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Completed

NCT Number: NCT05140707

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

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Blood Pressure Body Temperature Changes Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İnönü Üniversitesi

Malatya, 44100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Distraction

Other

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 outcomes

  1. Pain Severity

    Time frame: Change from baseline pain severity at 4 hours

    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.

  2. Anxiety

    Time frame: Change from baseline anxiety levels at 4 hours

    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.

  3. Blood Pressure (Systolic and Diastolic)

    Time frame: Change from the baseline blood pressure at 4 hours

    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.

  4. Heart Rate

    Time frame: change from baseline heart rate at 4 hours

    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.

  5. Respiratory Rate

    Time frame: change from baseline respiratory rate at 4 hours

    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.

  6. O2 saturation

    Time frame: change from baseline O2 saturation at 4 hours

    O2 saturation was assessed by using the Con-Tec CMS5100 device. O2% were used for comparison. O2 Saturation was measured for both groups.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 1, 2021
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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