes between baseline physiological parameter including temperature by Celsius and post-intervention scores.	immediately after the intervention.
Other	Compare the degree of changes between baseline physiological parameter (heart rate) and post-intervention scores.	compare the degree of changes between baseline physiological parameter including heart rate by beats/minutes and rhythm regular or irregular, and post-intervention scores.	immediately after the intervention.
Other	Compare the degree of changes between baseline physiological parameter (respiratory rate) and post-intervention scores.	compare the degree of changes between baseline physiological parameter including respiratory rate by breaths/minutes and rhythm regular or irregular, and post-intervention scores.	immediately after the intervention.
Other	Compare the degree of changes between baseline physiological parameter (oxygen saturation level) and post-intervention scores.	compare the degree of changes between baseline physiological parameter including oxygen saturation level by percent (%), and post-intervention scores.	immediately after the intervention.
Other	Compare the degree of changes between baseline physiological parameter (blood pressure) and post-intervention scores.	compare the degree of changes between baseline physiological parameter including blood pressure by millimeters of mercury (mmHg) , and post-intervention scores.	immediately after the intervention.
Other	Compare the degree of changes between baseline physiological parameter (pain level) and post-intervention scores.	compare the degree of changes between baseline physiological parameter including pain level by Numerical Rating Scale (NRS) from 0 to 10, and post-intervention scores.	immediately after the intervention.
Other	Compare the degree of changes between baseline anxiety level and post-intervention scores.	compare the degree of changes between baseline anxiety level by using the Hamilton Anxiety Rating Scale (HAM-A), the total score of each item ranges from 0 to 56. A score where <17 indicates mild severity, from 18 to 24 is mild to moderate severity, and from 25 to 30 is moderate to severe, and post-intervention scores.	immediately after the intervention.
Other	Look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter (temperature) to the final measurement at the end of the intervention.	look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter including temperature by Celsius to the final measurement at the end of the intervention.	at the end of the intervention.
Other	Look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter (heart rate) to the final measurement at the end of the intervention.	look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter including heart rate by beats/minutes and rhythm regular or irregular, to the final measurement at the end of the intervention.	at the end of the intervention.
Other	Look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter (respiratory rate) to the final measurement at the end of the intervention.	look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter including respiratory rate by breaths/minutes and rhythm regular or irregular, to the final measurement at the end of the intervention.	at the end of the intervention.
Other	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.	look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter including oxygen saturation level by percent (%), to the final measurement at the end of the intervention.	at the end of the intervention.
Other	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.	look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter including blood pressure by millimeters of mercury (mmHg) to the final measurement at the end of the intervention.	at the end of the intervention.
Other	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.	look within groups at the change between the outcome measure from the pre-intervention baseline physiological parameter including pain level by Numerical Rating Scale (NRS) from 0 to 10, to the final measurement at the end of the intervention.	at the end of the intervention.
Other	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.	look within groups at the change between the outcome measure of anxiety level from the pre-intervention baseline by using the Hamilton Anxiety Rating Scale (HAM-A), the total score of each item ranges from 0 to 56. A score where <17 indicates mild severity, from 18 to 24 is mild to moderate severity, and from 25 to 30 is moderate to severe, to the final measurement at the end of the intervention.	at the end of the intervention.
Other	Compare both groups to the outcome of attention level at the end of the intervention.	compare both groups to the outcome of attention level by using Attention and Distraction Scale, A high score on the scale denotes a high level of attention and distraction from the environment, whereas a low score denotes a low level of attention and distraction from the environment. The maximum score on the attention and distraction scale is 100, while the minimum score is 20.	after completing nine sessions of interventions one time on the last night shift of the third day.
Primary	Comparing the outcomes of the physiological parameter (temperature) for both groups.	Measures the physiological parameter including temperature by Celsius.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
Primary	Comparing the outcomes of the physiological parameter (heart rate) for both groups.	Measures the physiological parameter including heart rate by beats/minutes and rhythm regular or irregular.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
Primary	Comparing the outcomes of the physiological parameter (respiratory rate) for both groups.	Measures the physiological parameter including respiratory rate by breaths/minutes and rhythm regular or irregular.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
Primary	Comparing the outcomes of the physiological parameter (oxygen saturation level) for both groups.	Measures the physiological parameter including oxygen saturation level by percent (%).	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
Primary	Comparing the outcomes of the physiological parameter (pain level) for both groups.	Measures the physiological parameter including pain level by Numerical Rating Scale (NRS) from 0 to 10.	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
Primary	Comparing the outcomes of the physiological parameter (blood pressure) for both groups.	Measures the physiological parameter including blood pressure by millimeters of mercury (mmHg).	The physiological parameters baseline (pre intervention) will be assessed individually for each patient.
Primary	Comparing the outcomes of the anxiety level for both groups.	Measures the anxiety level by using the Hamilton Anxiety Rating Scale (HAM-A), the total score of each item ranges from 0 to 56. A score where <17 indicates mild severity, from 18 to 24 is mild to moderate severity, and from 25 to 30 is moderate to severe.	The anxiety level baseline (pre intervention) will be assessed individually for each patient.
Secondary	Comparing the outcomes of the physiological parameter (temperature) for both groups.	Measures the physiological parameter before and after the intervention including temperature by Celsius.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
Secondary	Comparing the outcomes of the physiological parameter (heart rate) for both groups.	Measures the physiological parameter before and after the intervention including heart rate by beats/minutes and rhythm regular or irregular.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
Secondary	Comparing the outcomes of the physiological parameter (respiratory rate) for both groups.	Measures the physiological parameter before and after the intervention including respiratory rate by breaths/minutes and rhythm regular or irregular.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
Secondary	Comparing the outcomes of the physiological parameter (oxygen saturation level) for both groups.	Measures the physiological parameter before and after the intervention including oxygen saturation level by percent (%).	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
Secondary	Comparing the outcomes of the physiological parameter (blood pressure) for both groups.	Measures the physiological parameter before and after the intervention including blood pressure by millimeters of mercury (mmHg).	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
Secondary	Comparing the outcomes of the physiological parameter (pain level) for both groups.	Measures the physiological parameter before and after the intervention including pain level by Numerical Rating Scale (NRS) from 0 to 10.	5 minutes before the intervention and after the intervention immediately for one time on the morning, evening and night shift for three consecutive days.
Secondary	Comparing the outcomes of the anxiety level for both groups.	Measures the anxiety level before the intervention by using the Hamilton Anxiety Rating Scale (HAM-A), the total score of each item ranges from 0 to 56. A score where <17 indicates mild severity, from 18 to 24 is mild to moderate severity, and from 25 to 30 is moderate to severe.; Measures the anxiety level after the intervention by using the Hamilton Anxiety Rating Scale (HAM-A), the total score of each item ranges from 0 to 56. A score where <17 indicates mild severity, from 18 to 24 is mild to moderate severity, and from 25 to 30 is moderate to severe.	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.