The effect of applying virtual reality technology with two approaches of distraction and patient education on preoperative anxiety and postoperative pain in patients undergoing laparoscopic cholecystectomy
Comparison of the two approaches using virtual reality distraction and patient education on the level of preoperative anxiety and postoperative pain in surgical patients undergoing laparoscopic cholecystectomy
Design
Clinical trials involving 165 patients with two intervention groups and one control group, with parallel groups, patients will be randomly divided into blocked methods by stata software.
Settings and conduct
This study will be performed in the surgical department of Mashhad educational hospitals.
After obtaining informed consent, patients' anxiety will be assessed using the Spielberger Anxiety Questionnaire before surgery and after preoperative intervention. The severity of the pain after the operation will be measured before each pair of glasses and after insertion through the visual acuity scale (VAS) and the McGill Pain Questionnaire.
Due to the type of research, it is not possible to blind the people under study and the researcher, but the statistical analyst and the allocator of the research units to the three groups will be unfavorable.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Uncomplicated cholelithiasis , Cholecystitis
Exclusion conditions:
History of gastrointestinal surgery over the past two weeks
History of vestibulocochlear abnormalities
History of seizures and epilepsy
Intervention groups
Intervention group 1 using virtual reality with a patient training approach before preoperative surgery a film about the operating room, after surgery: a pain with content controlling pain
In intervention group 2, use virtual reality to distract thoughts with the content of pleasant images in the two stages before and after the operation. In the control group, the usual training is performed
Main outcome variables
Anxiety of patients before surgery,
The severity of the pain after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047901N1
Registration date:2020-07-06, 1399/04/16
Registration timing:prospective
Last update:2020-07-06, 1399/04/16
Update count:0
Registration date
2020-07-06, 1399/04/16
Registrant information
Name
Fateme Abbasnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 3323
Email address
abbasniaf961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-10, 1399/04/20
Expected recruitment end date
2020-09-10, 1399/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of applying virtual reality technology with two approaches of distraction and patient education on preoperative anxiety and postoperative pain in patients undergoing laparoscopic cholecystectomy
Public title
The effect of virtual reality on anxiety and pain in patients undergoing laparoscopic cholecystectomy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Uncomplicated cholelithiasis , Cholecystitis
Lack of diagnosed mental disorder, lack of cognitive impairment, difficulty understanding the scale of pain
No addiction to opioids or strong painkillers
Lack of severe pain due to the nature of the disease (cancer)
Fluency in Persian
Exclusion criteria:
History of gastrointestinal surgery over the past two weeks
History of vestibulocochlear abnormalities
History of seizures and epilepsy
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequencing using stata software and block method. Blocks of sizes 6, 9, and 12 will be used to increase unpredictability. The group will be packed in an envelope and the envelopes will be sorted and numbered according to the generated sequence. After obtaining the informed consent, the first available envelope will be opened for each client and his group will be identified.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ibn Sina Ave, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.019
Health conditions studied
1
Description of health condition studied
Laparoscopic cholecystectomy patients with Cholelithiasis
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
2
Description of health condition studied
Laparoscopic cholecystectomy patients with Cholecystitis
ICD-10 code
K81
ICD-10 code description
Cholecystitis
Primary outcomes
1
Description
Postoperative pain scores measured in the McGill Pain Questionnaire and the Visual Analogue Scale
Timepoint
Measuring the amount of pain 4 hours after surgery (pre-intervention) and 15 minutes after intervention, every 4 hours to 24 hours after surgery
Anxiety score before surgery Spielberger questionnaire
Timepoint
Measure the amount of anxiety before surgery (before the intervention), 15 minutes after the intervention
Method of measurement
Through Spielberger's Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: First Intervention Group (Patients of Virtual Reality Technology Group with Patient Training Approach): Before Surgery: (After admission of the patient in the surgical ward) glasses are placed for the patient. Containing animated content for 5 minutes that simulates the operating room environment, anesthesia, surgery, and wakefulness. After surgery: 4 hours after the operation, the glasses are placed on the patient, which contains animated content, simulating deep breathing, how to get out of bed, effective cough, and changing position for 5 minutes. Wear glasses to control pain at least twice before bedtime
Category
Other
2
Description
Intervention group: The intervention group 2 (for groups of virtual reality technology with the approach of distraction)Before surgery: Glasses containing a film with music and soothing images will be played for 5 minutes via a virtual reality headset.After surgery: 4 hours after surgery at least twice before bedtime, if the patient interferes with sleep after sleep, the same images will be played and executed for the patient by the glasses.
Category
Other
3
Description
Control group: No specific action will be taken by the researcher, and the same hospital training, including educational pamphlets and face-to-face training, will be provided by the ward nurses for all patients.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Abbasnia Fateme
Street address
Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3840 0000
Email
abbasniaf961@mums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Abbasnia Fateme
Street address
Ibn Sina Ave،Crossroads Doctor
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3033
Email
abbasniaf961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aghebati Nahid
Street address
Ibn Sina Ave ،School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 1853 9775
Email
aghebatin@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abbasnia Fateme
Position
Nursing Graduate Student - Surgical
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Ave,School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
abbasniaf961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aghebati Nahid
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Ave, Faculty of Midwifery Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 1853 9775
Email
aghebatin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abbasnia Fateme
Position
Nursing Graduate Student - Surgical
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Ave, Faculty of Midwifery Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Abbasniaf961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
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
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Health centers
From where data/document is obtainable
Mashhad School of Nursing and Midwifery
What processes are involved for a request to access data/document
Immediately by visiting the library of Mashhad School of Nursing and Midwifery in person or online