Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of the Patients Undergoing Port Catheter Implantation

Pain Clinical Trial

Official title:

The Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of Oncology Patients Undergoing Port Catheter Implantation: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140707
• Other study ID #: VRonPainAnxietyVitalSigns
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: November 2021
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Blood Pressure
• Body Temperature Changes
• Pain

Intervention

Other:
• Virtual Reality Distraction
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.

Locations

Country	Name	City	State
Turkey	Inönü Üniversitesi	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline pain severity at 4 hours
Primary	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.	Change from baseline anxiety levels at 4 hours
Primary	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.	Change from the baseline blood pressure at 4 hours
Primary	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.	change from baseline heart rate at 4 hours
Primary	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.	change from baseline respiratory rate at 4 hours
Primary	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.	change from baseline O2 saturation at 4 hours