AzTrials
AzTrials

Virtual RealityNCT07081425

Surgical Drain Removal: Pain and Anxiety Management

A study testing VRG Group in people with Virtual Reality and Pain Management, run by Kocaeli University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: Surgical drain removal may cause pain and anxiety in patients after bariatric surgery. Virtual reality may reduce procedure-related discomfort by directing attention away from painful stimuli. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
VRG Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2023to 1 Nov 2024
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Being 18 years of age or older.
  • Not having any psychiatric illness, dizziness, vision, hearing, or perception problems.
  • Being willing to participate in the study.

Who cannot join

  • Use of painkillers before the procedure.
  • Use of anxiety medication before the procedure.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kocaeli Health and Tecnology University

    Kocaeli, 41275

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Virtual Reality Intervention on Pain and Anxiety During Drain Removal: Randomized Controlled Study

Background: Surgical drain removal may cause pain and anxiety in patients after bariatric surgery. Virtual reality may reduce procedure-related discomfort by directing attention away from painful stimuli. This study evaluated the effect of virtual reality on pain and state anxiety during surgical drain removal after bariatric surgery.

Methods: This randomized controlled trial was conducted with 60 adult patients who underwent bariatric surgery in a private hospital in Kocaeli, Türkiye. Participants were randomly assigned to a virtual reality group or a control group at a 1:1 ratio. Patients in the intervention group watched a standardized 360° nature video using virtual reality goggles before and during drain removal, while patients in the control group received routine care. Pain was assessed using the Numerical Rating Pain Scale, and anxiety was evaluated using the State Anxiety Inventory. Outcomes were measured before and immediately after drain removal. The collected data were statistically analyzed.

Read the detailed description

While virtual reality glasses (VRG) were initially used primarily for gaming and entertainment purposes, today they have begun to find wide application areas in the healthcare sector, especially in education, treatment, rehabilitation, and pain management (Ehizogie Paul Adeghe et al., 2024; Kafes \& Ileri, 2025). VR technology has begun to gain an increasingly important place in the healthcare field with its continued development. VR increases the participation of patients in the treatment process and enables the development of more effective and personalized treatment methods (Pillai \& Mathew, 2019). VR is an important tool for improving the quality of healthcare by improving treatment processes, supporting the training of healthcare professionals, and enriching the patient experience (Buztepe \& Çapik, 2024).

When we look at the areas of use of virtual reality glasses in health, it is used in the treatment of phobias (Isikli et al., 2019) In the rehabilitation processes of pain management (Baghaei et al., 2021; Çevik Aktura et al., 2022; Hoşgör, 2022). Surgical interventions are an important turning point for patients, both physically and psychologically. Factors such as the invasive effects of surgery, damage to body tissues, and removal of foreign objects from the body can cause both physical pain and psychological concerns in patients. Acar (2016) concluded in his research that 77.3% of patients had complaints about pain after the surgical procedure (Acar et al., 2016).

Postoperative pain is a significant complication that negatively affects the patient's physical and psychological health, reduces the quality of life, and prolongs treatment processes. Therefore, effective management of postoperative pain is of great importance for a faster recovery and increased quality of life for the patient (Gürkan et al., 2020). This situation becomes more evident, especially in procedures such as the removal of surgical drains. The pain and anxiety experienced during the removal of drains can negatively affect the recovery process of patients, increase the use of painkillers, cause longer hospital stays, and reduce the overall quality of life (Çevik Aktura et al., 2022) The management of pain and anxiety experienced by patients after surgical interventions is of great importance for both patient comfort and the success of the treatment process. In a study conducted by Vazquez et al. in 2019 with patients undergoing cardiac surgery, the effects of the virtual reality experience were examined. Significant decreases in respiratory rate, mean arterial pressure, pain, and anxiety levels were observed in patients who experienced VR (Agrawal et al., 2019).

VR can help reduce pain by providing a distracting and relaxing environment (Değirmen et al., 2022) . According to the results of a different study, VR stands out as an effective alternative treatment method in acute pain management, especially in young people. VR has been successful in reducing the severity of different types of pain, such as postoperative dressing changes, burn wound dressings, and needlestick and peripheral catheter insertion (Güler et al., 2024; Saleh \& Abozed, 2024; Sariköse \& Turan, 2024). VR also improved the patient's overall well-being by reducing anxiety, discomfort, and time spent thinking about pain, which negatively impact the patient's overall pain experience (Huang et al., 2022). In cases such as post-operative dressing and drain removal, VR can help reduce pain by distracting the patient and help patients cope with these discomforts by providing relaxing and calming experiences in virtual environments. Since there is no study in the literature on the evaluation of pain and anxiety during drain removal, our study aimed to determine the effect of VR on pain and anxiety levels during drain removal in patients undergoing bariatric surgery.

MATERIAL METHODS Study type: Randomized controlled trial Study sample: This randomized controlled trial was conducted with patients undergoing bariatric surgery in a hospital in Kocaeli, Türkiye. The sample consists of 60 patients who underwent bariatric surgery and met the inclusion criteria for the study (experimental group n=30; control group n=30). The size of the study sample was determined statistically by power analysis. The sample size of each group was calculated as 30 patients for a power of 0.80 and a type I error of 0.05. The calculation was made using the PASS13.0 program (PASS, Kaysville, Utah, USA). Participants were assigned to two groups by computer software using a simple randomization method. During the sample selection of the study, 4 patients who met the inclusion criteria were not included in the study because they did not want to use VRG.

Inclusion Criteria for the Study: Being 18 years of age or older, not having any psychiatric illness, dizziness or vision, hearing, or perception problems, and being willing to participate in the study..

Data collection: Data were collected in the surgical clinic of a private hospital in Kocaeli province between April 2023 and November 2024. "Personal Information Form", "Numerical Rating Pain Scale"(NRPS), and "State Anxiety Inventory (STAI-I)" were used to collect the data.

Personal Information Form: It is a form prepared by researchers that includes questions about demographic data and the surgical history of patients used in similar studies in the literature (Abbasnia et al., 2023; Aslan et al., 2025; Ceyhan et al., 2018; Güler et al., 2024; Sariköse \& Turan, 2024). The form included questions about the patient's characteristics (age, gender, place of residence, education level), surgery history, and information about the current surgery (presence of previous surgery, type of current surgery, and time of last analgesia application).

Numerical Rating Pain Scale: It is a one-dimensional scale that determines the severity of pain in adult patients and is frequently used in pain assessment in the literature (Adeboye et al., 2021; Chiarotto et al., 2019; Kim et al., 2022; Özyer \& Köse, 2023; Savaş \& Kahyaoğlu Süt, 2024). Scores range from 0 to 10, with Zero generally representing "no pain at all," while the upper limit represents "worst possible pain." Higher scores indicate greater pain intensity.

State Anxiety Inventory (STAI-I): The State Anxiety Inventory (STAI-I) determines how an individual feels at a certain moment and under certain conditions. STAI-I was developed by Spielberger in 1970, and its Turkish form was adapted by Öner and Le Compte (1983), and its validity and reliability study was conducted. The scale consists of 20 items. Responses are scored between 1-4. The total score obtained from the scale is between 20-80. A high score indicates a high level of anxiety (Öner \& Le Compte, 1983; Spielberger et al., 1970).

Equipment: "VR Box V2.0 Virtual Reality Headset 3D" was used as virtual reality glasses. The device is compatible with Android operating systems and smartphones. The headset can be adjusted to the individual after being attached. A suitable program that allows 360° VR viewing can be downloaded to a compatible mobile phone, and the relevant content can be watched through the program. In this study, the researcher's mobile phone was used for VRG. Previously downloaded 360° videos of at least 5 minutes about nature-forest walks, underwater life, and the sky were presented according to the patients' preferences.

Application: In routine practice, considering the general condition of patients undergoing bariatric surgery, the drain is removed on the 3rd day. Care was taken to ensure that patients did not receive analgesia for at least 4 hours before the procedure. Before drain removal, the patient's NRPS level was assessed, and the STAI-I questionnaire was filled out. The experimental group was given a video to watch before the procedure began, and the use of glasses was explained. VRG was put on the patient, and the drain was removed in the 3rd minute while the video was being watched. After the procedure, the patients' pain perception during the procedure was assessed with the NRPS form. The STAI-I questionnaire was filled out again.

Ethical Aspect of the Study: The study protocol was approved by a university's non-interventional research ethics committee (Date-Decision No:23.03.2023;14/4), and institutional permission was obtained from the hospital administration (Decision No: 14839) where the study was conducted. The ethical principles of the Declaration of Helsinki were followed, and after informing the patients about the study, their verbal and written consents were obtained..

Data Analysis: The data obtained in the study were analyzed using SPSS 25 software. The normal distribution between the variables was analyzed with the 'Shapiro-Wilk', and the homogeneity of the distribution was analyzed with the Levene test. Pearson Correlation analysis was used to determine the correlation between two variables with a normal distribution. Independent Samples t test was used for comparisons between independent groups, and p<0.05 level was considered statistically significant.

Being tested
VRG Group
Keywords
virtual reality, Pain management, Perioperative Nursing, Surgıcal Drain Removal, Non-pharmacological method
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRG GroupDevice

    Also called Nonpharmacologıcal Pain Method

    Care was taken to ensure that patients did not receive analgesia for at least 4 hours before the procedure. Before drain removal, the patient's NRPS level was assessed, and the STAI-I questionnaire was filled out. The experimental group was given a video to watch before the procedure began, and the use of glasses was explained. VRG was put on the patient, and the drain was removed in the 3rd minute while the video was being watched. After the procedure, the patients' pain perception during the procedure was assessed with the NRPS form. The STAI-I questionnaire was filled out again.

Study groups in NCT07081425
Study groupRoleWhat they receive
VRG GroupExperimentalThe "VR Box V2.0 Virtual Reality Headset 3D" was used as the "virtual reality glasses" used in the study. The device is compatible with Android operating systems and smartphones. It is not a medical device. The headset can be adjusted to the person after being worn. A suitable program that provides 360° VR viewing can be downloaded to a compatible mobile phone and the relevant content can be watched through the program. In this study, the researcher's mobile phone was used for VRG. Patients were shown previously downloaded 360° videos featuring nature and forest walks lasting at least 5 minutes.. The participant was told that he/she could withdraw from this study at any time without giving any reason.
Receives: Device: VRG Group
Control GroupNo interventionIn routine practice, considering the general condition of patients undergoing bariatric surgery, the drain is removed on the 3rd day. Care was taken to ensure that patients did not receive analgesia for at least 4 hours before the procedure. Before the drain was removed, the patient's NRPS level was assessed and the STAI-I questionnaire was filled out. The drain was removed. After the procedure, the patients' pain perception during the procedure was assessed with the NRPS form. The STAI-I questionnaire was filled out again.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numerical Pain Rating Scale (SAAS)

    Numerical pain rating scale (NPRS) is used to evaluate pain severity. In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).The patient's pain was assessed using the NPRS 15 minutes before surgical drain removal. The drain was removed, and the removal process took 5 minutes. After the procedure, the patient's pain perception during drain removal was re-examined using the NPRS

    Measured: Perioperative/Periprocedural

  2. State Anxiety Scale (STAI TX-I)

    The State Anxiety Inventory (STAI TX-I) items are answered by selecting one of the following options, depending on the severity of the emotion or behavior: (1) not at all, (2) a little, (3) a lot, or (4) a lot. There are two types of statements on the scale: reversed or direct. Reversed statements express positive emotions, while direct statements express negative emotions. When scoring reversed statements, items with a weight of 1 are converted to 4, and those with a weight of 4 are converted to 1.

    The State Anxiety Inventory has ten reversed statements: items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The reversed and direct statements are added together during scoring. A higher total score indicates a higher anxiety level. The patient was asked to complete the STAI-I form 15 minutes before the drain removal procedure. The drain was removed, and the removal procedure took 5 minutes. After the procedure, the patient's anxiety during drain removal was re-evaluated using STAI-I.

    Measured: Perioperative/Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start1 Apr 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Nov 2024

Resources

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
Randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07081425
Sponsor's protocol ID
123456789
Status last verified
Aug 2026
First submitted
7 Jul 2025
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I can allow my article to be shared after it is published

Publications

  • Baghaei N, Chitale V, Hlasnik A, Stemmet L, Liang HN, Porter R. Virtual Reality for Supporting the Treatment of Depression and Anxiety: Scoping Review. JMIR Ment Health. 2021 Sep 23;8(9):e29681. doi: 10.2196/29681.

    PubMed 34554097
  • Chiarotto A, Maxwell LJ, Ostelo RW, Boers M, Tugwell P, Terwee CB. Measurement Properties of Visual Analogue Scale, Numeric Rating Scale, and Pain Severity Subscale of the Brief Pain Inventory in Patients With Low Back Pain: A Systematic Review. J Pain. 2019 Mar;20(3):245-263. doi: 10.1016/j.jpain.2018.07.009. Epub 2018 Aug 10.

    PubMed 30099210
  • Adeboye A, Hart R, Senapathi SH, Ali N, Holman L, Thomas HW. Assessment of Functional Pain Score by Comparing to Traditional Pain Scores. Cureus. 2021 Aug 3;13(8):e16847. doi: 10.7759/cureus.16847. eCollection 2021 Aug.

    PubMed 34522490
  • Abbasnia F, Aghebati N, Miri HH, Etezadpour M. Effects of Patient Education and Distraction Approaches Using Virtual Reality on Pre-operative Anxiety and Post-operative Pain in Patients Undergoing Laparoscopic Cholecystectomy. Pain Manag Nurs. 2023 Jun;24(3):280-288. doi: 10.1016/j.pmn.2022.12.006. Epub 2023 Jan 17.

    PubMed 36658058
  • Agrawal AK, Robertson S, Litwin L, Tringale E, Treadwell M, Hoppe C, Marsh A. Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. Pediatr Blood Cancer. 2019 Feb;66(2):e27525. doi: 10.1002/pbc.27525. Epub 2018 Oct 26.

    PubMed 30362236
  • Buztepe S, Capik C. The validity and reliability of the emotional consequences of elder abuse scale for Turkish language. BMC Geriatr. 2025 May 23;25(1):369. doi: 10.1186/s12877-025-06026-0.

    PubMed 40410670
  • Kafes, M., & Ileri, Y. Y. (2025). Current status of virtual reality research in healthcare: thematic and bibliometric analysis. Frontiers in Virtual Reality, 6.

  • Adeghe, E. P., Okolo, C. A., & Ojeyinka, O. T. (2024). A review of the integration of virtual reality in healthcare: implications for patient education and treatment outcomes. Int J Sci Technol Res Arch, 6(1), 79-88. https://doi.org/10.53771/ijstra.2024.6.1.0032

Questions about this trial

What is this clinical trial studying?

A study testing VRG Group in people with Virtual Reality and Pain Management, run by Kocaeli 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 3 inclusion and 2 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 Aug 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?

Numerical Pain Rating Scale (SAAS) (time frame: Perioperative/Periprocedural). The study lists 2 primary outcomes in all. 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 NCT07081425, which also lists 8 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 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in