Clinical trial NCT05140707: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Blood Pressure
Body Temperature Changes
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain Severity
timeFrame: Change from baseline pain severity at 4 hours
measure: Anxiety
timeFrame: Change from baseline anxiety levels at 4 hours
measure: Blood Pressure (Systolic and Diastolic)
timeFrame: Change from the baseline blood pressure at 4 hours
measure: Heart Rate
timeFrame: change from baseline heart rate at 4 hours
measure: Respiratory Rate
timeFrame: change from baseline respiratory rate at 4 hours
measure: O2 saturation
timeFrame: change from baseline O2 saturation at 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: İnönü Üniversitesi
Study officials:
affiliation: Tuğba Menekli
name: Tuğba Menekli, Ph.D.
role: STUDY_DIRECTOR
References: