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CompletedNCT05899790VRanxietyUpdated Jun 12, 2023

The Effect of Information About the Operating Room Environment With Virtual Reality Glasses on the Anxiety Level

An interventional study of VR in Preoperative Anxiety, sponsored by Eastern Mediterranean University. Completed at 1 site in Cyprus. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-12.

Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Virtual Reality (VR) applications, one of the commonly emphasized approaches in the medical field recently, is in place as an intervention method applicable in various fileds of medicine for distraction, experiencing being exposed to events creating stress and palliating anxiety through providing materials which may distract the patient's attention from a stressful condition. The study has been planned in order to evaluate the effect of the notification regarding the theatre environment through virtual reality to the patients, who are to go through abdominal surgical intervention, on the anxiety level and the vital signs during the surgical intervention.

Being a non-pharmacological clinical randomize controlled one, the study shall be conducted in Dr. Burhan Nalbantoğlu State Hospital of TRNC Ministry of Health surgical service and preoperative waiting area.

Sample number has been determined through power analysis using G*Power 3.1.9.2 software. Taking (2017) "The effect of virtual reality in reducing preoperative anxiety in patients prior to arthroscopic knee surgery: A randomised controlled trial" study of Robertson and friends as the reference, the effect size, regarding the anxiety scores of experiment and control groups participants, has been determined as 0,63. Accordingly, sample size has been calculated as 71 people necessary for 95% (1-β=0,95) power at d=0,63 and α=0,05 levels. Taking into account there may be losses during the study, it has been planned to involve 80 people, so as to have 40 people per each group, in the study.

Since the patients, who are to be involved in the study, are not known; in order to assign same quantity of patients to each group prior to the study, randomization shall be done through using block randomization technique in GraphPad software so as to have 40 patients in the intervention group and 40 in the control group. The patients who receive standard clinical care prior to abdominal surgical intervention shall constitute the control group, the patients who receive information about operating room environment through VR goggles in addition to standard clinical care shall constitute the intervention group. The data shall be collected through "Individual characteristics Form", ''Patient Charts'', ''Surgical Anxiety Scale'', ''Galvanic Skin Sensor (GSS) Measurement Table''.

SPSS 26 Statistical analysis program shall be used for evaluating the study data. The acquired data shall be tested at 95% confidence interval, p\<0,05 level of significance. Number, percentage distributon and standard deviation for the definitive data analysis, chi square test for experiment and control groups' basic particulars similarity, Shapiro-Wilk for normality analysis of dependent variables, Student t test or Annova for the comparison of pre-test and final test scores of experiment control groups, the comparisons of variables giving normal distribution among the groups as per the normal distributon in the comparison of experiment control groups' pre-test and final test scores, Mann Whitney U test or Kruskal Wallis test for the variables of non-normal distribution shall be used.

Read the detailed description

Surgical interventions, which are widely used for health improvement and disease treatment, are one of the most important experiences in an individual's life. Surgical interventions, regardless of simple or life threatening, turn in to a condition leading to individual's loss of control on his body for a limited time and anxiety due to not having sufficient information about the subject although they are positive things which would provide recovery from illness. It is known that more medical complications build up in patients who have higher level of anxiety during the medical process. Although the factors, which trigger the anxiety, vary significantly among the individuals, the effects of common or lasting anxiety cases are usually similar. These factors may lead to effects such as pain, sinus tachycardia, hypertension, cardiac arrhythmia, surgical interventions, increase in anesthesia and analgesia necessities, latency in wound healing and discharge periods. Operating rooms being complex and unusual environments and getting anesthesia lead to anxiety and fear in patients. Since focusing on pharmacological intervetions in the current management of anxiety increases complications, which may build up inthe patient; easy to use, noninvasive non-pharmacological applications are required. Virtual Reality (VR) applications, one of the commonly emphasized approaches in the medical field recently, is in place as an intervention method applicable in various fileds of medicine for distraction, experiencing being exposed to events creating stress and palliating anxiety through providing materials which may distract the patient's attention from a stressful condition. The study has been planned in order to evaluate the effect of the notification regarding the theatre environment through virtual reality to the patients, who are to go through abdominal surgical intervention, on the anxiety level and the vital signs during the surgical intervention.

Being a non-pharmacological clinical randomize controlled one, the study shall be conducted in Dr. Burhan Nalbantoğlu State Hospital of TRNC Ministry of Health surgical service and preoperative waiting area. The criteria for being involved in the study have been defined as patients who are of 18 years old and over, are to go through abdominal surgical intervention, are conscious, have orientation of place-person and time, do not have any visual, audial or mental problem, have the ability of understanding the instructions of the study and reacting, can communicate in Turkish and give written approval for participating in the study. The criteria of being excluded form the study have been defined as the patients who regularly receive phytotherapy or pharmacotherapy for anxiety, are diagnosed with hypertension, cardiac arrhythmia, have facial injuries preventing comfortable utilization of VR hardware and are unpremedicated. The criteria of elimination from the study shall be composed of the patients who want to quit at own request, can not comply with the study process and conditions.

Sample number has been determined through power analysis using G*Power 3.1.9.2 software. Taking (2017) "The effect of virtual reality in reducing preoperative anxiety in patients prior to arthroscopic knee surgery: A randomised controlled trial" study of Robertson and friends as the reference, the effect size, regarding the anxiety scores of experiment and control groups participants, has been determined as 0,63. Accordingly, sample size has been calculated as 71 people necessary for 95% (1-β=0,95) power at d=0,63 and α=0,05 levels. Taking into account there may be losses during the study, it has been planned to involve 80 people, so as to have 40 people per each group, in the study.

Since the patients, who are to be involved in the study, are not known; in order to assign same quantity of patients to each group prior to the study, randomization shall be done through using block randomization technique in GraphPad software so as to have 40 patients in the intervention group and 40 in the control group. The patients who receive standard clinical care prior to abdominal surgical intervention shall constitute the control group, the patients who receive information about operating room environment through VR goggles in addition to standard clinical care shall constitute the intervention group. The data shall be collected through "Individual characteristics Form", ''Patient Charts'', ''Surgical Anxiety Scale'', ''Galvanic Skin Sensor (GSS) Measurement Table''.

SPSS 26 Statistical analysis program shall be used for evaluating the study data. The acquired data shall be tested at 95% confidence interval, p\<0,05 level of significance. Number, percentage distributon and standard deviation for the definitive data analysis, chi square test for experiment and control groups' basic particulars similarity, Shapiro-Wilk for normality analysis of dependent variables, Student t test or Annova for the comparison of pre-test and final test scores of experiment control groups, the comparisons of variables giving normal distribution among the groups as per the normal distributon in the comparison of experiment control groups' pre-test and final test scores, Mann Whitney U test or Kruskal Wallis test for the variables of non-normal distribution shall be used.

02

Conditions studied

  • Preoperative Anxiety

Keywords

  • Preoperative anxiety,
  • virtual reality,
  • abdominal surgery,
  • information about the operating room environment
03

In context

Lead sponsor

Eastern Mediterranean University is the lead sponsor of 141 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • who are of 18 years old and over,
  • are to go through abdominal surgical intervention,
  • are conscious, have orientation of place-person and time,
  • do not have any visual,
  • audial or mental problem,
  • have the ability of understanding the instructions of the study and reacting,
  • can communicate in Turkish
  • and give written approval for participating in the study

Exclusion criteria

Exclusion Criteria:

  • the patients who regularly receive phytotherapy or pharmacotherapy for anxiety,
  • are diagnosed with hypertension,
  • cardiac arrhythmia,
  • have facial injuries preventing comfortable utilization of VR hardware
  • and are unpremedicated.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • No intervention
    Control Group

    Forty patients who received standard care in the pre-abdominal surgery clinic and preoperative waiting area will form the control group.

  • Experimental
    intervention group

    In addition to standard care, 40 patients who were informed about the SG application and the operating room environment will form the intervention group.

    Other: VR

Interventions

  • OtherVR

    The first interview with the patients in the intervention group will be held in the afternoon, the day before the surgery. After completing the forms and scale the video containing information about the operating room environment will be applied to the patients through SG glasses and headphones. Before the surgical intervention, patients admitted to the pre-operative waiting area from the clinic, the video containing information about the operating room environment will be watched by the patients through SG glasses and headphones.

    Also known as: Virtual reality

06

What researchers measure

Primary outcomes

  1. Surgical Anxiety Scale

    maximum: 4 minimum: 0

    Time frame: two day

07

Study locations

1 site
  • Doğu Akdeniz Üniversitesi
    Famagusta, 99450, Cyprus
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05899790
Responsible party
Serpil ÇağlIyan payas (lecturer, Eastern Mediterranean University) — Principal investigator
First posted
Jun 12, 2023
Start date
Jun 29, 2022
Primary completion
Nov 15, 2022
Completion
Dec 15, 2022
Last update
Jun 12, 2023

Study contacts

serpil çağlıyan payas, lecturer
principal investigator · DOĞU AKDENİZ ÜNİVERSİTESİ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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