Cholecystectomy, LaparoscopicNCT06634615
The Effect of Patient Education and in the Operating Room Family Interview Practices on Patient Outcomes Using Virtual Reality in Cholecystectomy Patients
A study testing VR patient education video and VR family interview in people with Cholecystectomy, Laparoscopic and Virtual Reality, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Virtual Reality, Patient Education
- What is being tested?
- VR patient education video and VR family interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital Prof. Dr. Asaf Ataseven Additional Service Building
Istanbul
Çağla Islattı Mutlu, 905434568906, caglaislatti@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cholecystectomy, Laparoscopic, Virtual Reality, Patient Education, Family Interviews, Operating Room, Anxiety
- Being tested
- VR patient education video, VR family interview
- Keywords
- Cholecystectomy, Virtual Reality, Patient Education, Operating Room Family Interview, Patient Outcomes, Anxiety, Stress, Sleep Quality, Patient Satisfaction
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR patient education videoOther
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.
VR family interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | 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. Receives: Other: VR patient education video |
| Education+Interview | Experimental | 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). |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
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.
Measured: 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
Total scale score is min. 6 and max. 30. High scores are associated with high anxiety levels and desire for information.
Measured: 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
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.
Measured: 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
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.
Measured: Post-op 1st day morning before discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start5 Jan 2025
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are three groups in the study: a patient education group with virtual reality glasses, a patient education group with virtual reality glasses and video family interview, and a control group without education and/or interview.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağla Islattı Mutlu, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634615
- Sponsor's protocol ID
- 09.2024.646
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06634615
- Acronym / sponsor ID
- 09.2024.646
- Conditions
- Cholecystectomy, Laparoscopic, Virtual Reality, Patient Education, Family Interviews, Operating Room, Anxiety
- Keywords
- Cholecystectomy, Virtual Reality, Patient Education, Operating Room Family Interview, Patient Outcomes, Anxiety, Stress, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- There are three groups in the study: a patient education group with virtual reality glasses, a patient education group with virtual reality glasses and video family interview, and a control group without education and/or interview.
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Other: VR patient education videoPatients 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. |
| Education+Interview | Experimental | –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). |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR patient education videoThe 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 | Education |
| VR family interviewPatients 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. | Other | – |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR patient education video and VR family interview in people with Cholecystectomy, Laparoscopic and Virtual Reality, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Çağla Islattı Mutlu (905434568906, caglaislatti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.