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Clinical Trials/NCT07081425
NCT07081425CompletedNot Applicable

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

Kocaeli University1 site in 1 country60 target enrollmentStarted: April 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Numerical Pain Rating Scale (SAAS)

Study Overview

Brief 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. 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

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

Arms & Interventions

VRG Group

Experimental

The "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.

Intervention: VRG Group (Device)

Control Group

No Intervention

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 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.

Outcomes

Primary Outcomes

Numerical Pain Rating Scale (SAAS)

Time Frame: Perioperative/Periprocedural

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

State Anxiety Scale (STAI TX-I)

Time Frame: Perioperative/Periprocedural

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.

Numerical Pain Rating Scale (SAAS)

Time Frame: Perioperative/Periprocedural

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

State Anxiety Scale (STAI TX-I)

Time Frame: Perioperative/Periprocedural

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Refiye Akpolat

Assist. Profesor

Kocaeli University

Study Sites (1)

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