Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-01 @ 3:47 PM
Study NCT ID:
NCT07023692
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-17
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual and Auditory Distraction for the Relief of Pain and Anxiety
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
Visual and Auditory Distraction for the Relief of Pain and Anxiety
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bone marrow (BM) examinations are performed in diagnostic workup of malignancies, in particular hematological diseases, and are frequently associated with significant pain, distress, and anxiety. Analgesic and sedative medications are given to alleviate discomfort.
The aim of this project is to study the effects of visual and auditory distraction on pain and anxiety during BM examinations.
The project includes two baseline studies assessing pain perception, anxiety, and nociceptive response in patients and healthy volunteers undergoing BM examinations, and two randomized controlled trials evaluating the efficacy of VR distraction in reducing pain perception, anxiety, and nociceptive response. The intervention groups will use VR headsets, while control groups will follow standard procedure. Data collection include measurements of skin conductance, pulse, validated questionnaires and qualitative interviews.
The project is strongly anchored in clinical practices and is a collaboration between Skåne University Hospital and Lund University, Sweden. The project group consists of three experts with relevant clinical and research competences. The project is ongoing, data collection will be finalized in 2028, and analyses and publications in 2027-2029.
If distraction with VR results in less painful examinations and shows to be feasible in clinical praxis, the findings may contribute to development of new guidelines for pain management in BM-examinations and other painful medical procedures.
The aim of this project is to study the effects of visual and auditory distraction on pain and anxiety during BM examinations.
The project includes two baseline studies assessing pain perception, anxiety, and nociceptive response in patients and healthy volunteers undergoing BM examinations, and two randomized controlled trials evaluating the efficacy of VR distraction in reducing pain perception, anxiety, and nociceptive response. The intervention groups will use VR headsets, while control groups will follow standard procedure. Data collection include measurements of skin conductance, pulse, validated questionnaires and qualitative interviews.
The project is strongly anchored in clinical practices and is a collaboration between Skåne University Hospital and Lund University, Sweden. The project group consists of three experts with relevant clinical and research competences. The project is ongoing, data collection will be finalized in 2028, and analyses and publications in 2027-2029.
If distraction with VR results in less painful examinations and shows to be feasible in clinical praxis, the findings may contribute to development of new guidelines for pain management in BM-examinations and other painful medical procedures.
Detailed Description:
Purpose and aims: The overall aim of this project is to study the effect of visual and auditory distraction as a relief for pain and anxiety in adults undergoing bone marrow aspiration and/or biopsy. The goal is to increase knowledge about pain and pain relief during bone marrow procedures, as well as to explore whether there is a difference in pain responses and experiences of health, anxiety, and pain between patients and healthy volunteers. Additionally, the project aims to investigate whether individuals undergoing bone marrow examinations can experience less anxiety and pain compared to standard procedures through visual and auditory distraction via VR, and whether pain relief can be made more individualized and person centered.
Specific objectives:
To evaluate if it is possible to measure anxiety-induced stress responses and pain in individuals undergoing bone marrow examinations during standard procedures with objective measurement tools (skin conductance and pulse).
To evaluate how individuals rate their health, anxiety, and pain after a bone marrow examination.
To evaluate if there is a difference in anxiety-induced stress responses and pain between patients and healthy volunteers undergoing bone marrow examinations with VR versus without VR.
To evaluate if there is a difference in self-reported health, anxiety, and pain between patients and healthy volunteers undergoing bone marrow examinations with VR versus without VR.
To evaluate if there is a difference in patients' and healthy volunteers' experiences of a bone marrow examination with VR versus without VR.
To evaluate if there is a difference in the dosage of local anesthetics and any sedative medications used during a bone marrow examination with VR versus without VR.
To evaluate the staff's perceptions of the approach to bone marrow examinations with VR versus without VR.
State-of-the art: Bone marrow examinations are conducted for the diagnosis and follow-up of various hematological diseases and treatments. The purpose is to search for, confirm, or exclude a hematological diagnosis, or to evaluate the effectiveness of treatment for an already established disease. The majority of patients with hematological diseases typically undergo several bone marrow examinations during their disease and treatment periods.
Bone marrow samples are typically taken from the back of the hip bone. To optimize the placement of the sampling site, the patient is usually positioned on their side with knees drawn up and bent. Local anesthesia is commonly used for adults undergoing bone marrow examinations, while general anesthesia is rarely used, whereas it is routine for children (\<18 years old). The bone marrow sample is taken using a relatively large needle that is inserted through the skin and approximately half a centimeter into the hip bone, where a small amount of bone marrow is aspirated, alternatively, a tissue sample of the bone marrow is taken. Bone marrow examinations usually take about 15-20 minutes.
For the patient, bone marrow examinations are often perceived as a painful and uncomfortable experience, and are therefore frequently associated with anxiety, which is often related to concerns about the results of the examination. Various pain relief regimens are used, with Lidocaine-based local anesthesia being the most common. However, there are no clear guidelines regarding the anesthesia procedure for bone marrow examinations.
A few studies have been conducted to investigate the effect of VR headsets as a form of reality diversion on pain and anxiety during bone marrow examinations, which indicate that VR headsets are well-tolerated and that patients, nurses, and physicians report satisfaction. However, the effect of VR headsets on pain intensity has shown varying results, suggesting that more studies are needed. In previous studies, pain and anxiety have been measured using self-report tools, but without objective measurements of pain.
Objective measurements of pain response (nociception) are currently available both in research and commercially through a variety of techniques. One of the most common and well-studied methods is the Nociception Level Index (NOL) from Medasense, which uses a fingertip sensor to measure physiological values and then presents the degree of nociception numerically. Additionally, the PainSensor from MedStorm (PAM), a sensor attached to the palm of the hand, measures changes in the skin's ability to conduct electrical signals (skin conductance) and provides a nociception value based on this.
Using VR headsets means that the patient wears glasses and headphones that place them in a virtual reality while still being able to communicate with the responsible staff. The examination can thus be tailored to the individual as well as designed in a way that hopefully provides the patient with enhanced experience and better pain relief outcomes. Currently, VR is not routinely used as a distraction during bone marrow examinations. The goal is that this research project will lead to increased patient satisfaction regarding perceived pain and anxiety, as well as involvement in decision-making about pain relief methods, and that additional knowledge about the procedure will be gained.
Significance and scientific novelty: The use of VR for distraction is rare in clinical practice. The originality of this project primarily lies in its strong clinical foundation, which allows for direct implementation of the results into clinical practice. This could potentially benefit patients in the near future after the project's conclusion. The project is rooted in clinical practice, utilizing VR in conjunction with bone marrow examinations. Bone marrow examinations are necessary and recurring for patients with hematological diagnoses, most often cancer, for the selection of further treatments, and are crucial for the patient's diagnosis, disease status, and prognosis. Having a hematological diagnosis means undergoing multiple treatments over an extended period, which involves many hospitalizations with demanding treatments, discomfort, illness, and pain. Distraction with VR could make these examinations feel less stressful, potentially making the patient's pain more tolerable and reducing time spent in the hospital during the examinations, as well reducing the use of opioids and their troublesome side effects.
Preliminary and previous results: The development phase of the project, including a Proof of Concept (POC) study, was conducted in the spring of 2024. The concept was tested on eight patients who underwent bone marrow examinations according to the standard procedure, all of whom had prior experience with this examination, and demonstrated good feasibility. At the end of the autumn of 2024, the project started with the first study, which involves measuring nociceptive responses using conductance monitoring and pulse during bone marrow examinations according to the standard procedure, as well as administering questionnaires to patients and staff after the examination.
Project description, Theory and method:
The project is designed as a complex intervention study and consists of four studies: two observational studies (baseline) with patients (Study 1) and healthy volunteers (Study 2) undergoing bone marrow examination according to the standard procedure, and two randomized intervention studies with patients (Study 3) and healthy volunteers (Study 4) undergoing bone marrow examination in two arms:
The intervention group: Distraction with VR headsets during bone marrow examinations The control group: Bone marrow examinations according to standard procedure
The total number of participants expected to be included is approximately 220 patients and 40-80 healthy volunteers:
Data collection:
During the ongoing bone marrow examination: In all four studies, objective markers measuring the level of pain (nociception) will be studied. Nociceptive response will be monitored using the two techniques NOL and MedStorm PainSensor, as well as pulse recordings using an additional finger clamp.
Immediately after the bone marrow examination:
In all four studies, questionnaires will be given to the study participants (patients and healthy volunteers) with questions regarding demographics (age and gender), the number of previous bone marrow examinations, and any ongoing pain and/or anxiety issues, including the location of any pain. Additionally, validated self-reported instruments will be used.
Individual interviews with approximately 20 patients (Study 3) and around 10 healthy volunteers (Study 4) will be conducted to gain deeper insight into their experiences with the use of VR headsets, their sense of involvement, pain, and anxiety. Individual interviews will also be carried out with about 10 staff members who have been involved in bone marrow examinations where VR headsets were used, to gather in-depth knowledge about their experiences.
Time plan and implementation:
Ethical approval from the Ethics Review Authority (EPM) was obtained on June 17, 2024, Dnr 2024-02133-01.
Proof of Concept (POC) was conducted in the spring of 2024, which demonstrated good feasibility.
The project was planned and initiated in the fall of 2024. The inclusion and implementation of Study 1 began toward the end of 2024 and is ongoing, with completion expected in June 2026. Study 2 is being conducted in parallel.
Data analysis from Studies 1 and 2 are scheduled for the fall of 2026, with results expected to be ready for publication in 2027.
Studies 3 and 4 are planned to take place in 2027 - 2028, with analysis in 2028 and publication ready by 2029.
The project is expected to conclude in 2029, with clinical implementation planned post-2029, including the dissemination of the intervention to other centers conducting bone marrow biopsies.
Project organization:
The project is carried out in collaboration between the Department of Hematology, Oncology, and Radiation Physics at Skåne University Hospital (SUS) and the Department of Health Sciences (IHV), Faculty of Medicine, Lund University (LU). The project group consists of experts with relevant clinical and research competencies. The members of the project group have extensive experience working with all the scientific approaches involved in the project, ensuring the execution and credibility of the results.
Baseline studies are ongoing. Power analysis will be performed in a post baseline using the Power and Sample Size Program prior to the intervention study. However, previous literature indicates that the number of patients for a randomized study should be at least n = 100. Regarding the risk of non-response, we should increase the number of people included in the study by 10%, which means including a total of 110 study patients, 55 per group: intervention and control.
Specific objectives:
To evaluate if it is possible to measure anxiety-induced stress responses and pain in individuals undergoing bone marrow examinations during standard procedures with objective measurement tools (skin conductance and pulse).
To evaluate how individuals rate their health, anxiety, and pain after a bone marrow examination.
To evaluate if there is a difference in anxiety-induced stress responses and pain between patients and healthy volunteers undergoing bone marrow examinations with VR versus without VR.
To evaluate if there is a difference in self-reported health, anxiety, and pain between patients and healthy volunteers undergoing bone marrow examinations with VR versus without VR.
To evaluate if there is a difference in patients' and healthy volunteers' experiences of a bone marrow examination with VR versus without VR.
To evaluate if there is a difference in the dosage of local anesthetics and any sedative medications used during a bone marrow examination with VR versus without VR.
To evaluate the staff's perceptions of the approach to bone marrow examinations with VR versus without VR.
State-of-the art: Bone marrow examinations are conducted for the diagnosis and follow-up of various hematological diseases and treatments. The purpose is to search for, confirm, or exclude a hematological diagnosis, or to evaluate the effectiveness of treatment for an already established disease. The majority of patients with hematological diseases typically undergo several bone marrow examinations during their disease and treatment periods.
Bone marrow samples are typically taken from the back of the hip bone. To optimize the placement of the sampling site, the patient is usually positioned on their side with knees drawn up and bent. Local anesthesia is commonly used for adults undergoing bone marrow examinations, while general anesthesia is rarely used, whereas it is routine for children (\<18 years old). The bone marrow sample is taken using a relatively large needle that is inserted through the skin and approximately half a centimeter into the hip bone, where a small amount of bone marrow is aspirated, alternatively, a tissue sample of the bone marrow is taken. Bone marrow examinations usually take about 15-20 minutes.
For the patient, bone marrow examinations are often perceived as a painful and uncomfortable experience, and are therefore frequently associated with anxiety, which is often related to concerns about the results of the examination. Various pain relief regimens are used, with Lidocaine-based local anesthesia being the most common. However, there are no clear guidelines regarding the anesthesia procedure for bone marrow examinations.
A few studies have been conducted to investigate the effect of VR headsets as a form of reality diversion on pain and anxiety during bone marrow examinations, which indicate that VR headsets are well-tolerated and that patients, nurses, and physicians report satisfaction. However, the effect of VR headsets on pain intensity has shown varying results, suggesting that more studies are needed. In previous studies, pain and anxiety have been measured using self-report tools, but without objective measurements of pain.
Objective measurements of pain response (nociception) are currently available both in research and commercially through a variety of techniques. One of the most common and well-studied methods is the Nociception Level Index (NOL) from Medasense, which uses a fingertip sensor to measure physiological values and then presents the degree of nociception numerically. Additionally, the PainSensor from MedStorm (PAM), a sensor attached to the palm of the hand, measures changes in the skin's ability to conduct electrical signals (skin conductance) and provides a nociception value based on this.
Using VR headsets means that the patient wears glasses and headphones that place them in a virtual reality while still being able to communicate with the responsible staff. The examination can thus be tailored to the individual as well as designed in a way that hopefully provides the patient with enhanced experience and better pain relief outcomes. Currently, VR is not routinely used as a distraction during bone marrow examinations. The goal is that this research project will lead to increased patient satisfaction regarding perceived pain and anxiety, as well as involvement in decision-making about pain relief methods, and that additional knowledge about the procedure will be gained.
Significance and scientific novelty: The use of VR for distraction is rare in clinical practice. The originality of this project primarily lies in its strong clinical foundation, which allows for direct implementation of the results into clinical practice. This could potentially benefit patients in the near future after the project's conclusion. The project is rooted in clinical practice, utilizing VR in conjunction with bone marrow examinations. Bone marrow examinations are necessary and recurring for patients with hematological diagnoses, most often cancer, for the selection of further treatments, and are crucial for the patient's diagnosis, disease status, and prognosis. Having a hematological diagnosis means undergoing multiple treatments over an extended period, which involves many hospitalizations with demanding treatments, discomfort, illness, and pain. Distraction with VR could make these examinations feel less stressful, potentially making the patient's pain more tolerable and reducing time spent in the hospital during the examinations, as well reducing the use of opioids and their troublesome side effects.
Preliminary and previous results: The development phase of the project, including a Proof of Concept (POC) study, was conducted in the spring of 2024. The concept was tested on eight patients who underwent bone marrow examinations according to the standard procedure, all of whom had prior experience with this examination, and demonstrated good feasibility. At the end of the autumn of 2024, the project started with the first study, which involves measuring nociceptive responses using conductance monitoring and pulse during bone marrow examinations according to the standard procedure, as well as administering questionnaires to patients and staff after the examination.
Project description, Theory and method:
The project is designed as a complex intervention study and consists of four studies: two observational studies (baseline) with patients (Study 1) and healthy volunteers (Study 2) undergoing bone marrow examination according to the standard procedure, and two randomized intervention studies with patients (Study 3) and healthy volunteers (Study 4) undergoing bone marrow examination in two arms:
The intervention group: Distraction with VR headsets during bone marrow examinations The control group: Bone marrow examinations according to standard procedure
The total number of participants expected to be included is approximately 220 patients and 40-80 healthy volunteers:
Data collection:
During the ongoing bone marrow examination: In all four studies, objective markers measuring the level of pain (nociception) will be studied. Nociceptive response will be monitored using the two techniques NOL and MedStorm PainSensor, as well as pulse recordings using an additional finger clamp.
Immediately after the bone marrow examination:
In all four studies, questionnaires will be given to the study participants (patients and healthy volunteers) with questions regarding demographics (age and gender), the number of previous bone marrow examinations, and any ongoing pain and/or anxiety issues, including the location of any pain. Additionally, validated self-reported instruments will be used.
Individual interviews with approximately 20 patients (Study 3) and around 10 healthy volunteers (Study 4) will be conducted to gain deeper insight into their experiences with the use of VR headsets, their sense of involvement, pain, and anxiety. Individual interviews will also be carried out with about 10 staff members who have been involved in bone marrow examinations where VR headsets were used, to gather in-depth knowledge about their experiences.
Time plan and implementation:
Ethical approval from the Ethics Review Authority (EPM) was obtained on June 17, 2024, Dnr 2024-02133-01.
Proof of Concept (POC) was conducted in the spring of 2024, which demonstrated good feasibility.
The project was planned and initiated in the fall of 2024. The inclusion and implementation of Study 1 began toward the end of 2024 and is ongoing, with completion expected in June 2026. Study 2 is being conducted in parallel.
Data analysis from Studies 1 and 2 are scheduled for the fall of 2026, with results expected to be ready for publication in 2027.
Studies 3 and 4 are planned to take place in 2027 - 2028, with analysis in 2028 and publication ready by 2029.
The project is expected to conclude in 2029, with clinical implementation planned post-2029, including the dissemination of the intervention to other centers conducting bone marrow biopsies.
Project organization:
The project is carried out in collaboration between the Department of Hematology, Oncology, and Radiation Physics at Skåne University Hospital (SUS) and the Department of Health Sciences (IHV), Faculty of Medicine, Lund University (LU). The project group consists of experts with relevant clinical and research competencies. The members of the project group have extensive experience working with all the scientific approaches involved in the project, ensuring the execution and credibility of the results.
Baseline studies are ongoing. Power analysis will be performed in a post baseline using the Power and Sample Size Program prior to the intervention study. However, previous literature indicates that the number of patients for a randomized study should be at least n = 100. Regarding the risk of non-response, we should increase the number of people included in the study by 10%, which means including a total of 110 study patients, 55 per group: intervention and control.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: