Introduction
Breast cancer is the most common cancer among females worldwide (McGuire et al., Reference McGuire, Brown and Malone2015; Siegel et al., Reference Siegel, Miller and Jemal2016). Cancer patients suffer from a large number of intense physical and psychological symptoms, including pain and anxiety, which are accompanied by declines in physical and psychological health regardless of the stage of the disease (Sivabalan & Upasani, Reference Sivabalan and Upasani2016). In about 50% of cancer patients who are in pain, few of the available painkillers achieve adequate pain relief (Wiederhold et al., Reference Wiederhold, Gao and Sulea2014).
Inadequate treatment for pain among adult patients with cancer leads to health deterioration and difficult cancer treatment (Ahmad et al., Reference Ahmad, Alasad and Nawafleh2010). Unfortunately, according to the Jordan Initiative for Pain Management in 2010, about 50% of patients with cancer complained of constant pain. Ovayolu et al. (Reference Ovayolu, Ovayolu and Serçe2013) showed that cancer pain is complex and has multidimensional behavioral, emotional, cognitive, and sensory components. Recently, pain management research started to give more attention to nonpharmacological interventions (Ahmad et al., Reference Ahmad, Dardas and Ahmad2015; Shahrbanian et al., Reference Shahrbanian, Ma and Korner-Bitensky2009).
Cancer pain management includes pharmacological and nonpharmacological methods (Portenoy, Reference Portenoy2011). First, pharmacological pain management involves the use of medications, either alone or in combination with other types of therapy. Three main classes of medication include nonopioid, adjuvant analgesics, and opioid. Opioid types include morphine, which is the most commonly used medication for moderate and severe cancer pain; at the same time, moderate to severe pain is the most common among cancer patients, and about 70–80% of patients with advanced disease are affected by moderate to severe pain (Caraceni et al., Reference Caraceni, Hanks and Kaasa2012). Other opioids used include pethidine, fentanyl, codeine, oxycodone, hydromorphone, methadone, and tramadol. The side effects of opioids include constipation, which is the most common, nausea and vomiting, dry mouth, respiratory depression, sedation, hallucination, drowsiness, urticaria, pruritus, and myoclonic jerking (Ferrell et al., Reference Ferrell, Coyle and Paice2015). Second, nonpharmacological interventions have two classifications. The first is the peripheral therapies that have physical agents such as hot-cold treatment, transcutaneous electrical nerve stimulation, acupuncture, acupressure, massage, hydrotherapy, and exercise. The second classification is cognitive-behavioral therapies such as relaxation, meditation, praying, yoga, hypnosis, biofeedback, and distraction (Demir, Reference Demir2012). Furthermore, it is important that analgesics should be given on a regular basis and according to the World Health Organization ladder. The World Health Organization introduced the analgesic ladder in 1986, and it includes a three-step methodology for the use of pharmacological agents corresponding with the pain's severity as described by the patients as mild, moderate and sever pain (World Health Organization, 2017).
According to Merriam-Webster (2017), distraction is something that entertains a person and makes it hard for that person to pay attention or think about problems or pains. Furthermore, distraction is a simple nonpharmacological technique that does not need any specific training and can be implemented by nurses (Buratt et al., Reference Buratt, Angelino and Sansoni2015). Additionally, distraction reduces the perception of pain by altering the nociceptive responses (Haraldstad et al., Reference Haraldstad, Sørum and Eide2011).
Anxiety is an emotion characterized by subjectively unpleasant feelings of worries over anticipated events or future threats, such as the feeling of imminent death (Davison & Gerald, Reference Davison and Gerald2008). In 2015, Ferrell et al. defined anxiety as “a vague, subjective feeling of apprehension, tension, insecurity, and uneasiness, usually without a known, specific cause identifiable by the individual” (p. 394). Anxiety is classified into state anxiety, which is related to a temporary condition, and trait anxiety, which has a long-standing quality (Spielberger, Reference Spielberger2012). Anxiety among cancer patients could arise from different reasons such as a reaction to cancer diagnosis, severe pain, long-term treatments, treatment's side effects, and feeling of burden or dependence on others (Arrieta et al., Reference Arrieta, Angulo and Nunez-Valencia2013; Lim et al., Reference Lim, Devi and Ang2011). Furthermore, anxiety results from failure to control the adverse effects of cancer treatments that are available in Jordan, and among patients who had little or no control over their health (Omran et al., Reference Omran, Saeed and Simpson2012). Anxiety has negative effects on the treatment of cancer patients (Beikmoradi et al., Reference Beikmoradi, Najafi and Roshanaei2015), which leads to delay in patients’ healing. For that, anxiety relief for cancer patients should be started immediately after cancer diagnosis and continued until the end of the treatment, with follow-up to support treatment progression (Khan et al., Reference Khan, Ward and Watson2010). Spencer et al. (Reference Spencer, Nilsson and Wright2010) found that anxiety relief among cancer patients can improve their interaction with family, caregivers, and friends, with improvement in their social, cognitive, and emotional functions.
Anxiety treatment of cancer patients can use pharmacological and nonpharmacological methods, however (Ferrell et al., Reference Ferrell, Coyle and Paice2015). The use of benzodiazepine drugs to treat anxiety has side effects, including the potential to create tolerance, dependence, and drug interactions. For that reason, nonpharmacological interventions for anxiety treatment were deemed safer (Platt et al., Reference Platt, Whitburn and Platt-Koch2016).
Nonpharmacological anxiety-relieving methods include exercising, deep breathing, imagery, and relaxation techniques (Ferrell et al., Reference Ferrell, Coyle and Paice2015). The use of distraction was effective in reducing anxiety (Hudson et al., Reference Hudson, Ogden and Whiteley2015). According to Cherry and Jacob (Reference Cherry and Jacob2016), new clinical treatments emphasize the use of nonpharmacological approach with nursing care to support healing through improving cancer patients' social, cognitive, and emotional functions.
Virtual reality (VR) technology is a form of distraction defined as a noninvasive simulation technology with the three dimensions of width, height, and depth that were generated digitally in a computer-generated environment that allows a user to interact with it (Moskaliuk et al., Reference Moskaliuk, Kimmerle, Cress and Murugesan2010). VR systems are categorized into two types, the immersive and nonimmersive (Chirico et al., Reference Chirico, Lucidi and De Laurentiis2016). Immersive VR is characterized by full immersion, which is reached by a head-mounted display, and distracts the patient by presenting them with a view of a computer-generated world instead of the real world (Chirico et al., Reference Chirico, Lucidi and De Laurentiis2016). In 2008, Jennett et al. defined immersion as a “lack of awareness of time, a loss of. The nonimmersive type is characterized by computer screen where the user can communicate with the external world at the same time he is connected to the virtual world (Chirico et al., Reference Chirico, Lucidi and De Laurentiis2016).”
VR was helpful in drawing patients' attention away from mental processing and to decrease the amount of pain (Wiederhold et al., Reference Wiederhold, Gao and Sulea2014). VR as a distraction technique was effective in decreasing pain and anxiety among burn injury patients undergoing wound dressing changes and physiotherapy management (Morris et al., Reference Morris, Louw and Grimmer-Somers2009). Virtual reality is also used during chemotherapy infusion to relieve cancer discomfort (Chirico et al., Reference Chirico, Lucidi and De Laurentiis2016). The immersive VR technology acts as a nonpharmacologic type of analgesia throughout a collection of emotional-affective, emotion-based cognitive, and attentional processes in the body-involved pain modulation system (Li et al., Reference Li, Montaño and Chen2011).
The purposes of this study were as follows. (1) compare the pain score between patients receiving standard care, which includes pharmacological interventions (oral or intravenous morphine) alone, with patients receiving standard care plus VR technology among females who are diagnosed with breast cancer with chronic pain. (2) Compare anxiety level between patients receiving standard care, which includes pharmacological interventions (oral or intravenous morphine) alone, with patients receiving standard care plus VR technology among females who are diagnosed with breast cancer with chronic pain.
Methods
Design and setting
A randomized control trial design was used in this study. Participants were recruited from specialized cancer center in Jordan in the medical and surgical wards. The setting is a comprehensive cancer center and a model for palliative care and pain relief in the Middle East.
Sample
The sample size was calculated using the G. Power program for the independent sample t test (Faul et al., Reference Faul, Erdfelder and Lang2007). Based on a significance level of 0.05, medium effect size 0.5, and power of 0.80, a minimum of 34 participants per group was needed.
This study included 80 female patients (40 in each group) with breast cancer. Four patients refused to participate for reasons such as having no time and not interested; thus, the response rate was 95%. Random assignment was done based on flipping coin; if heads, then the first participant would be placed in the intervention group. The rest of the participants were placed in the study groups by the order of meeting the eligibility criteria.
Instruments
Pain measurement
A visual analog scale (VAS) was used to measure pain; it was a 10-cm scale considered to evaluate the patients' pain intensity, with the anchors from no pain (0) to the worst possible pain (10) (Gagnon et al., Reference Gagnon, Stanos and van der Ende2013). The VAS is a valid and reliable measurement of pain intensity among patients with cancer (Jensen, Reference Jensen2003).
Anxiety measurement
The State Anxiety Inventory (SAI) is a valid and commonly used measure for anxiety (Balsamo et al., Reference Balsamo, Romanelli and Innamorati2013). Patients' anxiety levels were measured using the SAI for adults (Spielberger et al., Reference Spielberger, Gorsuch and Lushene1983). The SAI includes 20 items; each item is scored on a 4-point Likert scale (1 = almost never, 2 = occasionally, 3 = most of the time, and 4 = almost always). The SAI range of total scores is between 20 and 80, with the higher score indicating more anxiety (Beikmoradi et al., Reference Beikmoradi, Najafi and Roshanaei2015). The State Anxiety Scale, rather than trait anxiety, was used in this study because it evaluates the current feeling of anxiety by using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system (Julian, Reference Julian2011).
The cognitive function was assessed by the principal investigator (PI) using the Mini-Mental State Examination (MMSE). The Arabic version of the MMSE was validated in a study that screened for cognitive impairment among hospitalized adults (Wrobel & Farrag, Reference Wrobel and Farrag2012). The MMSE takes only 5 to 10 minutes to use and includes 11 questions. The maximum score is 30; a score of ≤23 means there is a cognitive impairment (Kurlowicz & Wallace, Reference Kurlowicz and Wallace1990).
Data collection procedure
Data collection was expanded over 4 months. The inclusion criteria were: being a female patient diagnosed with breast cancer, age between 18 and 70 years, having chronic pain, able to read and write, having no clinical evidence of primary or metastatic disease to the brain or history of seizure, no history of motion sickness, on intravenous morphine or oral analgesics, no significant hearing or visual impairments, and cognitively able to participate. The eligibility criteria were explained to the head nurses in the study setting, which helped in referring patients to the PI of the study.
Before starting data collection, the PI visited the cancer center to determine the most common type of painkiller used with cancer patients, which was morphine; then, the peak time of the effects of this painkiller was used to determine the time-point for anxiety and pain reassessment. Based on the literature, the peak effect for oral morphine occurs within 30 minutes and the peak effect for intravenous morphine occurs within 20 minutes (Trescot et al., Reference Trescot, Datta and Lee2008).
The study was then explained to the participants by providing information about VR for the intervention group only. When the approached patients agreed to participate, patients’ cognitive function was assessed by the PI using the MMSE. Furthermore, to determine the patients in pain, different readings from the patient's profile were taken to expect the time of pain starting for patients with chronic pain. The majority of the participants (n = 61, 76%) were in the second and third stages of cancer.
The intervention group chose from two scenarios on a CD-ROM, which included deep sea diving “Ocean Rift,” or sitting on the beach with the “Happy Place” track (Chirico et al., Reference Chirico, Lucidi and De Laurentiis2016). The scenarios were assessed in a pilot study to determine if they were comfortable and clear. Then, the patients wore a head-mounted display with headphones. The PI remained near the participants during the VR session. The VR exposure session was ended at the peak time of painkiller efficacy. The reason for selecting the peak time was to standardize the time of reassessing pain and anxiety level.
The data were collected by the PI using the VAS to determine pain level and the SAI to assess anxiety level. For more accuracy, pain and anxiety ratings were assessed at two points of time for each group as follows: For the intervention group, exactly before giving the morphine and after finishing the VR session (which started exactly at the peak time effect for 15 minutes), which means that the reassessment was done 15 minutes from the peak time effect. The assessment for the comparison group was done just before giving the morphine and at 15 minutes after the peak time effect.
Ethical considerations
Approvals from the ethics committees and the relevant hospitals were obtained. A consent form was signed by each participant. Permission was sought from the participants to obtain access to the data in their medical records, which included information about the cancer type, stage, time since diagnosis, and painkiller type and route. Furthermore, the participants in the control group were given the opportunity to use VR after they completed their role in the study.
Results
The Statistical Package for the Social Sciences 21 program (IBM Corporation, 2012) was used to manage the data. Fifty-five participants (68.8%) were receiving intravenous painkillers, whereas the rest had oral painkillers. The mean for painkiller dose in the intravenous route was 4.24 mg (SD = 2.42), ranging from 1 to 10 mg; the mean for pain killer dose in the oral route was 22.6 mg (SD = 9.70), ranging from 5 to 30 mg.
Patients' characteristics
The participants' mean age was 51.99 years (SD = 10.34), with a range from 30 to 70 years. There was no significant difference in the time since diagnosis (p = 0.34), morphine dose (p = 0.11), treatment type (p = 0.06), marital status (p = 0.15), educational level (p = 0.16), and cancer stage (p = 0.64) between the intervention and comparison groups. There was no significant difference in pain score and anxiety score preintervention between the two groups (Table 1).
Comparison of patients' characteristics according to group membership
JD, Jordanian dinar ($US1.4).
The independent sample t test showed a significant difference postintervention between the two groups’ pain scores. The intervention group mean was 0.33 (SD = 0.82), and the control group mean was 4.84 (SD = 2.57) (t = –9.19, p < 0.001). The paired sample t test also showed a significant difference in the means of pain scores at the pre- and posttest in intervention group and the control group (Table 2).
Paired sample t test for the mean differences in the pain scores for the study groups
DF, degrees of freedom.
Regarding the anxiety testing, the independent sample t test showed a significant difference postintervention between the two groups. The intervention group mean was 37.68 (SD = 3.80); the control group mean was 50.13 (SD = 9.32) (t = –7.83, p < 0.001). The paired sample t test for testing anxiety levels showed a significant difference in the mean scores at the pre- and posttest in intervention group and the control group (Table 3).
Paired sample t test for mean differences in the anxiety scores for the study groups
DF, degrees of freedom.
Although we could not pinpoint the exact reason VR brought about pain relief, we assumed that it was that patients’ attention was focused on the game, and that the game brought about feelings of joy.
Discussion
Although the benefits of VR are well recognized in the literature, there is limited knowledge at national and international levels on the effects of VR technology on pain and anxiety among female patients with breast cancer. We agree with Chirico et al. (Reference Chirico, Lucidi and De Laurentiis2016) in their argument that VR worked because pain requires conscious attention. Being transferred into another world with VR draws the patient's attention, leaving less attention available to process pain signals. We assume that the patient's attention in our study was focused on the chosen scenario track, which brought feelings of joy. This is important in the Arab world because no studies had yet examined the effectiveness of immersive VR technology on patients with breast cancer in Jordan or any other Arab country (Ahmad & Dardas, Reference Ahmad, Dardas, Fitzpatrick and Whall2016). In addition, the current study is important because it could be the first to test the effectiveness of immersive VR on relieving pain and anxiety among patients with breast cancer, with a focus on type morphine as a painkiller.
About 63% of the participants' ages were 50 years and above, with a range from 30 to 70 years. This is consistent with the statistics on breast cancer from Jordan Cancer Society, which reported that breast cancer is the most common type among females of this age (JCR, 2013). This study has focused on female patients with breast cancer, unlike other studies that used VR on both genders and with more than one type of cancer (Baños et al., Reference Baños, Espinoza and García-Palacios2013; Schneider et al., Reference Schneider, Kisby and Flint2011).
The response rate of 95% in this study is higher than those reported in other VR studies (Baños et al., Reference Baños, Espinoza and García-Palacios2013). This may indicate that the patients who were invited to participate in this study were in need of such an intervention, and possibly because of inadequate treatment of cancer pain in Jordan (Ahmad et al., Reference Ahmad, Alasad and Nawafleh2010; Al Qadire et al., Reference Al Qadire, Tubaishat and Aljezawi2013). Other factors may have enhanced participation in the current intervention, such as short duration of VR session and being excited for exposure to a new technology. However, only the intervention group was exposed to VR during the study; the participants in the control group who showed interest in VR got the chance to participate after their role in the study was completed.
Immersive VR technology in the current study significantly reduced patients' pain and anxiety levels. The mean of pain score in the intervention group was lower than the comparison group after the intervention. This findings support the work of other researchers who used VR distraction interventions during painful procedures (Chan & Scharf, Reference Chan and Scharf2017; Gromala et al., Reference Gromala, Tong and Choo2015; Pandya et al., Reference Pandya, Kim and Howard2017).
In this study, there was a significant difference in pain scores between the pretest and posttest in the intervention group, which is consistent with a previous VR study on noncancer patients (Hoffman et al., Reference Hoffman, Richards and Van Oostrom2007). Our findings contradict a previous study by Chan et al. (Reference Chan, Chung and Wong2007), in which there was no total immersion and involvement, which may resulted from an uncomfortable position, tiredness, and disturbance by the hospital environment.
In the current study, participants in the comparison group had lower pain scores in posttest than pretest. However, when comparing the results with the intervention group, the t statistics increased from t = 8.2 in the comparison group to t = 25.57 in the intervention group. This means that the use of VR with morphine in the intervention group reduced pain significantly more than pharmacological intervention alone in the control group. This is consistent with the literature that morphine alone can reduce pain level but that the use of VR and morphine together were more effective in pain reduction (Hoffman et al., Reference Hoffman, Richards and Van Oostrom2007).
All patients in this study had anxiety; their scores were above the cutoff level of 39 (Knight et al., Reference Knight, Waal-Manning and Spears1983). Immersive VR was an effective distraction technique in this study for anxiety level, which is consistent with VR studies among other populations (Gromala et al., Reference Gromala, Tong and Choo2015; Marquess et al., Reference Marquess, Johnston and Williams2017). The effect of VR distraction in the current study was different from other VR studies, which found no effect on anxiety level (Chirico et al., Reference Chirico, Lucidi and De Laurentiis2016; Morris et al., Reference Morris, Louw and Grimmer-Somers2009). This could be explained by the small sample size in other studies. In our study, the Cohen's D effect size was large enough (2.36) for pain score and (1.75) anxiety score, which supports our result of the differences between the two groups. In addition, the VR equipment and software has become more advanced over time in providing better distraction effect.
The participants in both groups had lower anxiety scores in posttest than pretest; however, there was a significant difference in favor of the intervention group in the reduction of anxiety level. This indicates that morphine reduced anxiety, but when VR was added, more benefits in anxiety relief were recorded. This is consistent with the literature; many studies on patients with a diagnosis other than breast cancer demonstrate that the use of VR could relieve anxiety (Baños et al., Reference Baños, Espinoza and García-Palacios2013; Gromala et al., Reference Gromala, Tong and Choo2015).
This study supports the use of immersive VR as an effective and safe nonpharmacological method for distracting patients from anxiety. Opioids are widely prescribed to reduce patients’ pain, but they are also could lead to drug addiction. Other side effects could include nausea, headache, dizziness, constipation, and weakness (Demir, Reference Demir2012). This means that the use of VR may reduce the side effects of anxiolytic medication as the nonpharmacological treatment was safer than medications for anxiety treatment (Platt et al., Reference Platt, Whitburn and Platt-Koch2016).
We think that there were many factors that supported the conduction of this study. The equipment required to implement the intervention was convenient for participants in the intervention group. Furthermore, this technology is useful and easy to use, making it feasible for patient self-use after discharge if they want to continue its use. Moreover, the intervention was noninvasive with no side effects, and if implemented in future interventions, will reduce pharmacological side effects. This is an important point because it may increase the patients’ level of acceptance, especially for those who are reluctant to use medication because of its side effects.
Implications and recommendations
Some patients in this study suggested increasing the time of VR session to distract them during hospitalization. This suggestion should be considered in future research, which should measure the effectiveness of VR along with other diagnoses. Research should compare VR with other distraction techniques such as imagination, music, and art therapy. A qualitative study that supports in-depth examination of patients' experiences during VR sessions is also recommended for assessing and improving VR user interface and user interaction. Moreover, qualitative study could explore how the feelings of pain and anxiety change and for how long the effect could extend. Further research is recommended to examine that, if patients have the VR equipment at home, whether it would be feasible to use it frequently without hindering the activities of daily living.
Conclusion
VR is appropriate for nurses because it is not dependent on a doctor's prescription; however, as with other treatments, this intervention should be used with caution because it may cause motion sickness. Clinicians should instruct patients to discontinue VR if any side effects are experienced. Clinicians should assume that the use of VR will decrease cancer-related pain and anxiety symptoms. Immersive VR was a safe nonpharmacological intervention because none of the participants, who were selected based on the eligibility criteria reported any unusual symptoms, such as dizziness, increased nausea, or visual disturbances. Managing pain and anxiety is a key factor in improving patients' health. The findings of this study suggest that immersive VR holds promise as an effective distraction intervention for managing pain and anxiety among breast cancer patients. Using immersive VR as an adjuvant is more effective than morphine alone in relieving pain and anxiety. It is likely that this is the first study to show that immersive VR as feasible, effective, and acceptable in the Arab world. This study had some limitations, such as the cost of the equipment being relatively expensive, and the findings can only be generalized to female breast cancer patients who received morphine as a painkiller.
Acknowledgment
This study was funded by the Deanship of Scientific Research at the University of Jordan. We would like to thank Mr. Abdullah Obaid from King Hussein Cancer Center for his help and motivation during data collection.
