Protocol summary

Study aim
This study aims to: investigates the effect of virtual reality on anxiety, stress, and hemodynamic parameters among primiparous women during cesarean section.
Design
parallel, group, Non blind, Randomized controlled clinical trial
Settings and conduct
operating theater / Maternal and Children Hospital in Najran city.
Participants/Inclusion and exclusion criteria
Inclusion criteria were parturient with normal vision and hearing abilities, no history of generalized anxiety disorder or mental illness, free from serious obstetrics complications (according to the obstetrician evaluation), no increased intraoperative risk (e.g., placental disturbance) that identified in the preoperative period and accept to participate on the study. Any woman developed intraoperative complication will be excluded from the study.
Intervention groups
For the intervention group, the virtual reality glass (VR) will be applied after regional anesthesia; then, hemodynamic parameters were assessed before intervention, immediately after anesthesia, skin incision, delivery, skin suture, and two hours after surgery. Anxiety will be reassessed at siting on surgery table, after completing skin suturing, and recovery time (2 hours postoperative). Stress will be reassessed after completing skin suture and two hours post-operative. Women is also asked about her satisfaction about the care provided.
Main outcome variables
Anxiety, Stress, and Hemodynamic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210131050192N2
Registration date: 2021-08-06, 1400/05/15
Registration timing: registered_while_recruiting

Last update: 2021-08-06, 1400/05/15
Update count: 0
Registration date
2021-08-06, 1400/05/15
Registrant information
Name
Wafaa Elgzar
Name of organization / entity
Damanhour University
Country
Egypt
Phone
+20 13 2265261
Email address
wafaa.elgzar@nur.dmu.edu.eg
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-12-30, 1400/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Virtual Reality on Anxiety, Stress, and Hemodynamic parameters among Primiparous Women During Cesarean Section: A Randomized controlled Clinical Trial
Public title
The Effect of Virtual Reality on Anxiety, Stress, and Hemodynamic parameters among Primiparous Women During Cesarean Section: A Randomized controlled Clinical Trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parturient with normal vision Parturient with normal hearing No history of generalized anxiety disorder No history of mental illness Free from serious obstetrics complications (according to the obstetrician evaluation) No increased intraoperative risk (e.g., placental disturbance) that identified in the preoperative period Accept to participate on the study.
Exclusion criteria:
Any woman developed intraoperative complication will be excluded from the study.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 350
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly assigned to intervention or control group through randomization block technique. Six steps were followed to carryout participants' assignment using randomization block technique. First, the investigators will write a list contains numbers from 1 to 350. Second; the investigators will prepare small pieces of papers that comprise numbers from 1 to 350. Third; the investigators will fold each piece of papers to hide the written number, then it will be collected in a large bowl. Fourth; the researchers divided the 350 pieces of papers into 35 blocks in a random and blind manner. Each block contains 10. Fifth; from each block, five pieces of papers will be selected randomly and blindly to the intervention group and the remaining 5 pieces of papers will be assigned to the control group. A total of 175 numbers will be assigned to each group. Sixth; the classification of cases will be recorded in the pre-prepared list (the word intervention or control will be recorded in front of each number) to be considered at the time of data collection. The intervention group (G1) included 175 participants and the control group (G2) involved 175 patients who will be submitted to routine care.
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
Najran University ethics committee
Street address
Elmashalia Najran University campus
City
Najran
Postal code
55461
Approval date
2021-04-25, 1400/02/05
Ethics committee reference number
25-04-2021-3NEC

Health conditions studied

1

Description of health condition studied
Caesarian section
ICD-10 code
O34.21
ICD-10 code description
Maternal care for scar from previous cesarean delivery

Primary outcomes

1

Description
Stress
Timepoint
Stress will be reassessed after completing skin suture and two hours post-operative. Women is also asked about her satisfaction about the care provided.
Method of measurement
Part III: Emotional preoperative stress (B-MEPS)Caumo (2016) first developed this scale, it will be developed to measure the emotional preoperative stress. It composed of 15 items, 3 of them rated on 4-point Likert scale, 11 of them rated on 3-point Likert scale and one of the have two answers. The high score indicates high stress.

2

Description
Anxiety
Timepoint
Anxiety will be reassessed at siting on surgery table, after completing skin suturing, and recovery time (2 hours postoperative).
Method of measurement
Part: IV: A novel visual facial anxiety scale for assessing preoperative anxiety Cao et al, 2017 developed this scale. This Self-reported scale to measure anxiety during clinical practices. It composed of six faces that asses different degrees of anxiety from none (1), mild (2), mild-moderate (3), moderate (4), moderate-high (5) and highest (6). The highest score indicates high degree of anxiety.

3

Description
Hemodynamic parameters and fetal APGR score
Timepoint
hemodynamic parameters were assessed before intervention, immediately after anesthesia, skin incision, delivery, skin suture, and two hours after surgery.
Method of measurement
Part II: Maternal hemodynamic parameters and newborn APGAR assessment sheet:The researchers developed this part after reviewing the current literature. This part will be used to register the maternal pulse, systolic, diastolic and mean blood pressure, respiratory rate and o2 saturation at patient admission, skin incision, delivery, skin suture and two hours after surgery. This part also contained questions about the incidence of nausea and drowsiness or vomiting. At the end of this part fetal APGAR sheet is present to asses at 1 and 5 minutes.

Secondary outcomes

empty

Intervention groups

1

Description
For the intervention group, the virtual reality glass (VR) will be applied after regional anesthesia; then, hemodynamic parameters were assessed before intervention, immediately after anesthesia, skin incision, delivery, skin suture, and two hours after surgery. Anxiety will be reassessed at siting on surgery table, after completing skin suturing, and recovery time (2 hours postoperative). Stress will be reassessed after completing skin suture and two hours post-operative. Women is also asked about her satisfaction about the care provided.
Category
Treatment - Other

2

Description
For the control group, they were left for routine hospital care. The same measurement timing for stress, anxiety, hemodynamic parameters neonatal APGAR score and maternal satisfaction about care provided were followed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Maternal and Children Hospital in Najran city
Full name of responsible person
Heba Abdine
Street address
Elmashalia Najran University campus
City
Najran
Postal code
55461
Phone
+966 17 542 8888
Email
wafaa.elgzar@nur.dmu.edu.eg

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Najran University
Full name of responsible person
Wafaa Taha Elgzar
Street address
Elmashalia Najran University campus
City
Najran
Postal code
66241
Phone
+966 17 542 8888
Email
wafaa.elgzar@nur.dmu.edu.eg
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Najran University
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
Najran University
Full name of responsible person
Wafaa Taha Elgzar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Obstetrics and gynecology nursing
Street address
Elmashalia Najran University campus
City
Najran
Province
Najran
Postal code
66241
Phone
+966 17 542 8888
Email
wafaa.elgzar@nur.dmu.edu.eg

Person responsible for scientific inquiries

Contact
Name of organization / entity
Najran University
Full name of responsible person
Wafaa Taha Elgzar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
obstetrics and gynecology nursing
Street address
Elmashalia Najran University campus
City
Najran
Province
Najran
Postal code
66241
Phone
+966 17 542 8888
Email
wafaa.elgzar@nur.dmu.edu.eg

Person responsible for updating data

Contact
Name of organization / entity
Najran University
Full name of responsible person
Wafaa Taha Elgzar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
obstetrics and gynecology
Street address
Elmashalia Najran University campus
City
Najran
Province
Najran
Postal code
66241
Phone
+966 17 542 8888
Email
wafaa.elgzar@nur.dmu.edu.eg

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
Yes - There is 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
published research report that contains all the study findings
When the data will become available and for how long
within one year and will be available long life
To whom data/document is available
public
Under which criteria data/document could be used
for scientific use and public education
From where data/document is obtainable
non
What processes are involved for a request to access data/document
non
Comments
non
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