Back to resultsEffect of Virtual Reality on Pain, Anxiety, and Vital Signs of the Patients Undergoing Port Catheter Implantation
Primary Purpose
Pain, Anxiety, Blood Pressure
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Distraction
Sponsored by
About this trial
This is an interventional supportive care trial for Pain
Eligibility Criteria
Inclusion Criteria:
- aged 18 years and older, can communicate in Turkish, being diagnosed with cancer, and undergoing port catheter implantation.
Exclusion Criteria:
- being have chronic pain or anxiety disorders, using any type of analgesic or anxiolytic, and diagnosed with epilepsy were excluded from the study. The patients who have a visual impairment or also excluded from the study. Patients diagnosed with brain cancer or have brain metastasis were excluded from the study considering the potential seizures. During the intervention, the interventions were ended for the patients who experienced headache or dizziness (two most common problems caused by VR) and data of these patients were not included in the analysis.
Sites / Locations
- İnönü Üniversitesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
For the patients in this group, a virtual reality device was provided to the patients and patients wear it during the port catheter implantation and after the port catheter implantation when they felt pain.
For the patients in this group, there wasn't any specific intervention during or after the port catheter implantation.
Outcomes
Primary Outcome Measures
Pain Severity
A visual analog scale was used the examine the pain of the patients. Patients mark the severity of their experiences on 10 cm lines and the beginning of the line shows the lowest degree of the experience while the end of the line shows the highest. This scale is frequently used to determine the severity of the patient's pain. In this study, a 10 cm line was used to assess the severity of the patient's pain. While 0 reflects no pain, 10 reflects the highest severity of the pain. VAS was used for both groups before and after the port catheter implantation.
Anxiety
State anxiety inventory was used to examine the patients' anxiety. The scale was by Spielberger et al (1970). The Cronbach's Alpha internal consistency coefficients were range between .83 and .87. The State Anxiety Scale is a 20-item scale about how an individual feels at the moment. Originally, the scale consisted of two main domains, state anxiety, and trait anxiety. Only one of these two domains, state anxiety, was used in this study. The scores on the scale range between 20 and 80. Higher points reflect higher levels of anxiety. The scale was reported valid and reliable for Turkish society. The Cronbach's Alpha of the Turkish version was reported between 0.94 and 0.96. The scale was used for both groups before and after the port catheter implantation.
Blood Pressure (Systolic and Diastolic)
The blood pressure of the patients was assessed by using the Con-Tec CMS5100 device. The results presented as mmHg. The blood pressure measuring was administered for the patients in both groups.
Heart Rate
Heart rates were assessed by using the Con-Tec CMS5100 device. Beat per minute was used for comparison. Heart rates were measured for both groups.
Respiratory Rate
The respiratory rate was assessed by using the Con-Tec CMS5100 device. Respiration (inhalation and exhalation) per minute was used for comparison. The respiratory rate was measured for both groups.
O2 saturation
O2 saturation was assessed by using the Con-Tec CMS5100 device. O2% were used for comparison. O2 Saturation was measured for both groups.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05140707
Brief Title
Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of the Patients Undergoing Port Catheter Implantation
Official Title
The Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of Oncology Patients Undergoing Port Catheter Implantation: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to determine the effect of virtual reality on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. The study was carried out with 139 participants (69 intervention, 70 control) between September 2019 and January 2020. A patient identification form, state anxiety inventory, a table for vital signs, and a visual analog scale for pain severity were used for the data collection. Data were collected from the patients before, during, and after the implantation. In the intervention group, a virtual reality device, movies, and relaxing music were provided to the patients.
Detailed Description
To determine the effect of virtual reality (VR) on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. The study was a randomized controlled study. The study was carried out with 139 participants (69 intervention, 70 control) between September 2019 and January 2020. Data were collected before, during, and after the implantation by using a patient identification form, State Anxiety Inventory (SAI), a table for vital signs, and a visual analog scale for pain severity. In the intervention group, a virtual reality device, movies, and relaxing music were provided and patients were instructed to use it during the implantation and when they felt pain after the implantation. Data of the study were analyzed with IBM SPSS v25.0.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Blood Pressure, Body Temperature Changes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was of a randomized controlled design. There were two groups in the study; intervention and control. For the intervention group, the virtual reality distraction method was administered to the patients during the port catheter implantation in the intervention group while it wasn't administered to the patients in the control group.
Masking
Participant
Masking Description
There wasn't a masking in the study.
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
For the patients in this group, a virtual reality device was provided to the patients and patients wear it during the port catheter implantation and after the port catheter implantation when they felt pain.
Arm Title
Control
Arm Type
No Intervention
Arm Description
For the patients in this group, there wasn't any specific intervention during or after the port catheter implantation.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Distraction
Intervention Description
The patients were administered to use the virtual reality device and they were free to choose the theme and video in the library to watch. Patients used the device during the port catheter implantation and untill the 4 hour after the implantation when they felt pain.
Primary Outcome Measure Information:
Title
Pain Severity
Description
A visual analog scale was used the examine the pain of the patients. Patients mark the severity of their experiences on 10 cm lines and the beginning of the line shows the lowest degree of the experience while the end of the line shows the highest. This scale is frequently used to determine the severity of the patient's pain. In this study, a 10 cm line was used to assess the severity of the patient's pain. While 0 reflects no pain, 10 reflects the highest severity of the pain. VAS was used for both groups before and after the port catheter implantation.
Time Frame
Change from baseline pain severity at 4 hours
Title
Anxiety
Description
State anxiety inventory was used to examine the patients' anxiety. The scale was by Spielberger et al (1970). The Cronbach's Alpha internal consistency coefficients were range between .83 and .87. The State Anxiety Scale is a 20-item scale about how an individual feels at the moment. Originally, the scale consisted of two main domains, state anxiety, and trait anxiety. Only one of these two domains, state anxiety, was used in this study. The scores on the scale range between 20 and 80. Higher points reflect higher levels of anxiety. The scale was reported valid and reliable for Turkish society. The Cronbach's Alpha of the Turkish version was reported between 0.94 and 0.96. The scale was used for both groups before and after the port catheter implantation.
Time Frame
Change from baseline anxiety levels at 4 hours
Title
Blood Pressure (Systolic and Diastolic)
Description
The blood pressure of the patients was assessed by using the Con-Tec CMS5100 device. The results presented as mmHg. The blood pressure measuring was administered for the patients in both groups.
Time Frame
Change from the baseline blood pressure at 4 hours
Title
Heart Rate
Description
Heart rates were assessed by using the Con-Tec CMS5100 device. Beat per minute was used for comparison. Heart rates were measured for both groups.
Time Frame
change from baseline heart rate at 4 hours
Title
Respiratory Rate
Description
The respiratory rate was assessed by using the Con-Tec CMS5100 device. Respiration (inhalation and exhalation) per minute was used for comparison. The respiratory rate was measured for both groups.
Time Frame
change from baseline respiratory rate at 4 hours
Title
O2 saturation
Description
O2 saturation was assessed by using the Con-Tec CMS5100 device. O2% were used for comparison. O2 Saturation was measured for both groups.
Time Frame
change from baseline O2 saturation at 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18 years and older, can communicate in Turkish, being diagnosed with cancer, and undergoing port catheter implantation.
Exclusion Criteria:
being have chronic pain or anxiety disorders, using any type of analgesic or anxiolytic, and diagnosed with epilepsy were excluded from the study. The patients who have a visual impairment or also excluded from the study. Patients diagnosed with brain cancer or have brain metastasis were excluded from the study considering the potential seizures. During the intervention, the interventions were ended for the patients who experienced headache or dizziness (two most common problems caused by VR) and data of these patients were not included in the analysis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuğba Menekli, Ph.D.
Organizational Affiliation
Tuğba Menekli
Official's Role
Study Director
Facility Information:
Facility Name
İnönü Üniversitesi
City
Malatya
ZIP/Postal Code
44100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of the Patients Undergoing Port Catheter Implantation
We'll reach out to this number within 24 hrs