Preoperative AnxietyNCT07297095
The Effect of Virtual Reality Education on Preoperative Anxiety, Postoperative Pain, and Sleep in Patients Undergoing Colon Surgery
A study testing preoperative patient education via virtual reality device in people with Preoperative Anxiety and Virtual Reality, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The effect of patient education given to patients undergoing colon surgery using virtual reality in the preoperative period on preoperative anxiety, postoperative pain and sleep is the subject of this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety, Virtual Reality, Postoperative Pain Management
- What is being tested?
- preoperative patient education via virtual reality device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 20 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 agree to participate in the study will be included:
- They are undergoing surgery for the first time,
- They have not received preoperative training,
- They will undergo colon surgery,
- They are over 18 years of age,
- They are eligible for the Virtual Reality Discomfort Questionnaire,
- They do not have claustrophobia.
Who cannot join
- Patients who have had multiple surgeries, Patients with head and neck, vision, or hearing problems that prevent them from wearing virtual reality glasses, Patients who had a stoma created during surgery, Patients who wish to withdraw from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing
Ankara
About this study
The effect of patient education given to patients undergoing colon surgery using virtual reality in the preoperative period on preoperative anxiety, postoperative pain and sleep is the subject of this study.
Read the detailed description
This study will be conducted to investigate the effects of patient education provided through virtual reality in the preoperative period to patients undergoing colon surgery on preoperative anxiety, postoperative pain, and sleep. The population of this randomized controlled experimental study will consist of patients who will undergo colon surgery in the General Surgery Department of a university hospital after obtaining ethics committee and institutional approval. The population of the study will consist of patients who will undergo colon surgery in the General Surgery Department of a university hospital after obtaining ethics committee and institutional approval. The required sample size and power calculations for this study were made using the G*Power 3.1.9.2 program. A type 1 error of 0.05, a confidence interval of 90%, and an effect size of 0.72 (Uğraş et al., 2023) were calculated. In the calculation, 41 patients were calculated for each of the intervention and control groups, and the number was increased by 10% to account for losses, with 45 patients each, for a total of 90 patients. "Patient Information Form", "Surgical Anxiety Scale", "Richard Campbell Sleep Scale", "Visual Analog Scale (VAS)" will be used as data collection tools. After completing the "Patient Information Form" on patients who provided informed consent, the "Surgical Anxiety Scale" will be administered to patients in the intervention and control groups upon admission. The intervention group will receive training using a 3D animated patient education video prepared with virtual reality glasses. The control group will receive routine verbal education. Following the training, the "Surgical Anxiety Scale" will be administered a second time to patients. Postoperative pain and sleep assessments will then be conducted in both the control and intervention groups. Pain intensity will be measured with the Visual Analog Scale (VAS) at the 8th, 16th, and 24th postoperative hours for both groups. Postoperative sleep quality will be assessed with the "Richard Campbell Sleep Scale" at the 24th postoperative hour for both groups. IBM SPSS Statistics 22.0 will be used for data analysis and evaluation.
- Being tested
- preoperative patient education via virtual reality device
- Keywords
- virtual reality, preoperative anxiety, postoperative sleep, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative patient education via virtual reality deviceOther
In the General Surgery Clinic, intervention group participants will receive training in the patient room using a virtual reality headset. The training video will include an introduction to the devices used in the ward during the preoperative period, from blood pressure cuffs to monitors. A training video will be prepared explaining that the patient will be monitored upon returning to the room after the surgery, will be monitored frequently, will be questioned about pain and sleep, and that their family and nurse will be available for any needs they may have.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Participants in the intervention group will receive training in the patient room of the General Surgery Clinic using a training video prepared with virtual reality glasses. The training video will include an introduction to the devices used in the ward during the preoperative period, from blood pressure cuffs to monitors. On the first postoperative day, the Richards Campbell Sleep Scale will be administered to the intervention and control groups. At 8, 16, and 24 hours, the intervention and control groups will be assessed for pain intensity using the Visual Analog Scale (VAS). Receives: Other: preoperative patient education via virtual reality device |
| control group | No intervention | The control group will receive routine verbal training as applied in the classical hospital procedure. The control group will receive routine verbal training as applied in the classical hospital procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analog Scale (VAS) Richard Campbell Sleep Quality Scale Surgical Anxiety Scale
The Visual Analog Scale (VAS) will be used in the study to assess patients' pain. It is a simple, effective, repeatable, and minimally instrumental measurement tool.
Richard Campbell Sleep Quality Scale Developed by Richards, this six-item scale measures the depth and quality of nighttime sleep, time to fall asleep, frequency of awakenings and duration of wakefulness, and ambient noise.
Surgical Anxiety Scale The scale has three subscales: health-related anxiety, recovery-related anxiety, and procedure-related anxiety.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start20 Nov 2025
- Primary completion1 May 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sema Koçaşlı, Assist. Prof. Dr., Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297095
- Sponsor's protocol ID
- 08/832
- Status last verified
- Nov 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Education on Preoperative Anxiety, Postoperative Pain, and Sleep in Patients Undergoing Colon Surgery
- ClinicalTrials.gov ID
- NCT07297095
- Acronym / sponsor ID
- 08/832
- Keywords
- virtual reality, preoperative anxiety, postoperative sleep, postoperative pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 22 Dec 2025 (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.
The effect of patient education given to patients undergoing colon surgery using virtual reality in the preoperative period on preoperative anxiety, postoperative pain and sleep is the subject of this study.
Detailed description
This study will be conducted to investigate the effects of patient education provided through virtual reality in the preoperative period to patients undergoing colon surgery on preoperative anxiety, postoperative pain, and sleep. The population of this randomized controlled experimental study will consist of patients who will undergo colon surgery in the General Surgery Department of a university hospital after obtaining ethics committee and institutional approval. The population of the study will consist of patients who will undergo colon surgery in the General Surgery Department of a university hospital after obtaining ethics committee and institutional approval. The required sample size and power calculations for this study were made using the G*Power 3.1.9.2 program. A type 1 error of 0.05, a confidence interval of 90%, and an effect size of 0.72 (Uğraş et al., 2023) were calculated. In the calculation, 41 patients were calculated for each of the intervention and control groups, and the number was increased by 10% to account for losses, with 45 patients each, for a total of 90 patients. "Patient Information Form", "Surgical Anxiety Scale", "Richard Campbell Sleep Scale", "Visual Analog Scale (VAS)" will be used as data collection tools. After completing the "Patient Information Form" on patients who provided informed consent, the "Surgical Anxiety Scale" will be administered to patients in the intervention and control groups upon admission. The intervention group will receive training using a 3D animated patient education video prepared with virtual reality glasses. The control group will receive routine verbal education. Following the training, the "Surgical Anxiety Scale" will be administered a second time to patients. Postoperative pain and sleep assessments will then be conducted in both the control and intervention groups. Pain intensity will be measured with the Visual Analog Scale (VAS) at the 8th, 16th, and 24th postoperative hours for both groups. Postoperative sleep quality will be assessed with the "Richard Campbell Sleep Scale" at the 24th postoperative hour for both groups. IBM SPSS Statistics 22.0 will be used for data analysis and evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: preoperative patient education via virtual reality deviceParticipants in the intervention group will receive training in the patient room of the General Surgery Clinic using a training video prepared with virtual reality glasses. The training video will include an introduction to the devices used in the ward during the preoperative period, from blood pressure cuffs to monitors. On the first postoperative day, the Richards Campbell Sleep Scale will be administered to the intervention and control groups. At 8, 16, and 24 hours, the intervention and control groups will be assessed for pain intensity using the Visual Analog Scale (VAS). |
| control group | No intervention | –The control group will receive routine verbal training as applied in the classical hospital procedure. The control group will receive routine verbal training as applied in the classical hospital procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who agree to participate in the study will be included:
- They are undergoing surgery for the first time,
- They have not received preoperative training,
- They will undergo colon surgery,
- They are over 18 years of age,
Key exclusion criteria (1 listed)
- Patients who have had multiple surgeries, Patients with head and neck, vision, or hearing problems that prevent them from wearing virtual reality glasses, Patients who had a stoma created during surgery, Patients who wish to withdraw from the study.
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 |
|---|---|---|
| preoperative patient education via virtual reality deviceIn the General Surgery Clinic, intervention group participants will receive training in the patient room using a virtual reality headset. The training video will include an introduction to the devices used in the ward during the preoperative period, from blood pressure cuffs to monitors. A training video will be prepared explaining that the patient will be monitored upon returning to the room after the surgery, will be monitored frequently, will be questioned about pain and sleep, and that their family and nurse will be available for any needs they may have. | Other | experimental |
Primary outcome
The Visual Analog Scale (VAS) Richard Campbell Sleep Quality Scale Surgical Anxiety Scale
Time frame: 6 month
The Visual Analog Scale (VAS) will be used in the study to assess patients' pain. It is a simple, effective, repeatable, and minimally instrumental measurement tool. Richard Campbell Sleep Quality Scale Developed by Richards, this six-item scale measures the depth and quality of nighttime sleep, time to fall asleep, frequency of awakenings and duration of wakefulness, and ambient noise. Surgical Anxiety Scale The scale has three subscales: health-related anxiety, recovery-related anxiety, and procedure-related anxiety.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Sema Koçaşlı, Assist. Prof. Dr. study director
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative patient education via virtual reality device in people with Preoperative Anxiety and Virtual Reality, run by Ankara Yildirim Beyazıt 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 7 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analog Scale (VAS) Richard Campbell Sleep Quality Scale Surgical Anxiety Scale (time frame: 6 month). 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 22 Dec 2025.