Anxiety, Surgical Preparation, and Recovery Process in Colorectal Cancer SurgeryNCT07294690
The Effect of Preoperative Training With Virtual Reality on Anxiety, Readiness for Surgery and Recovery Process of Patients in Colorectal Cancer Surgery
A study testing Patients undergoing colorectal surgery will be trained using virtual reality glasses. in people with Anxiety, Surgical Preparation, and Recovery Process in Colorectal Cancer Surgery, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to determine the effect of The Effect of Preoperative Training with Virtual Reality on Anxiety, Readiness for Surgery and Recovery Process of Patients in Colorectal Cancer Surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety, Surgical Preparation, and Recovery Process in Colorectal Cancer Surgery
- What is being tested?
- Patients undergoing colorectal surgery will be trained using virtual reality glasses.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2025to 15 Jan 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreement to participate in the study, Ability to read and write in Turkish, Being conscious and communicative.
Who cannot join
- Those with any psychiatric illness, Those diagnosed with an anxiety disorder and taking medication for anxiety, Those with active nausea, vomiting, or headache, Those with vision or hearing problems, Those with a history of seizures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul University-Cerrahpasa
Istanbul, 34090
Özkan Karadede, Msc, +905067705766
About this study
The aim of the study is to determine the effect of The Effect of Preoperative Training with Virtual Reality on Anxiety, Readiness for Surgery and Recovery Process of Patients in Colorectal Cancer Surgery.
Research Hypotheses
Read more
In patients undergoing colorectal surgery:
H1 The comfort level of patients who received preoperative training using virtual reality is higher than that of patients who received training using written brochures and the control group.
H2. The anxiety level of patients who received preoperative education using the virtual reality method is lower than that of patients who received education via written brochures and the control group.
H3 The satisfaction level of patients who received preoperative education using the virtual reality method is lower than that of patients who received education via written brochures and the control group.
- Being tested
- Patients undergoing colorectal surgery will be trained using virtual reality glasses.
- Keywords
- colorectal surgery, Anxiety, Surgical Preparation, Recovery Process
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing colorectal surgery will be trained using virtual reality glasses.Device
Patients undergoing colorectal surgery will be trained using virtual reality glasses.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| virtual reality group | Experimental | Patients undergoing colorectal surgery will be trained using virtual reality glasses. Receives: Device: Patients undergoing colorectal surgery will be trained using virtual reality glasses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
(State Trait Anxiety Inventory I-II)
STAI I determines how an individual feels at a specific moment and under specific conditions. The State-Trait Anxiety Inventory (STAI II) determines how individuals generally feel in their current situation and conditions.
Inventory items are scored between 1 and 4. High scores on the inventory indicate that the person has high levels of state and trait anxiety. Scores between 0 and 19 on the inventory indicate no anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-80 points indicate severe anxiety.
Measured: 24 hour
The Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ)
The scale determines whether the verbal and written information provided about the surgery prepares individuals for the surgery. The scale is a 4-point Likert scale ranging from positive to negative. The scale consists of a total of 24 items. The score that can be obtained from the scale ranges from 0 to 96. Item 24 on the scale is reverse-scored. The scale is evaluated by calculating the total score of the items. High scores indicate a high level of readiness.
Measured: 24 hour
Recovery Quality-40 Survey (QoR-40)
The scale consists of a total of 40 items. It comprises five subscales: emotional state, physical comfort, patient support, physical independence, and pain. The scale is a 5-point Likert scale, and items are scored on a scale of 1 to 5. Subscale averages are obtained by summing the scores for each subscale, and the total survey score is obtained by summing all items. A higher score indicates that patients' physical and emotional well-being is at the expected level (good condition) post-surgery. A low score indicates that the patient's well-being post-surgery has been negatively affected.
Measured: 24 hour
Secondary outcomes (2)
Cortisol Level
Cortisol, commonly known as the "stress hormone," is essential for life. When stress occurs, cortisol levels increase. Cortisol is secreted by the adrenal cortex in response to various stimuli. It enables the organism to adapt to its environment. Cortisol helps the organism defend against dangers by enhancing its homeostasis ability. Cortisol levels were measured using saliva samples taken at specified times.
Measured: 24 hour
Number of Steps
A pedometer wristband was used to monitor the patient's daily physical activities and determine the number of steps taken.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start5 May 2025
- Primary completion9 Dec 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety, Surgical Preparation, and Recovery Process in Colorectal Cancer SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkan Karadede, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294690
- Sponsor's protocol ID
- E-83045809-604.01-1017096
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) collected in this study will be shared with other researchers for scientific purposes. The data to be shared will include anonymized demographic characteristics, outcome measures, and variables used in the analyses, with no information that could directly or indirectly identify individual participants. Data will be made available after publication of the primary study results. Access to the data will be granted upon reasonable request, subject to submission of a written scientific proposal and confirmation of compliance with ethical standards. The data will be provided through a secure external data-sharing platform, and a link to the dataset will be made available in the ClinicalTrials.gov record when accessible.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Training With Virtual Reality on Anxiety, Readiness for Surgery and Recovery Process of Patients in Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07294690
- Acronym / sponsor ID
- E-83045809-604.01-1017096
- Keywords
- colorectal surgery, Anxiety, Surgical Preparation, Recovery Process
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 19 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 aim of the study is to determine the effect of The Effect of Preoperative Training with Virtual Reality on Anxiety, Readiness for Surgery and Recovery Process of Patients in Colorectal Cancer Surgery.
Research Hypotheses
In patients undergoing colorectal surgery:
H1 The comfort level of patients who received preoperative training using virtual reality is higher than that of patients who received training using written brochures and the control group.
H2. The anxiety level of patients who received preoperative education using the virtual reality method is lower than that of patients who received education via written brochures and the control group.
H3 The satisfaction level of patients who received preoperative education using the virtual reality method is lower than that of patients who received education via written brochures and the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| virtual reality group | Experimental | Device: Patients undergoing colorectal surgery will be trained using virtual reality glasses.Patients undergoing colorectal surgery will be trained using virtual reality glasses. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Agreement to participate in the study, Ability to read and write in Turkish, Being conscious and communicative.
Key exclusion criteria (1 listed)
- Those with any psychiatric illness, Those diagnosed with an anxiety disorder and taking medication for anxiety, Those with active nausea, vomiting, or headache, Those with vision or hearing problems, Those with a history of seizures
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 |
|---|---|---|
| Patients undergoing colorectal surgery will be trained using virtual reality glasses.Patients undergoing colorectal surgery will be trained using virtual reality glasses. | Device | virtual reality group |
Primary outcome
(State Trait Anxiety Inventory I-II)
Time frame: 24 hour
STAI I determines how an individual feels at a specific moment and under specific conditions. The State-Trait Anxiety Inventory (STAI II) determines how individuals generally feel in their current situation and conditions. Inventory items are scored between 1 and 4. High scores on the inventory indicate that the person has high levels of state and trait anxiety. Scores between 0 and 19 on the inventory indicate no anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-80 points indicate severe anxiety.
The Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ)
Time frame: 24 hour
The scale determines whether the verbal and written information provided about the surgery prepares individuals for the surgery. The scale is a 4-point Likert scale ranging from positive to negative. The scale consists of a total of 24 items. The score that can be obtained from the scale ranges from 0 to 96. Item 24 on the scale is reverse-scored. The scale is evaluated by calculating the total score of the items. High scores indicate a high level of readiness.
Recovery Quality-40 Survey (QoR-40)
Time frame: 24 hour
The scale consists of a total of 40 items. It comprises five subscales: emotional state, physical comfort, patient support, physical independence, and pain. The scale is a 5-point Likert scale, and items are scored on a scale of 1 to 5. Subscale averages are obtained by summing the scores for each subscale, and the total survey score is obtained by summing all items. A higher score indicates that patients' physical and emotional well-being is at the expected level (good condition) post-surgery. A low score indicates that the patient's well-being post-surgery has been negatively affected.
2 secondary outcomes
Cortisol Level
Time frame: 24 hour
Number of Steps
Time frame: 24 hour
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 19 Dec 2025.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) collected in this study will be shared with other researchers for scientific purposes. The data to be shared will include anonymized demographic characteristics, outcome measures, and variables used in the analyses, with no information that could directly or indirectly identify individual participants. Data will be made available after publication of the primary study results. Access to the data will be granted upon reasonable request, subject to submission of a written scientific proposal and confirmation of compliance with ethical standards. The data will be provided through a secure external data-sharing platform, and a link to the dataset will be made available in the ClinicalTrials.gov record when accessible.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients undergoing colorectal surgery will be trained using virtual reality glasses. in people with Anxiety, Surgical Preparation, and Recovery Process in Colorectal Cancer Surgery, run by Istanbul University - Cerrahpasa 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 1 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: looking for participants now, as of the sponsor's last update on 19 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?
Contact Özkan Karadede, MsC (+905067705766, ozkan.karadede@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(State Trait Anxiety Inventory I-II) (time frame: 24 hour). The study lists 3 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 19 Dec 2025.