Side Effect of ChemotherapyNCT05475509
The Effect of Virtual Reality on Psychological Parameters in Patients Receiving Chemotherapy
A study testing Virtually reality in people with Side Effect of Chemotherapy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
It has been determined that after mastectomy, women have psychological problems such as deterioration of body image, fear of losing their feminine characteristics and sexual dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Side Effect of Chemotherapy
- What is being tested?
- Virtually reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- .Female patients who have had a mastectomy and will receive the first cure of outpatient chemotherapy
- Those between the ages of 18-75
- Willingness to participate in the research
- Absence of mental and communication problems
- No vision or hearing perception problem
Who cannot join
- Patients who stopped participating in the study
- Patients with mental and communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Some Physiological and Psychological Parameters in Patients Receiving Chemotherapy After Breast Surgery (Mastectomy)
It has been determined that after mastectomy, women have psychological problems such as deterioration of body image, fear of losing their feminine characteristics and sexual dysfunction. Chemotherapy treatment for the first time causes patients to feel hopeless, to experience uncertainty and anxiety, and to increase their stress level. Experiencing intense stress during this treatment process can lead to severe mental problems, which negatively affects the course of the disease and the response to treatment. Chemotherapy is a painful procedure. Pain and stress are symptoms that affect each other positively.
Virtual reality glasses, which is one of the distraction methods used in the control of symptoms; It is widely used in clinical medical care to relieve symptoms by offering the possibility to create therapeutic environments in the evaluation and treatment of medical conditions. By affecting the emotional, cognitive, behavioral and sociocultural dimensions of the individual, it increases the sense of control, activity level and work capacity, reduces stress, pain, anxiety level, feeling of powerlessness and side effects of pharmacological methods.
Read the detailed description
Breast cancer, which is common among women all over the world, draws attention in terms of mental and psychosocial aspects among cancer types because of the fear and anxiety of being cancer, as well as the loss of the breast, which appears as a symbol of femininity and sexuality, provides the nourishment of the baby, expresses love and motherhood feelings. type has been. Especially since it is a disease that evokes death, it creates more stress and anxiety in the individual compared to other diseases. In patients receiving chemotherapy after mastectomy, the side effects of the treatment, the treatment process, the fear of recurrence of the disease further increase the level of stress and anxiety. Nielsen, Zhang, Kristesen, and Schnohr, in their study examining the relationship between stress intensity and frequency, and breast cancer incidence, stated that women with high stress levels had a higher risk for breast cancer than women with low stress levels. Alacacioglu et al. The anxiety levels of female patients were found to be higher than male patients in their study with patients who were treated with chemotherapy. Karabulutlu et al., in their study with cancer patients, determined that 81.3% of cancer patients had depression and 61.5% had anxiety. In the study conducted by Aydoğan et al., the anxiety levels of cancer patients and healthy individuals were compared. found to be high. Non-pharmacological methods such as relaxation techniques, distraction, therapeutic touch, massage, hot-cold application, skin stimulation are used to reduce anxiety. In recent years, virtual reality as a distraction application has been widely used in clinical medical care to relieve pain. There are studies showing its effectiveness in pain and stress management in procedures such as injection applications, wound care, endoscopy procedure, phantom and chronic pain, chemotherapy applications. Schneider et al. During the chemotherapy treatment, videos were watched with virtual reality glasses to the patient with breast, lung and colon cancer who received chemotherapy treatment. It was determined that the anxiety and fatigue levels of the patients in the experimental group decreased and the time passed faster during the treatment process. Espinoza et al. Parks and nature walks were watched with virtual reality glasses in half-hour sessions consisting of four sessions for one week in 33 patients aged 41-85 years who were hospitalized in the oncology service and received chemotherapy treatment for metastatic cancer. After the application of virtual reality glasses, it was observed that the anxiety and depression levels of the patients decreased and the level of happiness increased.
According to the researchers' hypotheses, virtual reality acts as a non-pharmacological method, using cognitive and attentional processes on the body's complex pain modulation system. Although its neurobiological mechanisms have not been fully elucidated, studies have interestingly reported positive results in pain management. When patients feel that they are in the image, their attention is effectively distracted from the pain. Thus, the perception of pain is reduced. At the same time, distraction technique increases the patient's tolerance to pain, raises the pain threshold and causes him to feel less pain. This method, which is one of the independent practices of the nurse; It is a method frequently used in the current literature, as it is not an invasive procedure, is reliable, and has no known side effects. Although virtual reality is a potential and important technology in reducing the stress, pain and anxiety experienced during chemotherapy after mastectomy, there are limited or insufficient number of studies on this subject in our country. In the study of Toru, it was determined that virtual reality glasses applied during chemotherapy treatment in breast cancer patients reduced anxiety. In Karaman's study to determine the effect of virtual reality application on pain and anxiety during breast biopsy, found that virtual reality is effective on pain and anxiety.
However, unlike the studies conducted in this study, the stress level will be examined with saliva analysis and its relations with other parameters will be evaluated. There is no study directly related to this subject and it has been seen that a comprehensive study is needed. This research will be carried out to determine the effect of virtual reality on some physiological and psychological parameters in patients receiving chemotherapy after breast surgery. It is thought that the result of the research will contribute to the literature as an evidence-based non-pharmacological method in reducing the stress, pain and anxiety experienced during chemotherapy after mastectomy.
- Conditions
- Side Effect of Chemotherapy
- Being tested
- Virtually reality
- Keywords
- anxiety, pain, tension, oxygen saturation
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtually realityOther
Also called experimental-control group
Before chemotherapy, saliva samples will be taken from the control group, Personal Information Form, State Anxiety Scale and Visual Analogue Scale (VAS) pre-test questionnaires will be applied to the patients who accepted to participate in the study, vital signs measurements will be made and post-test questionnaires will be applied at the 30th minute of chemotherapy, vital signs measurements will be made, and A saliva sample will be taken. In the experimental group, a saliva sample will be taken before chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group (nature videos were watched by wearing virtual reality glasses) | Experimental | In the experimental group, saliva sample will be taken before chemotherapy, Personal Information Form, State Anxiety Scale and VAS pre-test questionnaires will be applied, pre-test questionnaires will be applied to measure vital signs, and then virtual reality glasses will be introduced to the patients and the duration will vary between 3-10 minutes for a total of 30 minutes. A saliva sample will be taken and a post-test will be applied, with virtual reality glasses, videos with music background, park, nature and seaside walks, underwater, museum trips, videos that the patient wants to watch and can change whenever they want. Each patient will be shown the same video. Receives: Other: Virtually reality |
| Control Group | No intervention | Personal Information Form, State Anxiety Scale and VAS pre-test questionnaires will be applied to the patients who accepted to participate in the study, saliva sample will be taken from the control group before chemotherapy, vital signs measurements will be made and post-test questionnaires will be applied at the 30th minute of chemotherapy, vital signs measurements will be made and saliva sample will be taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS):
VAS; It consists of a 10 cm long line starting with absence of pain (0) and ending with excruciating pain (10). The patient marks the severity of his pain on this line where he sees fit, this scale aims to explain the patient's pain in numbers.
Measured: up to 24 hours
Determination of Cortisol Level in Saliva:
The UPLC-MS/MS system will be used for the determination of cortisol in saliva. A reverse phase C18 column will be used for the determination of cortisol. A mixture of 5 mM ammonium acetate and methanol (25: 75, v/v) will be used as the mobile phase. The flow rate will be determined as 0.25 ml/min. The injection volume will be 5 µL and the column oven temperature will be 25 °C. In analyzes performed in MRM mode, 363.2→121.1 ions will be selected.
Measured: up to 24 hours
State-Trait Anxiety Inventory (STAI I-II):
The State-Trait Anxiety Inventory measures anxiety in adolescents over the age of 14 and adults. The scale, which is a type of self-assessment, includes 40 items consisting of short statements. 1-20 on the scale. questions, the state anxiety level of the individual, 21-40. The questions determine the level of trait anxiety. The total point value obtained from the inventory can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety.
Measured: up to 24 hours
Application Registration Form:
Pulse and oxygen saturation measurements of the patients before and after chemotherapy will be recorded in this form.
Measured: Investigators evaluate the change before and after chemotherapy in the 24-hour time frame.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 May 2020
- Primary completion1 May 2020
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Side Effect of ChemotherapyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research will be carried out by applying an experimental research design with a control group, pre-test-post-test applied, repetitive measurement.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesile Eskici Ilgin, Ataturk University
- Investigators
- Vesile Eskici İlgin, PhD, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475509
- Sponsor's protocol ID
- vesile25
- Status last verified
- Jan 2023
- First submitted
- 23 Jun 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Some Physiological and Psychological Parameters in Patients Receiving Chemotherapy After Breast Surgery (Mastectomy)
- ClinicalTrials.gov ID
- NCT05475509
- Acronym / sponsor ID
- vesile25
- Conditions
- Side Effect of Chemotherapy
- Keywords
- anxiety, pain, tension, oxygen saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been determined that after mastectomy, women have psychological problems such as deterioration of body image, fear of losing their feminine characteristics and sexual dysfunction. Chemotherapy treatment for the first time causes patients to feel hopeless, to experience uncertainty and anxiety, and to increase their stress level. Experiencing intense stress during this treatment process can lead to severe mental problems, which negatively affects the course of the disease and the response to treatment. Chemotherapy is a painful procedure. Pain and stress are symptoms that affect each other positively.
Virtual reality glasses, which is one of the distraction methods used in the control of symptoms; It is widely used in clinical medical care to relieve symptoms by offering the possibility to create therapeutic environments in the evaluation and treatment of medical conditions. By affecting the emotional, cognitive, behavioral and sociocultural dimensions of the individual, it increases the sense of control, activity level and work capacity, reduces stress, pain, anxiety level, feeling of powerlessness and side effects of pharmacological methods.
Detailed description
Breast cancer, which is common among women all over the world, draws attention in terms of mental and psychosocial aspects among cancer types because of the fear and anxiety of being cancer, as well as the loss of the breast, which appears as a symbol of femininity and sexuality, provides the nourishment of the baby, expresses love and motherhood feelings. type has been. Especially since it is a disease that evokes death, it creates more stress and anxiety in the individual compared to other diseases. In patients receiving chemotherapy after mastectomy, the side effects of the treatment, the treatment process, the fear of recurrence of the disease further increase the level of stress and anxiety. Nielsen, Zhang, Kristesen, and Schnohr, in their study examining the relationship between stress intensity and frequency, and breast cancer incidence, stated that women with high stress levels had a higher risk for breast cancer than women with low stress levels. Alacacioglu et al. The anxiety levels of female patients were found to be higher than male patients in their study with patients who were treated with chemotherapy. Karabulutlu et al., in their study with cancer patients, determined that 81.3% of cancer patients had depression and 61.5% had anxiety. In the study conducted by Aydoğan et al., the anxiety levels of cancer patients and healthy individuals were compared. found to be high. Non-pharmacological methods such as relaxation techniques, distraction, therapeutic touch, massage, hot-cold application, skin stimulation are used to reduce anxiety. In recent years, virtual reality as a distraction application has been widely used in clinical medical care to relieve pain. There are studies showing its effectiveness in pain and stress management in procedures such as injection applications, wound care, endoscopy procedure, phantom and chronic pain, chemotherapy applications. Schneider et al. During the chemotherapy treatment, videos were watched with virtual reality glasses to the patient with breast, lung and colon cancer who received chemotherapy treatment. It was determined that the anxiety and fatigue levels of the patients in the experimental group decreased and the time passed faster during the treatment process. Espinoza et al. Parks and nature walks were watched with virtual reality glasses in half-hour sessions consisting of four sessions for one week in 33 patients aged 41-85 years who were hospitalized in the oncology service and received chemotherapy treatment for metastatic cancer. After the application of virtual reality glasses, it was observed that the anxiety and depression levels of the patients decreased and the level of happiness increased.
According to the researchers' hypotheses, virtual reality acts as a non-pharmacological method, using cognitive and attentional processes on the body's complex pain modulation system. Although its neurobiological mechanisms have not been fully elucidated, studies have interestingly reported positive results in pain management. When patients feel that they are in the image, their attention is effectively distracted from the pain. Thus, the perception of pain is reduced. At the same time, distraction technique increases the patient's tolerance to pain, raises the pain threshold and causes him to feel less pain. This method, which is one of the independent practices of the nurse; It is a method frequently used in the current literature, as it is not an invasive procedure, is reliable, and has no known side effects. Although virtual reality is a potential and important technology in reducing the stress, pain and anxiety experienced during chemotherapy after mastectomy, there are limited or insufficient number of studies on this subject in our country. In the study of Toru, it was determined that virtual reality glasses applied during chemotherapy treatment in breast cancer patients reduced anxiety. In Karaman's study to determine the effect of virtual reality application on pain and anxiety during breast biopsy, found that virtual reality is effective on pain and anxiety.
However, unlike the studies conducted in this study, the stress level will be examined with saliva analysis and its relations with other parameters will be evaluated. There is no study directly related to this subject and it has been seen that a comprehensive study is needed. This research will be carried out to determine the effect of virtual reality on some physiological and psychological parameters in patients receiving chemotherapy after breast surgery. It is thought that the result of the research will contribute to the literature as an evidence-based non-pharmacological method in reducing the stress, pain and anxiety experienced during chemotherapy after mastectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research will be carried out by applying an experimental research design with a control group, pre-test-post-test applied, repetitive measurement.
| Arm | Type | Receives |
|---|---|---|
| virtual reality group (nature videos were watched by wearing virtual reality glasses) | Experimental | Other: Virtually realityIn the experimental group, saliva sample will be taken before chemotherapy, Personal Information Form, State Anxiety Scale and VAS pre-test questionnaires will be applied, pre-test questionnaires will be applied to measure vital signs, and then virtual reality glasses will be introduced to the patients and the duration will vary between 3-10 minutes for a total of 30 minutes. A saliva sample will be taken and a post-test will be applied, with virtual reality glasses, videos with music background, park, nature and seaside walks, underwater, museum trips, videos that the patient wants to watch and can change whenever they want. Each patient will be shown the same video. |
| Control Group | No intervention | –Personal Information Form, State Anxiety Scale and VAS pre-test questionnaires will be applied to the patients who accepted to participate in the study, saliva sample will be taken from the control group before chemotherapy, vital signs measurements will be made and post-test questionnaires will be applied at the 30th minute of chemotherapy, vital signs measurements will be made and saliva sample will be taken. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- .Female patients who have had a mastectomy and will receive the first cure of outpatient chemotherapy
- Those between the ages of 18-75
- Willingness to participate in the research
- Absence of mental and communication problems
- No vision or hearing perception problem
Key exclusion criteria (2 listed)
- Patients who stopped participating in the study
- Patients with mental and communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtually realityAlso: experimental-control groupBefore chemotherapy, saliva samples will be taken from the control group, Personal Information Form, State Anxiety Scale and Visual Analogue Scale (VAS) pre-test questionnaires will be applied to the patients who accepted to participate in the study, vital signs measurements will be made and post-test questionnaires will be applied at the 30th minute of chemotherapy, vital signs measurements will be made, and A saliva sample will be taken. In the experimental group, a saliva sample will be taken before chemotherapy. | Other | virtual reality group (nature videos were watched by wearing virtual reality glasses) |
Primary outcome
Visual Analogue Scale (VAS):
Time frame: up to 24 hours
VAS; It consists of a 10 cm long line starting with absence of pain (0) and ending with excruciating pain (10). The patient marks the severity of his pain on this line where he sees fit, this scale aims to explain the patient's pain in numbers.
Determination of Cortisol Level in Saliva:
Time frame: up to 24 hours
The UPLC-MS/MS system will be used for the determination of cortisol in saliva. A reverse phase C18 column will be used for the determination of cortisol. A mixture of 5 mM ammonium acetate and methanol (25: 75, v/v) will be used as the mobile phase. The flow rate will be determined as 0.25 ml/min. The injection volume will be 5 µL and the column oven temperature will be 25 °C. In analyzes performed in MRM mode, 363.2→121.1 ions will be selected.
State-Trait Anxiety Inventory (STAI I-II):
Time frame: up to 24 hours
The State-Trait Anxiety Inventory measures anxiety in adolescents over the age of 14 and adults. The scale, which is a type of self-assessment, includes 40 items consisting of short statements. 1-20 on the scale. questions, the state anxiety level of the individual, 21-40. The questions determine the level of trait anxiety. The total point value obtained from the inventory can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety.
Application Registration Form:
Time frame: Investigators evaluate the change before and after chemotherapy in the 24-hour time frame.
Pulse and oxygen saturation measurements of the patients before and after chemotherapy will be recorded in this form.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vesile Eskici İlgin, PhD principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtually reality in people with Side Effect of Chemotherapy, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS): (time frame: up to 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.