Preoperative PatientsNCT06883916
Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes
A study testing Virtual reality tour and Massage in people with Preoperative Patients and Surgical Procedures, Elective, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Patients, Surgical Procedures, Elective, Anxiety
- What is being tested?
- Virtual reality tour and Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 6 Feb 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 will undergo elective surgery and whose general condition is ASA (American Society of Anesthesiology) classification I, II or III
- Patients who are not sedated
- Patients over the age of 18
- Patients without a psychiatric or behavioral diagnosis
- Patients who do not have a communication barrier due to hearing loss or spoken language
Who cannot join
- Vertigo and motion sickness
- Carpal tunnel syndrome
- Hand cuts
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balcali Hospital Health Application and Research Center
Adana, Sarıçam
About this study
The aim of this study is to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. In addition, it's examined that if virtual reality glasses and hand massage execution is convenient way of to reduce anxiety in patients before surgery.
The main questions it aims to answer are:
Read more
- Is there a significant difference between the study groups in terms of post-application anxiety level?
- Is there a significant difference between the study groups in terms of post-application vital signs, pain and patient satisfaction? Researchers will compare responses to anxiety scales before and after the hand massage and virtual reality videos to see if they reduce anxiety levels.
Participants will:
- In the virtual reality group, they will answer the questions on the surgical anxiety scale, watch the video with VR glasses and answer the questions on the scale again.
- In the massage group, they will answer the questions on the surgical anxiety scale, and after the researcher gives them a hand massage, they will answer the questions on the scale again.
Read the detailed description
Surgical Anxiety Scale: The scale was developed by Burton et al. in 2018 to assess preoperative anxiety levels. Each item of the 17-item scale is answered between 0 and 5 points. It consists of three sub-dimensions reflecting individuals' health status, recovery process, and anxiety about procedures. Health-related anxiety is calculated by adding the scores given to items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by adding the scores given to items 2, 14, 16, and 17; and procedure-related anxiety is calculated by adding the scores given to items 1, 3, 4, and 5. The total score of the scale is calculated by adding the scores of all sub-dimensions and the scores of the three items not included in the sub-dimensions. A minimum of 0 and a maximum of 68 points can be obtained from the scale. Although there is no cut-off point for the scale, it can be said that surgical anxiety increases as the total score of the scale increases.
- Being tested
- Virtual reality tour, Massage
- Keywords
- preoperative anxiety, preoperative patients, complementary and alternative therapies, massage, virtual reality
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality tourBehavioural
The glasses have a pre-loaded video containing nature images in their memory. The patient feels like they are walking in the natural environment shown in the video.
MassageBehavioural
A hand massage was applied by the researcher for 5 minutes for each hand. The massage, which was performed using baby oil and a paper towel, lasted 10 minutes in total for both hands.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Patients in the preoperative waiting unit were shown a video using virtual reality glasses for 10 minutes. Receives: Behavioral: Virtual reality tour |
| Massage | Experimental | A hand massage lasting 5 minutes was applied to each hand by the researcher. Receives: Behavioral: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Anxiety Scale
The scale was developed to assess preoperative anxiety related to surgery. It consists of subdimensions reflecting anxiety associated with health status, recovery, and surgical procedures. Subdimension scores are calculated using the relevant items, and the total score is obtained by combining these scores with additional items. Higher total scores indicate greater surgical anxiety.
Measured: The Surgical Anxiety Scale will be administered immediately before the intervention assigned to the research groups and again immediately after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Aug 2024
- Primary completion30 Dec 2024
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preoperative PatientsStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. It was planned as a three-group, randomized controlled and interventional study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursevim Aydıngülü, Cukurova University
- Investigators
- Sevban A Professor doctor, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883916
- Sponsor's protocol ID
- Faculty of Health Sciences
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the research is conducted with real persons, sharing personal data is not ethically appropriate.
Publications
Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.
PubMed 27906757Niharika P, Reddy NV, Srujana P, Srikanth K, Daneswari V, Geetha KS. Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars. J Indian Soc Pedod Prev Dent. 2018 Oct-Dec;36(4):364-369. doi: 10.4103/JISPPD.JISPPD_1158_17.
PubMed 30324926Aydingulu N, Arslan S. The Effect of a Virtual Reality Environment and Hand Massage Applied in the Preoperative Area on Patient Outcomes. J Perianesth Nurs. 2026 Jul 14:S1089-9472(26)00128-0. doi: 10.1016/j.jopan.2026.04.009. Online ahead of print.
PubMed 42446444
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes
- ClinicalTrials.gov ID
- NCT06883916
- Acronym / sponsor ID
- Faculty of Health Sciences
- Keywords
- preoperative anxiety, preoperative patients, complementary and alternative therapies, massage, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 19 Mar 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 this study is to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. In addition, it's examined that if virtual reality glasses and hand massage execution is convenient way of to reduce anxiety in patients before surgery.
The main questions it aims to answer are:
- Is there a significant difference between the study groups in terms of post-application anxiety level?
- Is there a significant difference between the study groups in terms of post-application vital signs, pain and patient satisfaction? Researchers will compare responses to anxiety scales before and after the hand massage and virtual reality videos to see if they reduce anxiety levels.
Participants will:
- In the virtual reality group, they will answer the questions on the surgical anxiety scale, watch the video with VR glasses and answer the questions on the scale again.
- In the massage group, they will answer the questions on the surgical anxiety scale, and after the researcher gives them a hand massage, they will answer the questions on the scale again.
Detailed description
Surgical Anxiety Scale: The scale was developed by Burton et al. in 2018 to assess preoperative anxiety levels. Each item of the 17-item scale is answered between 0 and 5 points. It consists of three sub-dimensions reflecting individuals' health status, recovery process, and anxiety about procedures. Health-related anxiety is calculated by adding the scores given to items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by adding the scores given to items 2, 14, 16, and 17; and procedure-related anxiety is calculated by adding the scores given to items 1, 3, 4, and 5. The total score of the scale is calculated by adding the scores of all sub-dimensions and the scores of the three items not included in the sub-dimensions. A minimum of 0 and a maximum of 68 points can be obtained from the scale. Although there is no cut-off point for the scale, it can be said that surgical anxiety increases as the total score of the scale increases.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was conducted to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. It was planned as a three-group, randomized controlled and interventional study.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual reality tourPatients in the preoperative waiting unit were shown a video using virtual reality glasses for 10 minutes. |
| Massage | Experimental | Behavioral: MassageA hand massage lasting 5 minutes was applied to each hand by the researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who will undergo elective surgery and whose general condition is ASA (American Society of Anesthesiology) classification I, II or III
- Patients who are not sedated
- Patients over the age of 18
- Patients without a psychiatric or behavioral diagnosis
- Patients who do not have a communication barrier due to hearing loss or spoken language
Key exclusion criteria (3 listed)
- Vertigo and motion sickness
- Carpal tunnel syndrome
- Hand cuts
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 |
|---|---|---|
| Virtual reality tourThe glasses have a pre-loaded video containing nature images in their memory. The patient feels like they are walking in the natural environment shown in the video. | Behavioural | Virtual Reality |
| MassageA hand massage was applied by the researcher for 5 minutes for each hand. The massage, which was performed using baby oil and a paper towel, lasted 10 minutes in total for both hands. | Behavioural | Massage |
Primary outcome
Surgical Anxiety Scale
Time frame: The Surgical Anxiety Scale will be administered immediately before the intervention assigned to the research groups and again immediately after completion of the intervention.
The scale was developed to assess preoperative anxiety related to surgery. It consists of subdimensions reflecting anxiety associated with health status, recovery, and surgical procedures. Subdimension scores are calculated using the relevant items, and the total score is obtained by combining these scores with additional items. Higher total scores indicate greater surgical anxiety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 27906757Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.
- Background: PubMed 30324926Niharika P, Reddy NV, Srujana P, Srikanth K, Daneswari V, Geetha KS. Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars. J Indian Soc Pedod Prev Dent. 2018 Oct-Dec;36(4):364-369. doi: 10.4103/JISPPD.JISPPD_1158_17.
- Derived from this study: PubMed 42446444Aydingulu N, Arslan S. The Effect of a Virtual Reality Environment and Hand Massage Applied in the Preoperative Area on Patient Outcomes. J Perianesth Nurs. 2026 Jul 14:S1089-9472(26)00128-0. doi: 10.1016/j.jopan.2026.04.009. Online ahead of print.
- Individual participant dataSharing planned: No. Since the research is conducted with real persons, sharing personal data is not ethically appropriate.
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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.
Sevban A Professor doctor study director
Cukurova 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 Virtual reality tour and Massage in people with Preoperative Patients and Surgical Procedures, Elective, run by Cukurova 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 5 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surgical Anxiety Scale (time frame: The Surgical Anxiety Scale will be administered immediately before the intervention assigned to the research groups and again immediately after completion of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06883916, which also lists 3 linked publications.
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 5 Oct 2026.