NCT07689461

Brief Summary

Total Hip Arthroplasty (THA), a procedure performed to enhance the quality of life, is accompanied by postoperative challenges such as pain and anxiety that adversely affect patient comfort. Inadequate management of these complications can prolong the length of hospital stay, delay recovery, lead to functional impairments, and elevate the risk of chronic pain development. Conventional pharmacological interventions employed for management are limited due to their potential for adverse effects and dependency. Virtual reality (VR) is a non-pharmacological distraction technique utilized in the healthcare sector, leveraging advanced technology to maximize patient comfort by alleviating pain and minimizing anxiety. A review of the literature reveals that while the use of VR has positive effects on pain and anxiety, there is a notable scarcity of high-quality randomized controlled trials concurrently evaluating its impact on pain, anxiety, and comfort levels in postoperative orthopedic procedures such as THA. In this randomized controlled trial, participants in the control group will receive standard care, whereas those in the experimental group will receive a 30-minute VR intervention-offering three distinct options-in addition to standard care during the acute phase of the first 48 hours. Postoperative assessments will be conducted using the Visual Analogue Scale (VAS) for pain intensity, the State Anxiety Inventory for anxiety levels, and the Perianesthesia Comfort Scale for comfort levels. By evaluating the potential of VR as a non-pharmacological adjuvant in post-THA care, the findings of this study will provide significant contributions to evidence-based nursing practices aimed at developing multimodal pain management strategies, reducing opioid consumption, and enhancing patient satisfaction.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Oct 2025Dec 2026

Study Start

First participant enrolled

October 21, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 1, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

Virtual RealityTotal Hip ArthroplastyPostoperative PainAnxietyComfort Level

Outcome Measures

Primary Outcomes (3)

  • Evaluation of Pain in Patients After Total Hip Arthroplasty Surgery

    The Visual Analog Scale (VAS) was used to measure pain intensity; it is a simple, unidimensional measure. It was developed by Price et al. in 1983 to assess perceived pain. Compared to the VAS scale, which is known to be more sensitive in the assessment and characterization of acute pain, "no pain" is rated as 0 points and "most severe pain" as 10 points. On this scale, an increase in score indicates an increase in pain. Pain is also categorized as mild (\<3), moderate (3-6), and severe (\>6).

    The first 24 hours after surgery, 25-48 hours after surgery

  • Evaluation of Anxiety in Patients After Total Hip Arthroplasty Surgery

    The Spielberger State-Trait Anxiety Inventory was used to assess patients' anxiety levels. The original scale was developed in 1970 by Spielberger and his team and adapted to the Turkish language and culture by Öner and Le Compte. Scale items are answered on a four-point Likert-type scale. For the state anxiety scale, the response options are "not at all," "a little," "a lot," and "completely," while for the trait anxiety scale, they are "never," "sometimes," "most of the time," and "almost always." Higher scores on the scale indicate higher levels of anxiety, while lower scores indicate lower levels of anxiety. According to the score ranges established by Spielberger and colleagues, a score of 0-19 indicates no anxiety, 20-39 indicates mild anxiety, 40-59 indicates moderate anxiety, and 60-79 indicates severe anxiety.

    The first 24 hours after surgery, 25-48 hours after surgery

  • Evaluation of Comfort Levels in Patients After Total Hip Arthroplasty Surgery

    The comfort levels of postoperative patients were assessed using the Perianesthesia Comfort Scale. The scale was developed by Kolcaba in 1990 and adapted into Turkish by Üstündağ and Aslan (2010). The Perianesthesia Comfort Scale (PCS) is a self-report assessment tool designed to measure individuals' comfort levels during the perianesthesia period. The scale consists of a total of 24 items and uses a six-point Likert-type scale. Participants respond to each item with scores ranging from "strongly disagree (1)" to "strongly agree (6)." The total score that can be obtained from the scale ranges from 24 to 144. The total score is divided by the number of items to calculate the mean score, which is expressed as a value between 1 and 6. A low mean score indicates a low level of comfort, while a high mean score indicates a high level of comfort.

    The first 24 hours after surgery, 25-48 hours after surgery

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in the experimental group will undergo a virtual reality headset intervention. This intervention will be administered to patients in the clinic during the acute phase-the first 48 hours following total hip replacement surgery. The scales used in the study will be administered twice: once before and once after the intervention.

Behavioral: cognitive intervention

Control Group

NO INTERVENTION

Participants in the control group will receive standard care. The intervention will be administered to patients who are in the clinic during the acute phase-the first 48 hours-following total hip replacement surgery. The scales used in the study will be administered twice: once before and once after the intervention.

Interventions

The patient undergoing the virtual reality session will lie in a supine position, supported and comfortable, with the head elevated at an angle of 30˚-45˚. The content will feature nature sounds and soothing background music; three different segments will be programmed: a forest or beach landscape, an underwater scene, and an outdoor excursion. Each option consists of 30 minutes of footage. The patient will select their preferred footage from these options, and after the sound settings are adjusted to a level the patient finds comfortable and non-disturbing, the session will begin and last for 30 minutes. Following the session, data will be collected in a face-to-face setting.

Experimental Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective surgery who agree to participate in the study,
  • Individuals 18 years of age or older,
  • Those with adequate cognitive function,
  • Those who have not previously undergone total hip replacement surgery,
  • Those who volunteer to participate in the study and sign the informed consent form,
  • Patients with a pain score (on a scale of 1 to 10) of 4 or higher were included in the study.

You may not qualify if:

  • Individuals under the age of 18,
  • Those previously diagnosed with a chronic pain syndrome (other than hip osteoarthritis),
  • Individuals with impaired cognitive function (severe psychiatric disorders),
  • Individuals who have previously undergone total hip replacement surgery,
  • Individuals with severe hearing or visual impairments,
  • Individuals with a history of opioid dependence,
  • Patients with a pain score (on a scale of 1 to 10) of 4 or lower were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Turgut Özal University

Malatya, 44900, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersPain, Postoperative

Condition Hierarchy (Ancestors)

Mental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • OĞUZHAN ÇAĞLAR, MSc Std

    Adiyaman University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

OĞUZHAN ÇAĞLAR, MSc Std

CONTACT

BİLSEV DEMİR, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

October 21, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Locations