Surgical Drain Removal: Pain and Anxiety Management

NCT07081425 | Completed

• 1 other identifier: 123456789
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: The aim was to evaluate the effect of using virtual reality glasses (VRG) during surgical drain removal on participants' pain and anxiety levels. Study design: Randomized controlled trial Material and Method: Sixty participants (30 experimental, 30 control) who underwent obesity surgery at a hospital in Turkey were randomized and included in the study. VRG was used during drain removal in the experimental group. While collecting data, demographic data of the participants was collected with the Personal Information Form. Pain and anxiety levels were measured using the Numerical Rating Pain Scale (NRPS) and the State Anxiety Inventory (STAI-I) before and after the procedure. In the use of VRG, patients watched 360° videos with themes of nature, forests, underwater scenes, and the sky, depending on their preference. The collected data were statistically analyzed.

Conditions

Virtual Reality; Pain Management; Pain Management After Surgery; Anxiety After Surgery; Non-Pharmacological Pain Management; Perioperative Nursing; Surgical Drain

Keywords

virtual reality; Pain management; Perioperative Nursing; Surgıcal Drain Removal; Non-pharmacological method

Outcome Measures

Primary Outcomes (2)

• 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

  Perioperative/Periprocedural

• 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.

  Perioperative/Periprocedural

Study Arms (2)

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. Previously downloaded 360° videos of at least 5 minutes of nature-forest walks, underwater life and the sky were presented according to the patients' preferences. The participant was told that he/she could withdraw from this study at any time without giving any reason.

Device: VRG Group

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.

Interventions

VRG Group DEVICE

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.

Also known as: Nonpharmacologıcal Pain Method

VRG Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli Health and Tecnology University

Kocaeli, 41275, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 30099210 BACKGROUND

• 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.

  PMID: 34522490 BACKGROUND

• 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.

  PMID: 36658058 BACKGROUND

• 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.

  PMID: 30362236 BACKGROUND

• 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.

  PMID: 34554097 BACKGROUND

• 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.

  PMID: 40410670 BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Refiye Akpolat

  Kocaeli Sağlık ve Teknoloji Üniversitesi, Kocaeli, Türkiye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Profesor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 23, 2025
• Study Start: April 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)