Hot FlashesNCT04414033
Bubble: A New VR-AI Way of Treatment for Hot Flashes in Women With Breast Cancer
A study testing Bubble: A New VR-AI Way of Treatment for Hot Flashes in people with Hot Flashes and Breast Cancer, run by Bar-Ilan University, Israel at 1 site in Israel.
Trial summary
This study evaluates the potential of a unique artificial intelligence-virtual reality intervention called Bubble, to reduce the number and intensity of hot flashes and their accompanying psychological symptoms in women, aged 28-55, with breast cancer. Read more about this study
- Who is it for?
- Ages 28 to 55 years, women only
- Conditions the study is for
- Hot Flashes, Breast Cancer
- What is being tested?
- Bubble: A New VR-AI Way of Treatment for Hot Flashes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2018to 28 Feb 2019
- 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 28 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females between the ages of 18 and 60
- Having an existing diagnosis of breast or ovarian cancer
- Receiving standard-of-care chemotherapy, endocrine therapy or estrogen blocking anti-cancer treatment
- The woman reported experiencing hot flashes at least once per day for a duration of at least 7 days prior to the beginning of the study and hot flashes for at least 30 days prior to the beginning of the study
- No chronic migraine headaches, seizure disorders, serious vestibular disorders, or pathological vertigo
- No serious psychiatric disorders
Show all 10Show fewer
- Not pregnant
- No current substance abuse
- Not participating in other forms of therapy
- Not using medical marijuana.
Who cannot join
- women aged 28-55 with breast cancer suffering from hot flashes
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the potential of a unique artificial intelligence-virtual reality intervention called Bubble, to reduce the number and intensity of hot flashes and their accompanying psychological symptoms in women, aged 28-55, with breast cancer. A sample of 37 women with breast cancer were selected to the study. Participants were asked to answer a survey before and after using Bubble. The treatment period was 24 days. The findings are positive and show that the use of Bubble help to reduce several psychological symptoms connected to hot flashes.
Read the detailed description
Breast cancer is the most common cancer in women and the leading cause of death in women aged < 55 years . Hot flashes are experienced by about 52% of perimenopausal women. After breast cancer, this may increase to 70%. Hot flash is a subjective sensation of heat that is associated with objective signs of cutaneous vasodilatation and a subsequent drop in core temperature. The hot flash may be accompanied by physiological symptoms as sweating, flashing, palpitations, and night sweat. As well as by psychological symptoms as anxiety, irritability, and even panic. Hot flashes and night sweats (HF/NS) affect 65-85% of breast cancer survivors and are associated with sleep problems and reduced quality of life.
It is well known that estrogen largely alleviates vasomotor symptoms, however concerns regarding its use in women, with or without breast cancer, has led to extensive research efforts to find well tolerated and efficient nonhormonal interventions. Postmenopausal women and breast cancer survivors experience psychological, spiritual, sleep, and cognitive dysfunction beyond what could be attributable to vasomotor symptoms alone. Therefore, an integrative intervention that can address multiple symptoms is an important patient-centric strategy.
These days a growing body of research has been dedicated to mind-body interventions. These interventions include yoga, hypnosis, relaxation-training/paced respiration, mindfulness-based stress reduction (MBSR), and cognitive behavioral therapy (CBT). In practice, a previous study demonstrated that distressing or problematic hot flashes were predicted by depression, anxiety, and low self-image, but not by the frequency of the hot flashes. Therefore, women with the same amount of hot flashes may have different and diverse emotional responses to their hot flashes. This psychosocial aspect plays a role in the distress or can be related to the symptom as well as to the person's will to do something about his situation. Cognitive behavioral therapy has a long and well documented history of efficacy related to distress, sleep, and psychological aspects of coping with many of life's challenges. A study showed that a brief, mindfulness-based intervention demonstrated preliminary short-term efficacy in reducing stress, behavioral symptoms, and proinflammatory signaling in younger breast cancer survivors. Also, research indicated that relaxation training reduced the incidence and severity of hot flashes and the distress caused by the flashes in women with primary breast cancer compered to control group.
Virtual reality (VR) is a computer technology that uses virtual reality headsets or multi-projected environments, sometimes in combination with physical environments or props, to generate realistic images, sounds and other sensations that simulate a user's physical presence in a virtual or imaginary environment. Today there are two main categories of VR, immersive and non-immersive. Immersion or presence can be regarded as a variable that can influence the effects on the attention of users. Full immersion is reached by a head mounted display, which blocks the users' view of the real world and presents patients with a view of a computer-generated world instead. This technology may offer subjects a safe environment.
A review of 19 studies reporting the use of VR in therapies related to cancer patients showed that four out of eight studies that evaluated bio-physiological outcomes found significant differences in pulse rate, showing lower heart rate in the VR group compared with the non-treatment control group. Furthermore, all studies evaluating the efficacy of VR on different psychological variables found a significant improvement following treatment. In addition, there have been studies of virtual reality in women receiving chemotherapy, older women with breast cancer receiving chemotherapy, adults with breast, colon and lung cancer receiving chemotherapy, and older children receiving chemotherapy. Results of these interventions have been positive, with patients reporting to decreased psychological distress, perception that treatment times were shortened and a belief that treatment with virtual reality was better than chemotherapy alone. Importantly, patients generally did not report cyber sickness (i.e., nausea and discomfort that can last for hours after participating in VR applications) and the VR intervention was easy to implement.
Previous findings in the field of body-mind treatments, and specifically VR as a treatment for women with breast cancer, have led to the current study, which aimed to evaluate the Bubble, a new VR-AI way of treatment specifically tailored for improving symptoms associated with hot flashes in female cancer patients. As previous findings in the field showed the advantages of VR, CBT and mindfulness as treatments for women with cancer or for women who suffer from hot flashes, they are not specific to hot flashes caused by cancer nor not combining the three methods together. In this study we are trying to understand the effect of CBT and mindfulness treatment when given with a VR technology. Specifically, we tried to explore the effect of this combined type of treatment on women who suffer from hot flashes caused by cancer. Furthermore, the current study tries to understand what method work for whom and hence we recruited younger and older women and didn't focused only on one age group.
This pilot study evaluated the potential of a unique artificial intelligence-virtual reality intervention called Bubble, to reduce the number and intensity of hot flashes and their accompanying psychological symptoms in women, aged 28-55, with breast cancer. A repeated measures design was used to answer the following questions: (1) Is AI-VR an effective intervention for reducing hot flashes in women with breast cancer? (2) Is AI-VR intervention decreases the intensity and/or frequency of symptoms associated with hot flashes in women with breast cancer?
Based on past research, as well as our own pilot data collected from focus groups (detailed in the procedure section), we hypothesized that the use of Bubble will lead to an improvement decrease intensity of hot flashes and the psychological symptoms connecting to them (stress, psychopathology level), as well as improve life and sleep quality.
- Conditions
- Hot Flashes, Breast Cancer
- Being tested
- Bubble: A New VR-AI Way of Treatment for Hot Flashes
- Medical subject headings
- Hot Flashes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble: A New VR-AI Way of Treatment for Hot FlashesDevice
Bubble Bubble is a virtual reality (VR) mobile application. Bubble offers a psychological intervention based upon cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) protocols. The bubble mobile application offers the intervention in a virtual reality (VR) coaching environment and in a winter wonderland setting called Frosty. Frosty provides both a virtual reality winter wonderland experience as well as guided meditation. The cold, winter-like experience is designed to help patients calm down and feel cooler.
| Study group | Role | What they receive |
|---|---|---|
| research group | Experimental | Not described Receives: Device: Bubble: A New VR-AI Way of Treatment for Hot Flashes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and background (disease & treatment-elated) information
A form was used to assess demographic information, including birth date, race, education, marital status, employment status, and household income. Women also were asked to record their height and weight, which was used to calculate body mass index. Routine information regarding date of diagnosis, stage of disease, and types and dates of cancer treatments was obtained from medical records
Measured: Through study completion, an average of 1 month
HFRDIS, The Hot Flash Related Daily Interference Scale
The Hot Flash Related Daily Interference Scale (HFRDIS;Carpenter, 2001) is a 10-item scale measuring the degree to which hot flashes interfere with nine daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was developed to include daily life activities specific to the impact of hot flashes. Participants rate the degree to which hot flashes have interfered with each item during the previous week using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.
Measured: Through study completion, an average of 1 month, before the manipulation
HFRDIS, The Hot Flash Related Daily Interference Scale
The Hot Flash Related Daily Interference Scale (HFRDIS;Carpenter, 2001) is a 10-item scale measuring the degree to which hot flashes interfere with nine daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was developed to include daily life activities specific to the impact of hot flashes. Participants rate the degree to which hot flashes have interfered with each item during the previous week using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.
Measured: Through study completion, an average of 1 month, after the manipulation
HFRS, The Hot Flash Rating Scale
measures the frequency and intensity of hot flashes and night sweats per day and per week. It also estimates chronicity and average duration of the hot flashes, as well as provides rating on three separate ten-point scales (1/10 being the least and 10/10 being the most) for the amount of distress, the extent to which HFs interfered with daily life and the degree to which HFs were a problem in patients' lives. A higher score indicates more HF per day.
Measured: Through study completion, an average of 1 month, before the manipulation
HFRS, The Hot Flash Rating Scale
measures the frequency and intensity of hot flashes and night sweats per day and per week. It also estimates chronicity and average duration of the hot flashes, as well as provides rating on three separate ten-point scales (1/10 being the least and 10/10 being the most) for the amount of distress, the extent to which HFs interfered with daily life and the degree to which HFs were a problem in patients' lives. A higher score indicates more HF per day.
Measured: Through study completion, an average of 1 month, after the manipulation
PSS, The Perceived Stress Scale
a self-reported questionnaire that was designed to measure the degree to which situations in one's life over the past week are appraised as unpredictable, uncontrollable and overwhelming. It posits that people appraise potentially-threatening or challenging events in relation to their available coping resources. Items are rated on a Likert scale ranging from 0 (never) to 4 (very often). A higher score indicates a greater degree of perceived stress.
Measured: Through study completion, an average of 1 month, before the manipulation
PSS, The Perceived Stress Scale
a self-reported questionnaire that was designed to measure the degree to which situations in one's life over the past week are appraised as unpredictable, uncontrollable and overwhelming. It posits that people appraise potentially-threatening or challenging events in relation to their available coping resources. Items are rated on a Likert scale ranging from 0 (never) to 4 (very often). A higher score indicates a greater degree of perceived stress.
Measured: Through study completion, an average of 1 month, after the manipulation
K10, The Kessler Psychological Distress Scale
10-item measure of psychological distress in the past month, which reliably predicts the presence of a current depressive or anxiety disorder at a cut-off score of 17. The K10 is a 10-item questionnaire rated on a five-point Likert-type scale (from "none of the time" = 1 to "all of the time" = 5). A higher score indicates a greater degree of distress.
Measured: Through study completion, an average of 1 month, before the manipulation
K10, The Kessler Psychological Distress Scale
10-item measure of psychological distress in the past month, which reliably predicts the presence of a current depressive or anxiety disorder at a cut-off score of 17. The K10 is a 10-item questionnaire rated on a five-point Likert-type scale (from "none of the time" = 1 to "all of the time" = 5). A higher score indicates a greater degree of distress.
Measured: Through study completion, an average of 1 month, after the manipulation
B-IPQ, The Brief Illness Perception Questionnaire
is designed to provide simple and rapid assessment of illness perceptions, using single items on a scale from 1-10 to assess each item including; perceived consequences, timeline (acute vs chronic), amount of perceived personal control, treatment control, identity (symptoms), concern about the illness, coherence of the illness and emotional representation of the illness.
Measured: Through study completion, an average of 1 month, before the manipulation
B-IPQ, The Brief Illness Perception Questionnaire
is designed to provide simple and rapid assessment of illness perceptions, using single items on a scale from 1-10 to assess each item including; perceived consequences, timeline (acute vs chronic), amount of perceived personal control, treatment control, identity (symptoms), concern about the illness, coherence of the illness and emotional representation of the illness.
Measured: Through study completion, an average of 1 month, after the manipulation
PSQI, The Pittsburgh Sleep Quality Index
a retrospective self-report questionnaire that measures sleep quality over the previous month. Seven clinically derived domains of sleep difficulties (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) are assessed. The PSQI global score allowed discriminating between healthy controls and patients, and between groups of patients affected by different pathologies. Results also indicated that the best cut-off score (differentiating "good" from "bad" sleepers) is 5.
Measured: Through study completion, an average of 1 month, before the manipulation
PSQI, The Pittsburgh Sleep Quality Index
a retrospective self-report questionnaire that measures sleep quality over the previous month. Seven clinically derived domains of sleep difficulties (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) are assessed. The PSQI global score allowed discriminating between healthy controls and patients, and between groups of patients affected by different pathologies. Results also indicated that the best cut-off score (differentiating "good" from "bad" sleepers) is 5.
Measured: Through study completion, an average of 1 month, after the manipulation
WHOQOL-BREF, The World Health Organization Quality of Life Scale
assesses individuals' perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The WHOQOL-BREF is a 26-item version of the WHOQOL-100 scale, and as the WHOQOL-100 it includes four domains: physical, psychological, social and environmental QOL and 5-point response scales (5,Very satisfied-1,Very dissatisfied;1,Not at all-5,Extremely; 1,Not at all-5,Completely; and 1,Never-5,Always) and Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
Measured: Through study completion, an average of 1 month, before the manipulation
WHOQOL-BREF, The World Health Organization Quality of Life Scale
assesses individuals' perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The WHOQOL-BREF is a 26-item version of the WHOQOL-100 scale, and as the WHOQOL-100 it includes four domains: physical, psychological, social and environmental QOL and 5-point response scales (5,Very satisfied-1,Very dissatisfied;1,Not at all-5,Extremely; 1,Not at all-5,Completely; and 1,Never-5,Always) and Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
Measured: Through study completion, an average of 1 month, after the manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Feb 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Hematology and Oncology Specialists
- Responsible party
- Principal investigator, Danny Horesh, Bar-Ilan University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414033
- Sponsor's protocol ID
- 22012020
- Status last verified
- Jan 2022
- First submitted
- 15 May 2020
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bubble: A New VR-AI Way of Treatment for Hot Flashes in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT04414033
- Acronym / sponsor ID
- 22012020
- Conditions
- Hot Flashes, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Collaborators
- Hematology and Oncology Specialists
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 4 Jun 2020 (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.
This study evaluates the potential of a unique artificial intelligence-virtual reality intervention called Bubble, to reduce the number and intensity of hot flashes and their accompanying psychological symptoms in women, aged 28-55, with breast cancer. A sample of 37 women with breast cancer were selected to the study. Participants were asked to answer a survey before and after using Bubble. The treatment period was 24 days. The findings are positive and show that the use of Bubble help to reduce several psychological symptoms connected to hot flashes.
Detailed description
Breast cancer is the most common cancer in women and the leading cause of death in women aged < 55 years . Hot flashes are experienced by about 52% of perimenopausal women. After breast cancer, this may increase to 70%. Hot flash is a subjective sensation of heat that is associated with objective signs of cutaneous vasodilatation and a subsequent drop in core temperature. The hot flash may be accompanied by physiological symptoms as sweating, flashing, palpitations, and night sweat. As well as by psychological symptoms as anxiety, irritability, and even panic. Hot flashes and night sweats (HF/NS) affect 65-85% of breast cancer survivors and are associated with sleep problems and reduced quality of life.
It is well known that estrogen largely alleviates vasomotor symptoms, however concerns regarding its use in women, with or without breast cancer, has led to extensive research efforts to find well tolerated and efficient nonhormonal interventions. Postmenopausal women and breast cancer survivors experience psychological, spiritual, sleep, and cognitive dysfunction beyond what could be attributable to vasomotor symptoms alone. Therefore, an integrative intervention that can address multiple symptoms is an important patient-centric strategy.
These days a growing body of research has been dedicated to mind-body interventions. These interventions include yoga, hypnosis, relaxation-training/paced respiration, mindfulness-based stress reduction (MBSR), and cognitive behavioral therapy (CBT). In practice, a previous study demonstrated that distressing or problematic hot flashes were predicted by depression, anxiety, and low self-image, but not by the frequency of the hot flashes. Therefore, women with the same amount of hot flashes may have different and diverse emotional responses to their hot flashes. This psychosocial aspect plays a role in the distress or can be related to the symptom as well as to the person's will to do something about his situation. Cognitive behavioral therapy has a long and well documented history of efficacy related to distress, sleep, and psychological aspects of coping with many of life's challenges. A study showed that a brief, mindfulness-based intervention demonstrated preliminary short-term efficacy in reducing stress, behavioral symptoms, and proinflammatory signaling in younger breast cancer survivors. Also, research indicated that relaxation training reduced the incidence and severity of hot flashes and the distress caused by the flashes in women with primary breast cancer compered to control group.
Virtual reality (VR) is a computer technology that uses virtual reality headsets or multi-projected environments, sometimes in combination with physical environments or props, to generate realistic images, sounds and other sensations that simulate a user's physical presence in a virtual or imaginary environment. Today there are two main categories of VR, immersive and non-immersive. Immersion or presence can be regarded as a variable that can influence the effects on the attention of users. Full immersion is reached by a head mounted display, which blocks the users' view of the real world and presents patients with a view of a computer-generated world instead. This technology may offer subjects a safe environment.
A review of 19 studies reporting the use of VR in therapies related to cancer patients showed that four out of eight studies that evaluated bio-physiological outcomes found significant differences in pulse rate, showing lower heart rate in the VR group compared with the non-treatment control group. Furthermore, all studies evaluating the efficacy of VR on different psychological variables found a significant improvement following treatment. In addition, there have been studies of virtual reality in women receiving chemotherapy, older women with breast cancer receiving chemotherapy, adults with breast, colon and lung cancer receiving chemotherapy, and older children receiving chemotherapy. Results of these interventions have been positive, with patients reporting to decreased psychological distress, perception that treatment times were shortened and a belief that treatment with virtual reality was better than chemotherapy alone. Importantly, patients generally did not report cyber sickness (i.e., nausea and discomfort that can last for hours after participating in VR applications) and the VR intervention was easy to implement.
Previous findings in the field of body-mind treatments, and specifically VR as a treatment for women with breast cancer, have led to the current study, which aimed to evaluate the Bubble, a new VR-AI way of treatment specifically tailored for improving symptoms associated with hot flashes in female cancer patients. As previous findings in the field showed the advantages of VR, CBT and mindfulness as treatments for women with cancer or for women who suffer from hot flashes, they are not specific to hot flashes caused by cancer nor not combining the three methods together. In this study we are trying to understand the effect of CBT and mindfulness treatment when given with a VR technology. Specifically, we tried to explore the effect of this combined type of treatment on women who suffer from hot flashes caused by cancer. Furthermore, the current study tries to understand what method work for whom and hence we recruited younger and older women and didn't focused only on one age group.
This pilot study evaluated the potential of a unique artificial intelligence-virtual reality intervention called Bubble, to reduce the number and intensity of hot flashes and their accompanying psychological symptoms in women, aged 28-55, with breast cancer. A repeated measures design was used to answer the following questions: (1) Is AI-VR an effective intervention for reducing hot flashes in women with breast cancer? (2) Is AI-VR intervention decreases the intensity and/or frequency of symptoms associated with hot flashes in women with breast cancer?
Based on past research, as well as our own pilot data collected from focus groups (detailed in the procedure section), we hypothesized that the use of Bubble will lead to an improvement decrease intensity of hot flashes and the psychological symptoms connecting to them (stress, psychopathology level), as well as improve life and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research group | Experimental | Device: Bubble: A New VR-AI Way of Treatment for Hot Flashes |
Who may qualify
- Ages
- 28 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Females between the ages of 18 and 60
- Having an existing diagnosis of breast or ovarian cancer
- Receiving standard-of-care chemotherapy, endocrine therapy or estrogen blocking anti-cancer treatment
- The woman reported experiencing hot flashes at least once per day for a duration of at least 7 days prior to the beginning of the study and hot flashes for at least 30 days prior to the beginning of the study
- No chronic migraine headaches, seizure disorders, serious vestibular disorders, or pathological vertigo
Key exclusion criteria (1 listed)
- women aged 28-55 with breast cancer suffering from hot flashes
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 |
|---|---|---|
| Bubble: A New VR-AI Way of Treatment for Hot FlashesBubble Bubble is a virtual reality (VR) mobile application. Bubble offers a psychological intervention based upon cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) protocols. The bubble mobile application offers the intervention in a virtual reality (VR) coaching environment and in a winter wonderland setting called Frosty. Frosty provides both a virtual reality winter wonderland experience as well as guided meditation. The cold, winter-like experience is designed to help patients calm down and feel cooler. | Device | research group |
Primary outcome
Demographic and background (disease & treatment-elated) information
Time frame: Through study completion, an average of 1 month
A form was used to assess demographic information, including birth date, race, education, marital status, employment status, and household income. Women also were asked to record their height and weight, which was used to calculate body mass index. Routine information regarding date of diagnosis, stage of disease, and types and dates of cancer treatments was obtained from medical records
HFRDIS, The Hot Flash Related Daily Interference Scale
Time frame: Through study completion, an average of 1 month, before the manipulation
The Hot Flash Related Daily Interference Scale (HFRDIS;Carpenter, 2001) is a 10-item scale measuring the degree to which hot flashes interfere with nine daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was developed to include daily life activities specific to the impact of hot flashes. Participants rate the degree to which hot flashes have interfered with each item during the previous week using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.
HFRDIS, The Hot Flash Related Daily Interference Scale
Time frame: Through study completion, an average of 1 month, after the manipulation
The Hot Flash Related Daily Interference Scale (HFRDIS;Carpenter, 2001) is a 10-item scale measuring the degree to which hot flashes interfere with nine daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was developed to include daily life activities specific to the impact of hot flashes. Participants rate the degree to which hot flashes have interfered with each item during the previous week using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.
HFRS, The Hot Flash Rating Scale
Time frame: Through study completion, an average of 1 month, before the manipulation
measures the frequency and intensity of hot flashes and night sweats per day and per week. It also estimates chronicity and average duration of the hot flashes, as well as provides rating on three separate ten-point scales (1/10 being the least and 10/10 being the most) for the amount of distress, the extent to which HFs interfered with daily life and the degree to which HFs were a problem in patients' lives. A higher score indicates more HF per day.
HFRS, The Hot Flash Rating Scale
Time frame: Through study completion, an average of 1 month, after the manipulation
measures the frequency and intensity of hot flashes and night sweats per day and per week. It also estimates chronicity and average duration of the hot flashes, as well as provides rating on three separate ten-point scales (1/10 being the least and 10/10 being the most) for the amount of distress, the extent to which HFs interfered with daily life and the degree to which HFs were a problem in patients' lives. A higher score indicates more HF per day.
PSS, The Perceived Stress Scale
Time frame: Through study completion, an average of 1 month, before the manipulation
a self-reported questionnaire that was designed to measure the degree to which situations in one's life over the past week are appraised as unpredictable, uncontrollable and overwhelming. It posits that people appraise potentially-threatening or challenging events in relation to their available coping resources. Items are rated on a Likert scale ranging from 0 (never) to 4 (very often). A higher score indicates a greater degree of perceived stress.
PSS, The Perceived Stress Scale
Time frame: Through study completion, an average of 1 month, after the manipulation
a self-reported questionnaire that was designed to measure the degree to which situations in one's life over the past week are appraised as unpredictable, uncontrollable and overwhelming. It posits that people appraise potentially-threatening or challenging events in relation to their available coping resources. Items are rated on a Likert scale ranging from 0 (never) to 4 (very often). A higher score indicates a greater degree of perceived stress.
K10, The Kessler Psychological Distress Scale
Time frame: Through study completion, an average of 1 month, before the manipulation
10-item measure of psychological distress in the past month, which reliably predicts the presence of a current depressive or anxiety disorder at a cut-off score of 17. The K10 is a 10-item questionnaire rated on a five-point Likert-type scale (from "none of the time" = 1 to "all of the time" = 5). A higher score indicates a greater degree of distress.
K10, The Kessler Psychological Distress Scale
Time frame: Through study completion, an average of 1 month, after the manipulation
10-item measure of psychological distress in the past month, which reliably predicts the presence of a current depressive or anxiety disorder at a cut-off score of 17. The K10 is a 10-item questionnaire rated on a five-point Likert-type scale (from "none of the time" = 1 to "all of the time" = 5). A higher score indicates a greater degree of distress.
B-IPQ, The Brief Illness Perception Questionnaire
Time frame: Through study completion, an average of 1 month, before the manipulation
is designed to provide simple and rapid assessment of illness perceptions, using single items on a scale from 1-10 to assess each item including; perceived consequences, timeline (acute vs chronic), amount of perceived personal control, treatment control, identity (symptoms), concern about the illness, coherence of the illness and emotional representation of the illness.
B-IPQ, The Brief Illness Perception Questionnaire
Time frame: Through study completion, an average of 1 month, after the manipulation
is designed to provide simple and rapid assessment of illness perceptions, using single items on a scale from 1-10 to assess each item including; perceived consequences, timeline (acute vs chronic), amount of perceived personal control, treatment control, identity (symptoms), concern about the illness, coherence of the illness and emotional representation of the illness.
PSQI, The Pittsburgh Sleep Quality Index
Time frame: Through study completion, an average of 1 month, before the manipulation
a retrospective self-report questionnaire that measures sleep quality over the previous month. Seven clinically derived domains of sleep difficulties (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) are assessed. The PSQI global score allowed discriminating between healthy controls and patients, and between groups of patients affected by different pathologies. Results also indicated that the best cut-off score (differentiating "good" from "bad" sleepers) is 5.
PSQI, The Pittsburgh Sleep Quality Index
Time frame: Through study completion, an average of 1 month, after the manipulation
a retrospective self-report questionnaire that measures sleep quality over the previous month. Seven clinically derived domains of sleep difficulties (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) are assessed. The PSQI global score allowed discriminating between healthy controls and patients, and between groups of patients affected by different pathologies. Results also indicated that the best cut-off score (differentiating "good" from "bad" sleepers) is 5.
WHOQOL-BREF, The World Health Organization Quality of Life Scale
Time frame: Through study completion, an average of 1 month, before the manipulation
assesses individuals' perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The WHOQOL-BREF is a 26-item version of the WHOQOL-100 scale, and as the WHOQOL-100 it includes four domains: physical, psychological, social and environmental QOL and 5-point response scales (5,Very satisfied-1,Very dissatisfied;1,Not at all-5,Extremely; 1,Not at all-5,Completely; and 1,Never-5,Always) and Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
WHOQOL-BREF, The World Health Organization Quality of Life Scale
Time frame: Through study completion, an average of 1 month, after the manipulation
assesses individuals' perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The WHOQOL-BREF is a 26-item version of the WHOQOL-100 scale, and as the WHOQOL-100 it includes four domains: physical, psychological, social and environmental QOL and 5-point response scales (5,Very satisfied-1,Very dissatisfied;1,Not at all-5,Extremely; 1,Not at all-5,Completely; and 1,Never-5,Always) and Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
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 27 Jan 2022.
- Andrews, G., \& Slade, T. (2001). Interpreting scores on the Kessler Psychological Distress Scale (K10). Australian and New Zealand Journal of Public Health, 25(6), 494-497.Link provided by the sponsor.
- Blumel, J. E., Castelo-Branco, C., Binfa, L., Gramegna, G., Tacla, X., Aracena, B., … Sanjuan, A. (2000). Quality of life after the menopause: A population study. Maturitas, 34(1), 17-23.Link provided by the sponsor.
- Buysse, D. J., Reynolds, C. F., Monk, T. H., Berman, S. R., \& Kupfer, D. J. (1989). The Pittsburgh sleep quality index: A new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193-213Link provided by the sponsor.
- Fenlon, D. R., Corner, J. L., \& Haviland, J. S. (2008). A Randomized Controlled Trial of Relaxation Training to Reduce Hot Flashes in Women with Primary Breast Cancer. Journal of Pain and Symptom Management, 35(4), 397-405Link provided by the sponsor.
- Hardy, C. (2017). The Hot Flash Related Daily Interference Scale: Cutoffs, minimally important differences, and a revised short version. Menopause, 24(8), 869-870.Link provided by the sponsor.
- Kadakia, K. C., Loprinzi, C. L., \& Barton, D. L. (2012). Hot flashes: The ongoing search for effective interventions. Menopause: The Journal of The North American Menopause Society, 19(7), 719-721.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bubble: A New VR-AI Way of Treatment for Hot Flashes in people with Hot Flashes and Breast Cancer, run by Bar-Ilan University, Israel at 1 site in Israel.
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 10 inclusion and 1 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 27 Jan 2022. 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 Israel. 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?
Demographic and background (disease & treatment-elated) information (time frame: Through study completion, an average of 1 month). The study lists 15 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 27 Jan 2022.