Bone Marrow AspirationNCT07023692
Visual and Auditory Distraction for the Relief of Pain and Anxiety
A study testing Distraction with VR (Virtual Reality) headsets in people with Bone Marrow Aspiration and Pain, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Marrow Aspiration, Pain, Anxiety
- What is being tested?
- Distraction with VR (Virtual Reality) headsets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 20 Oct 2024to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (≥18 years) patients
- Adult (≥18 years) healthy volunteers without a hematological diagnosis undergoing bone marrow examination (aspiration and/or biopsy) at the Hematology Out-Patient Care Unit at SUS in Lund, Sweden.
Who cannot join
- Individuals who cannot understand information and instructions
- Pregnant women
- Persons with skin injuries at the bone marrow examination site
- Those unable to lie on their side
- hearing and/or severe vision impairment
- those prone to motion sickness
- participation in the study during a previous bone marrow examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Hematology Out-Patient Care Unit , Department of hematology, oncology and radian physics, Skåne University Hospital (SUS) in Lund, Sweden
Lund, Skåne County, Se-221 85
About this study
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.
Read more
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.
Read the 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 1) will be conducted to gain a deeper understanding of patients' experiences of undergoing bone marrow examinations as part of standard practice. 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.
- Conditions
- Bone Marrow Aspiration, Pain, Anxiety, Hematologic Diseases, Hematologic Disorders, Visual Distraction
- Being tested
- Distraction with VR (Virtual Reality) headsets
- Keywords
- pain perception, anxiety, nociceptive response, relief of pain, relief of anxiety, visual distraction, auditory distraction
- Medical subject headings
- Pain, Anxiety Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction with VR (Virtual Reality) headsetsBehavioural
VR headsets will be fitted and applied in consultation with the study participants. Distraction material will be selected from a range of options based on the participant's preferences, such as watching/listening to a story, an experience of being in nature, or mindfulness. When applying the VR headsets, care will be taken to ensure no light leaks into the eyes and that the headband and headphones are not perceived as too tight. This is especially important in terms of the risk for motion sickness (cyber sickness). The VR headsets will then be used throughout the examination procedure and removed once the bandage has been applied.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Distraction with VR headsets during bone marrow examinations Receives: Behavioral: Distraction with VR (Virtual Reality) headsets |
| Control group | No intervention | Bone marrow examinations according to standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nociceptive response
Objective markers measuring the level of pain, nociceptive response, monitored by using the the NOL technique, which presents an indexed value between 0 and 100 (i.e. units on a scale), where a higher score means worse outcome, i.e., higher nociceptive response.
Measured: Periprocedural
Nociceptive response
Objective markers measuring the level of pain, nociceptive response, monitored by using the the MedStorm PainSensor technique, which presents an indexed value between 0 and 10 (i.e. units on a scale), where a higher score means worse outcome, i.e., higher nociceptive response.
Measured: Periprocedural
Self-reported subjective health
Questionnaires will be given to the study participants with validated self-reported instrument Perceived Health: RAND-36 - RAND Corporation (Research and Development), reporting a score, 0 - 100 points on a scale, where a higher score means better outcome, i.e. the better health.
Measured: Immediately after the bone marrow examination - Periprocedural
Self-reported subjective pain
Questionnaires will be given to the study participants with the validated self-reported instrument Self-reported Pain: NRS - Numerical Rating Scale, where pain is indicated on a scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
Measured: Immediately after the bone marrow examination - Periprocedural
Self-reported subjective anxiety
Questionnaires will be given to the study participants with the validated self-reported instrument Self-reported Anxiety: STAI - State-Trait Anxiety Inventory. A score will be reported on a scale, where the scores range between 20-80 points, where a higher score means worse outcome, i.e., higher scores indicating higher levels of anxiety.
Measured: Immediately after the bone marrow examination - Periprocedural
Secondary outcomes (1)
Heart rate
Pulse recordings using an additional finger clamp
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start20 Oct 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow AspirationStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023692
- Sponsor's protocol ID
- 2024-02133-01
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) is not of any value to be shared since the focus is to gather data on a group level.
Publications
Jildenstal P, H.K., Almskog K, et al., Monitoring the Nociception Level Intraoperatively - An Initial Experiences. J Anest & Inten Care, 2018. Med. 7(2): p. 555709.
Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.
PubMed 18352969Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089.
PubMed 11491194Karsh BT. Beyond usability: designing effective technology implementation systems to promote patient safety. Qual Saf Health Care. 2004 Oct;13(5):388-94. doi: 10.1136/qhc.13.5.388.
PubMed 15465944Rycroft-Malone J. The PARIHS framework--a framework for guiding the implementation of evidence-based practice. J Nurs Care Qual. 2004 Oct-Dec;19(4):297-304. doi: 10.1097/00001786-200410000-00002. No abstract available.
PubMed 15535533Norbeck DW, Lindgren S, Wolf A, Jildenstal P. Reliability of nociceptive monitors vs. standard practice during general anesthesia: a prospective observational study. BMC Anesthesiol. 2025 Jan 31;25(1):51. doi: 10.1186/s12871-025-02923-4.
PubMed 39891061Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
PubMed 27171828Spielberger CD, Vagg PR. Psychometric properties of the STAI: a reply to Ramanaiah, Franzen, and Schill. J Pers Assess. 1984 Feb;48(1):95-7. doi: 10.1207/s15327752jpa4801_16. No abstract available.
PubMed 6707862Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain. 1997 Aug;72(1-2):95-7. doi: 10.1016/s0304-3959(97)00005-5.
PubMed 9272792Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.
PubMed 18487245Hoffman HG, Richards TL, Van Oostrom T, Coda BA, Jensen MP, Blough DK, Sharar SR. The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments. Anesth Analg. 2007 Dec;105(6):1776-83, table of contents. doi: 10.1213/01.ane.0000270205.45146.db.
PubMed 18042882Soret L, Gendron N, Rivet N, Chocron R, Macraigne L, Clausse D, Cholley B, Gaussem P, Smadja DM, Darnige L. Pain Assessment Using Virtual Reality Facemask During Bone Marrow Aspiration: Prospective Study Including Propensity-Matched Analysis. JMIR Serious Games. 2022 Oct 12;10(4):e33221. doi: 10.2196/33221.
PubMed 36222814Le Du K, Septans AL, Maloisel F, Vanquaethem H, Schmitt A, Le Goff M, Clavert A, Zinger M, Bourgeois H, Dupuis O, Denis F, Bouchard S. A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study. J Med Internet Res. 2023 Feb 15;25:e38619. doi: 10.2196/38619.
PubMed 36790852Korkmaz E, Guler S. The Effect of Video Streaming With Virtual Reality on Anxiety and Pain During Bone Marrow Aspiration and Biopsy Procedure. Pain Manag Nurs. 2023 Dec;24(6):634-640. doi: 10.1016/j.pmn.2023.04.014. Epub 2023 May 27.
PubMed 37246094Boland JW. Effect of Opioids on Survival in Patients with Cancer. Cancers (Basel). 2022 Nov 21;14(22):5720. doi: 10.3390/cancers14225720.
PubMed 36428812
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Auditory Distraction for the Relief of Pain and Anxiety
- ClinicalTrials.gov ID
- NCT07023692
- Acronym / sponsor ID
- 2024-02133-01
- Conditions
- Bone Marrow Aspiration, Pain, Anxiety, Hematologic Diseases, Hematologic Disorders, Visual Distraction
- Keywords
- pain perception, anxiety, nociceptive response, relief of pain, relief of anxiety, visual distraction, auditory distraction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Jun 2025 (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.
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.
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 1) will be conducted to gain a deeper understanding of patients' experiences of undergoing bone marrow examinations as part of standard practice. 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Distraction with VR (Virtual Reality) headsetsDistraction with VR headsets during bone marrow examinations |
| Control group | No intervention | –Bone marrow examinations according to standard procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (≥18 years) patients
- Adult (≥18 years) healthy volunteers without a hematological diagnosis undergoing bone marrow examination (aspiration and/or biopsy) at the Hematology Out-Patient Care Unit at SUS in Lund, Sweden.
Key exclusion criteria (7 listed)
- Individuals who cannot understand information and instructions
- Pregnant women
- Persons with skin injuries at the bone marrow examination site
- Those unable to lie on their side
- hearing and/or severe vision impairment
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 |
|---|---|---|
| Distraction with VR (Virtual Reality) headsetsVR headsets will be fitted and applied in consultation with the study participants. Distraction material will be selected from a range of options based on the participant's preferences, such as watching/listening to a story, an experience of being in nature, or mindfulness. When applying the VR headsets, care will be taken to ensure no light leaks into the eyes and that the headband and headphones are not perceived as too tight. This is especially important in terms of the risk for motion sickness (cyber sickness). The VR headsets will then be used throughout the examination procedure and removed once the bandage has been applied. | Behavioural | Intervention group |
Primary outcome
Nociceptive response
Time frame: Periprocedural
Objective markers measuring the level of pain, nociceptive response, monitored by using the the NOL technique, which presents an indexed value between 0 and 100 (i.e. units on a scale), where a higher score means worse outcome, i.e., higher nociceptive response.
Nociceptive response
Time frame: Periprocedural
Objective markers measuring the level of pain, nociceptive response, monitored by using the the MedStorm PainSensor technique, which presents an indexed value between 0 and 10 (i.e. units on a scale), where a higher score means worse outcome, i.e., higher nociceptive response.
Self-reported subjective health
Time frame: Immediately after the bone marrow examination - Periprocedural
Questionnaires will be given to the study participants with validated self-reported instrument Perceived Health: RAND-36 - RAND Corporation (Research and Development), reporting a score, 0 - 100 points on a scale, where a higher score means better outcome, i.e. the better health.
Self-reported subjective pain
Time frame: Immediately after the bone marrow examination - Periprocedural
Questionnaires will be given to the study participants with the validated self-reported instrument Self-reported Pain: NRS - Numerical Rating Scale, where pain is indicated on a scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
Self-reported subjective anxiety
Time frame: Immediately after the bone marrow examination - Periprocedural
Questionnaires will be given to the study participants with the validated self-reported instrument Self-reported Anxiety: STAI - State-Trait Anxiety Inventory. A score will be reported on a scale, where the scores range between 20-80 points, where a higher score means worse outcome, i.e., higher scores indicating higher levels of anxiety.
1 secondary outcome
Heart rate
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- BackgroundJildenstal P, H.K., Almskog K, et al., Monitoring the Nociception Level Intraoperatively - An Initial Experiences. J Anest & Inten Care, 2018. Med. 7(2): p. 555709.
- Background: PubMed 18352969Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.
- Background: PubMed 11491194Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089.
- Background: PubMed 15465944Karsh BT. Beyond usability: designing effective technology implementation systems to promote patient safety. Qual Saf Health Care. 2004 Oct;13(5):388-94. doi: 10.1136/qhc.13.5.388.
- Background: PubMed 15535533Rycroft-Malone J. The PARIHS framework--a framework for guiding the implementation of evidence-based practice. J Nurs Care Qual. 2004 Oct-Dec;19(4):297-304. doi: 10.1097/00001786-200410000-00002. No abstract available.
- Background: PubMed 39891061Norbeck DW, Lindgren S, Wolf A, Jildenstal P. Reliability of nociceptive monitors vs. standard practice during general anesthesia: a prospective observational study. BMC Anesthesiol. 2025 Jan 31;25(1):51. doi: 10.1186/s12871-025-02923-4.
- Background: PubMed 27171828Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
- Background: PubMed 6707862Spielberger CD, Vagg PR. Psychometric properties of the STAI: a reply to Ramanaiah, Franzen, and Schill. J Pers Assess. 1984 Feb;48(1):95-7. doi: 10.1207/s15327752jpa4801_16. No abstract available.
- Background: PubMed 9272792Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain. 1997 Aug;72(1-2):95-7. doi: 10.1016/s0304-3959(97)00005-5.
- Background: PubMed 18487245Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.
- Background: PubMed 18042882Hoffman HG, Richards TL, Van Oostrom T, Coda BA, Jensen MP, Blough DK, Sharar SR. The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments. Anesth Analg. 2007 Dec;105(6):1776-83, table of contents. doi: 10.1213/01.ane.0000270205.45146.db.
- Background: PubMed 36222814Soret L, Gendron N, Rivet N, Chocron R, Macraigne L, Clausse D, Cholley B, Gaussem P, Smadja DM, Darnige L. Pain Assessment Using Virtual Reality Facemask During Bone Marrow Aspiration: Prospective Study Including Propensity-Matched Analysis. JMIR Serious Games. 2022 Oct 12;10(4):e33221. doi: 10.2196/33221.
- We have extensive clinical and research networks both nationally and internationally, including groups from Lund University and Gothenburg University with extensive knowledge and experience in pain management.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) is not of any value to be shared since the focus is to gather data on a group level.
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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.
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 Distraction with VR (Virtual Reality) headsets in people with Bone Marrow Aspiration and Pain, run by Region Skane at 1 site in Sweden.
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 2 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 19 Aug 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Nociceptive response (time frame: Periprocedural). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07023692, which also lists 24 linked publications.
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 19 Aug 2026.