The Effect of Patient Education and in the Operating Room Family Interview Practices on Patient Outcomes Using Virtual Reality in Cholecystectomy Patients

May 8, 2025 updated by: Çağla Islattı Mutlu, Marmara University

The Effect of Patient Education and in the Operating Room Family Interview Practices on Patient Outcomes Using Virtual Reality in Cholecystectomy Patients: A Randomized Controlled Trial

This study was planned to be a randomized controlled experimental study to determine the effect of patient education and family interview practices using virtual reality on stress intensity, anxiety and information need levels, sleep quality and satisfaction with the preparation process for surgery in cholecystectomy patients. The main questions it aims to answer are:

  • Is there a significant difference in stress intensity, anxiety, and information need levels between patients who received and did not receive patient education with VR glasses in the ward before cholecystectomy surgery?
  • Is there a significant difference in stress intensity and anxiety levels between patients who received and did not receive video family interviews with VR glasses in the operative waiting area before cholecystectomy surgery?
  • Is there a significant difference in stress intensity, anxiety, and sleep quality levels at discharge of groups that received different VR interventions?
  • What is the postoperative sleep quality of patients with low preoperative anxiety levels?
  • What is the satisfaction of patients who received VR with the surgery preparation process? The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control, education, education+interview groups in accordance with the randomization list. Face-to-face communication will be established with each patient in the ward on the day of hospitalization, in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge. Depending on the groups in which the patients are included, they will be shown an educational video using virtual reality goggles and/or will be allowed to meet with their families. No application will be made to the control group and the ward routine will continue.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Virtual reality (VR) is an interactive field that offers sensory experiences such as three-dimensional vision, touch and hearing, allowing people to dive into the virtual world and feel that they are in a different environment. In healthcare services, it is seen that the effect of virtual reality technology on various patient outcomes has been examined by watching nature videos, training, exercise applications, museum tours with music and games. This study was planned to be a randomized controlled experimental study to determine the effect of patient education and family interview practices using virtual reality on stress intensity, anxiety and information need levels, sleep quality and satisfaction with the preparation process for surgery in cholecystectomy patients. G*Power (v3.1.9.7) program was used to determine the sample size in the study and considering possible losses, it was decided to include a total of 60 patients, 20 in each group.

During the data collection process, it is planned to include a total of six patients in the preliminary pilot application, two from the education group, two from the education+interview group, and two from the control group, for the comprehensibility and usability of the forms. Patients who have undergone preliminary application will not be included in the study. The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control, education, education+interview groups in accordance with the randomization list. Face-to-face communication will be established with each patient in the ward on the day of hospitalization, in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge. The first interview with the patients will be held in the patient room in the ward. During this interview, the patients will be invited to the study and the research will be explained. Informed voluntary consent will be obtained from the patients who agree to participate in the study. Depending on the groups in which the patients are included, they will be shown an educational video using virtual reality goggles and/or will be allowed to meet with their families. Data will be collected with the Introductory Information Form, Visual Analog Scale for Stress, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Richards Campbell Sleep Scale (RCBS), Virtual Reality Evaluation Form and Visual Analog Scale for Satisfaction. Oculus Quest 2 VR glasses will be used as a virtual reality application tool in the study.

The virtual family meeting will be initiated through the meeting link shared with the patients relative, and VR glasses and computer connection will be provided with the BigScreen computer application. Patients have a video call with their family in a 360° designed home environment. The conversations are easily transmitted thanks to the internal speaker and microphone in the VR glasses. In order to adjust the patients viewing angle, to provide guidance when needed, and to monitor communication, the image the patient sees in the VR glasses will be monitored with the Meta Quest program installed on the researchers mobile phone. The training video is a 2-3 minute animated video with visual and auditory elements and includes the ward nurse coming to the newly admitted patient in a patient room and giving information. In order to prevent infection, after each patients use, the supporting pads, straps, and lenses of the virtual reality glasses will be disinfected with cleaner and allowed to dry. It will be kept in its own box and offered to the other patients use.

In the first phase of the study with the patients in the control group, the data collection tools including the Introductory Information Form, the Visual Analog Scale for Stress, the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and the Richard-Campbell Sleep Scale (RCS) will be filled in on the day of admission. No intervention will be applied to the patients and routine procedures will continue. After 30 minutes, the patient will be asked to fill in the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) again. In the second phase of the study, when the patients are taken to the preoperative waiting area of the operating room, the data collection tools including the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) will be filled in. At the end of the period in which the patient waits to be taken to the operation, the patient will be asked to fill in the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) again. In the final phase of the study, the Stress visual analog scale, Amsterdam preoperative anxiety and information scale (APAIS), Richard-Campbell sleep scale (RCUS) and Satisfaction visual analog scale will be filled in the patient room before discharge on the morning of the first postoperative day.

In the first phase of the study, the patients in the patient education group will first fill out the data collection tools including the Introductory Information Form, Stress visual analog scale, Amsterdam preoperative anxiety and information scale (APAIS) and Richard-Campbell sleep scale (RCUS) on the day of admission. Then, a patient education video about laparoscopic cholecystectomy operation will be watched with virtual reality glasses. 30 minutes after watching the education video, patients will be asked to fill out the Stress visual analog scale and Amsterdam preoperative anxiety and information scale (APAIS) again. In the second phase of the study, when the patients are taken to the preoperative waiting area of the operating room, the Stress visual analog scale and Amsterdam preoperative anxiety and information scale (APAIS) will be filled in the data collection tools including the Stress visual analog scale and Amsterdam preoperative anxiety and information scale (APAIS). At the end of the waiting period for the patient to be taken to the operation, they will be asked to fill out the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale (APAIS) again. In the last stage of the study, on the morning of the first post-operative day, before discharge, the patient will be asked to fill out the data collection forms including the Stress Visual Analog Scale, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Richard-Campbell Sleep Scale (RCUS), Virtual Reality Evaluation Form and Satisfaction Visual Analog Scale in the patient room.

In the first stage of the study, the patients in the Education + Interview group will first fill out the data collection tools including the Introductory Information Form, Stress Visual Analog Scale, Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Richard-Campbell Sleep Scale (RCUS) on the day of admission. Then, a patient education video regarding laparoscopic cholecystectomy operation will be watched with virtual reality glasses. After watching the training video, patients will be asked to fill out the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale (APAIS) again 30 minutes later. In the second phase of the study, when patients are taken to the preoperative waiting area, data collection tools including the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale (APAIS) will be filled out. After the patient is put on virtual reality glasses and his/her vision is adjusted, a video family interview will be initiated. After the 5-minute virtual visit with the patients relative(s), the interview will be concluded and the Stress Visual Analog Scale, Amsterdam Preoperative Anxiety and Information Scale (APAIS) will be filled out again. In the last phase of the study, data collection forms including the Stress Visual Analog Scale, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Richard-Campbell Sleep Scale (RCUS), Virtual Reality Evaluation Form and Satisfaction Visual Analog Scale will be filled out in the patients room before discharge on the morning of the first postoperative day.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Recruiting
        • Marmara University Pendik Training and Research Hospital Prof. Dr. Asaf Ataseven Additional Service Building
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who volunteered to participate in the study,
  • who were 18 years of age or older,
  • who would undergo elective laparoscopic cholecystectomy surgery,
  • who had no vision, hearing and communication problems,
  • whose relatives had a smartphone and internet connection,
  • whose stress intensity was higher than 3 points (between 1-10 points) met the inclusion criteria.

Exclusion Criteria:

  • Patients with complaints of dizziness,
  • psychiatric disorders,
  • persistent sleep problems were excluded from the study.
  • Patients who voluntarily left the study,
  • interrupted the family video call with VR,
  • felt discomfort during VR application,
  • developed any allergy to the goggle material,
  • filled out the data collection forms incompletely and/or incorrectly will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Education
Patients in the education group will be shown a patient education video about the laparoscopic cholecystectomy operation with virtual reality glasses on the day of hospitalization.
Other: VR patient education video
The educational video is created by converting the information provided by the service nurses into a video when the patient is admitted to the ward for surgery. The video will show a 2-3 minute animation of a nurse giving information. In a patient room, the service nurse will come to the newly admitted patient and explain the concept of cholecystectomy, the reasons for removing the gallbladder, how laparoscopic cholecystectomy is performed, the advantages of laparoscopic surgery compared to open surgery, the preparation process before and on the day of surgery, the conditions to be monitored after surgery, the importance of nutrition and fluid intake, defecation, the importance of early mobilization and discharge.
Experimental: Education+Interview
Patients in the education+interview group will be shown a patient education video about the laparoscopic cholecystectomy operation with virtual reality glasses on the day of hospitalization. Patients in the education group will be shown a patient education video on laparoscopic cholecystectomy surgery with virtual reality glasses on the day of admission to the hospital. When patients are taken to the operative waiting area, virtual reality glasses will be put on and a 5-minute video family meeting will be initiated with the patient's relative(s).
Other: VR patient education video
The educational video is created by converting the information provided by the service nurses into a video when the patient is admitted to the ward for surgery. The video will show a 2-3 minute animation of a nurse giving information. In a patient room, the service nurse will come to the newly admitted patient and explain the concept of cholecystectomy, the reasons for removing the gallbladder, how laparoscopic cholecystectomy is performed, the advantages of laparoscopic surgery compared to open surgery, the preparation process before and on the day of surgery, the conditions to be monitored after surgery, the importance of nutrition and fluid intake, defecation, the importance of early mobilization and discharge.
Other: VR family interview
Patients will have a 5-minute video call with their families in a 360° designed home environment using virtual reality glasses in the operating room waiting area.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: On the day of hospitalization, during the first interview with the researcher and 30 minutes later; When arriving in the operating room waiting area and before going to the operation; On the morning of the first post-operative day, before discharge.
It is an 11-step scale ranging from 0-I am not stressed at all, to 10-I am very stressed, on a 10 cm ruler to assess the stress intensity of patients. The ruler shows that the stress level increases as it goes from 0 to 10.
On the day of hospitalization, during the first interview with the researcher and 30 minutes later; When arriving in the operating room waiting area and before going to the operation; On the morning of the first post-operative day, before discharge.
Anxiety and need for information
Time Frame: On the day of hospitalization, during the first interview with the researcher and 30 minutes later; When arriving in the operating room waiting area and before going to the operation; On the morning of the first post-operative day, before discharge.
Total scale score is min. 6 and max. 30. High scores are associated with high anxiety levels and desire for information.
On the day of hospitalization, during the first interview with the researcher and 30 minutes later; When arriving in the operating room waiting area and before going to the operation; On the morning of the first post-operative day, before discharge.
Sleep
Time Frame: On the day of hospitalization, during the first interview with the researcher and on the morning of the first postoperative day before discharge.
Each item of the scale is evaluated and answered on a chart ranging from 0 to 100. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep.
On the day of hospitalization, during the first interview with the researcher and on the morning of the first postoperative day before discharge.
Satisfaction with the preparation process for surgery
Time Frame: Post-op 1st day morning before discharge.
It is an 11-step scale ranging from 0-Not satisfied at all, 10-Very satisfied on a 10 cm ruler. The ruler shows that the level of satisfaction increases as it goes from 0 to 10.
Post-op 1st day morning before discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09.2024.646

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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