A Comparative Study of Virtual Reality and Shot Blocker Maneuver for Managing Pain, Anxiety, and Vital Signs in Patients During Bone Marrow Aspiration and Biopsy: Randomized Controlled Trail
To compere effects of three maneuver (virtual reality, shot blocker and mixed maneuver).
Design
A factorial group, not blinding, A Randomized control Clinical trial
Settings and conduct
Medical City / Hematology Center / department of bone marrow aspiration in Iraq Single blind in this trial, the participant is kept blinded to their group assignment (interventions and control groups) throughout the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adult patient with undergoing bone marrow aspiration and biopsy local anesthetic.
Exclusion criteria: the patient’s withdrawal at any stage of the study, not using a virtual reality headset during bone marrow aspiration and biopsy.
Intervention groups
The samples will divide into four groups, first group will use virtual reality with natural video before 5-minute form start procedure, second group will apply shot blocker maneuver on site of insertion bone marrow aspiration device, third group will use two methods (virtual reality and shot blocker maneuver). The fourth group ( control group ) does not give any intervention.
Main outcome variables
Pain and anxiety and vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230310057672N6
Registration date:2025-01-29, 1403/11/10
Registration timing:prospective
Last update:2025-01-29, 1403/11/10
Update count:0
Registration date
2025-01-29, 1403/11/10
Registrant information
Name
Alaa Jawad
Name of organization / entity
University of Baghdad/College of Nursing
Country
Iraq
Phone
+964 1 521 1494
Email address
alaaj@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-06, 1403/11/18
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of Virtual Reality and Shot Blocker Maneuver for Managing Pain, Anxiety, and Vital Signs in Patients During Bone Marrow Aspiration and Biopsy: Randomized Controlled Trail
Public title
Effect of Virtual Reality and Shot Blocker for Managing Pain, Anxiety, and Vital Signs
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patient with undergoing bone marrow aspiration and biopsy local anesthetic, having no experience of bone marrow aspiration and biopsy
Full consciousness
No hearing and vision impairments based on the patient’s report.
Exclusion criteria:
The patient’s withdrawal at any stage of the study
Not using a VR headset during bone marrow aspiration and biopsy
Developing clinical instability during the procedure (such as loss of conscious- ness, cardiac and respiratory disorders, nausea, oculomotor issues).
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
223
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by using four cards blue, red, green, yellow put in the box the blue card represented virtual reality (A group), red card for shot blocker (B group), green card for virtual reality and shot blocker together (AB group), and yellow card for control (C group). Then all participant was allowed to choose one of these cards. No allocation concealment will be carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10045
Approval date
2024-11-06, 1403/08/16
Ethics committee reference number
34
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
3
Description of health condition studied
Changes in vital signs
ICD-10 code
Z01.3
ICD-10 code description
Encounter for examination of blood pressure
4
Description of health condition studied
Vital signs: heart rate
ICD-10 code
R00.0
ICD-10 code description
Tachycardia, unspecified
5
Description of health condition studied
Vital signs: Heart rate
ICD-10 code
R00.1
ICD-10 code description
Bradycardia, unspecified
6
Description of health condition studied
Vital signs: Breathing rate
ICD-10 code
R06
ICD-10 code description
Abnormalities of breathing
Primary outcomes
1
Description
anxiety
Timepoint
Five minutes before bone marrow aspiration - immediately after bone marrow aspiration
Method of measurement
stat-trait anxiety scale (STAS)
2
Description
Changes in vital signs
Timepoint
Five minutes before bone marrow aspiration - during bone marrow aspiration - 5 minutes after bone marrow aspiration
Method of measurement
Portable monitor device.
Secondary outcomes
1
Description
Pain
Timepoint
Immediately after bone marrow aspiration and biopsy.
Method of measurement
Visual analog scale (VAS) The VAS is a reliable, valid, responsive, and frequently used pain outcome measure. It consists of a bidirectional 10 cm straight line with two labels, that is, “no pain” and “worst possible pain”, located at either end of the line. Patients are instructed to draw a vertical mark on the line indicating their pain level The reliability data are VAS, (0.97). whereas (0) means no pain, the closer you are to number (10) means sever pain.
2
Description
Anxiety.
Timepoint
Immediately after bone marrow aspiration and biopsy
Method of measurement
Stat-trait anxiety scale (STAS) The 20-item SAI and the 20-item Trait Anxiety Inventory are independent of each other. In SAI, each item is scored in four-point Likert-type responses as follows: none: 1, a little: 2, a lot: 3, and completely: 4. In the Trait Anxiety Inventory, each item is scored in four-point Likert-type responses: rarely: 1, sometimes: 2, most of the time: 3, and almost always: 4. Higher scores indicate a higher level of anxiety, whereas low scores indicate that the anxiety level is low. In this study, Cronbach’s alpha value of the state anxiety inventory was found to be 0.937
3
Description
Vital signs (HR, BP, RR and SPo2) during procedure
Timepoint
Immediately after bone marrow aspiration and biopsy
Method of measurement
Portable monitor device: Vital signs are measured during and immediate after bone marrow aspiration and biopsy ( Patient's device manufacturer: Comen Magic Country: India Model: C86 Serial Number Kf200723063f).
Intervention groups
1
Description
Intervention group (A): virtual reality (VR) technology only, this group received virtual reality technology using Samsung gear VR The patient is placed in the prone position and the virtual reality goggles are placed on the patient's head before the bone marrow aspiration and biopsy procedure begins, where a video containing natural scenes is shown through the VR glosses and calm music. After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device.
Category
Treatment - Other
2
Description
Intervention group (B): The ShotBlocker is a diminutive, flat, U-shaped plastic apparatus adorned with rounded protuberances. It is applied to the skin during the administration of injections and operates by stimulating the nerve endings situated around the injection site. This tactile stimulation is posited to alleviate pain by temporarily obstructing the conveyance of pain signals to the central nervous system. ShotBlocker put on site of needle insertion of bone marrow aspiration device. After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device.
Category
Treatment - Other
3
Description
Intervention group (AB): virtual reality technology and ShotBlocker maneuver use during procedure and After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device.
Category
Treatment - Other
4
Description
Control group (C): Subjects in the control group with bone marrow aspiration and biopsy. No intervention was provided during the study. . After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of bone marrow aspiration / Hematology Center / Medical City
Full name of responsible person
Alaa Jawad Kadhim, Tahseen Faleh
Street address
Baghdad, Street 729
City
Baghdad
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Baghdad/College of Nursing
Full name of responsible person
Professor. Wissam Jabbar Qasim, PhD. Dean
Street address
Bab AL-Muadum campus
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The authors of the trial are the funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
University of Baghdad/college of Nursing
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad/college of Nursing
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad/college of Nursing
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be results of comparing the effect between intervention and control groups using reliable measures.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available for five months after the publications, after you are approved to register on the Iranian clinical trials website
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: alaaj@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
The processes involved in accessing this documentation are possible via email: alaaj@conursing.uobaghdad.edu.iq, the first and last name of authors, trial' title variable and the trial Id.
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors. The four groups were added individually in each field. We hope that the modifications will be appropriate to the design of the experiment. With many thanks and appreciation for your patience.