Evaluation of the Effect of Virtual Reality Application on Postoperative Pain and Anxiety in Women Aged 50-70 (Pain)

May 28, 2024 updated by: Songul Gungor, Osmaniye Korkut Ata University

Evaluation of the Effect of Virtual Reality Application on Postoperative Pain and Anxiety in Women Aged 50-70 According to the Type of Surgery: A Randomized Controlled Trial

Surgical interventions, while significant milestones in patients' physical recovery processes, can be a major source of concern for patients due to postoperative pain, which is also an important component of postoperative care. If postoperative pain is not managed properly, it can lead to increased levels of anxiety and fear, as well as deterioration in overall comfort and quality of life. The ineffective management of postoperative pain has economic and medical consequences such as patient dissatisfaction, delayed hospital discharge, increased rates of hospital readmission, and dissatisfaction with medical care. Therefore, effective management of postoperative pain is of great importance for patient well-being. Factors associated with postoperative pain have been reported in many studies. For example, being female and the type of surgery. Therefore, considering gender and type of surgery in the management of postoperative pain is crucial to optimize the recovery process for patients. In recent years, research on the use of innovative technologies such as virtual reality in the management of postoperative pain has increased. Virtual reality can reduce postoperative pain by creating a sense of being in a different environment for patients and diverting their attention away from pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Understanding the use of virtual reality applications in the medical field and their effects on pain perception and sensitivity in women is important. This study aims to evaluate the potential impact of virtual reality technology on pain and anxiety during the postoperative period in women aged 50-70. The research will be conducted at Osmaniye State Hospital. The general hypotheses of this study are that virtual reality application is effective in reducing postoperative pain and anxiety. The sub-hypotheses aim to determine the effect of virtual reality application among women undergoing two different types of surgeries (total knee replacement and hysterectomy). The method used in the research includes a randomized controlled trial design, involving application and control conditions across four different groups. Data will be collected through a questionnaire. The questionnaire will gather participants' demographic information, and their pain levels will be assessed using the Visual Analogue Scale (VAS) while their anxiety levels will be evaluated using the Beck Anxiety Scale. After the pre-test, virtual reality application will be administered to experimental groups with two different types of surgeries. No intervention will be applied to the control group before the post-test. Ethical approval and written informed consent will be obtained from the participants. Participants' postoperative pain and anxiety levels, analgesic usage amounts and frequencies will be recorded, and feedback related to their virtual reality experiences will be obtained. In the study, the rotation method will be used to randomly assign participants to experimental and control groups. The rotation method aims to place each patient sequentially into the next group. For example, the first patient undergoing total knee replacement surgery will be assigned to Group 1, and then the second patient undergoing total knee replacement surgery will be assigned to Group 2, the first patient undergoing hysterectomy surgery will be assigned to Group 3, and the second patient undergoing hysterectomy surgery will be assigned to Group 4. Thus, separate control and application groups will be formed for each type of surgery. This study is original and important as it will be the first study in our country to evaluate the impact of virtual reality on pain and anxiety in 50-70-year-old women according to the type of surgery.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Osmani̇ye
      • Merkez, Osmani̇ye, Turkey, 80010
        • Osmaniye Korkut Ata University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Songül GÜNGÖR, PhD
        • Principal Investigator:
          • Ayşe TAŞTEKİN, associate professor
      • Merkez, Osmani̇ye, Turkey, 80010
        • Osmaniye State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 50-70,
  • Being female,
  • Having adequate vision and hearing,
  • Having American Society of Anesthesiologists (ASA) physical status classification I and II,
  • Undergoing elective total knee replacement or hysterectomy surgery,
  • Having a similar analgesia protocol,
  • Being on the first postoperative day,
  • Scoring 5 or higher on the Visual Analogue Scale (VAS) assessment,
  • Being able to speak and understand Turkish.

Exclusion Criteria:

  • Having chronic pain,
  • Scoring below 5 on the Visual Analogue Scale (VAS) assessment,
  • Experiencing vertigo or motion-sensitive nausea,
  • Being diagnosed with severe anxiety by a specialist physician,
  • Having claustrophobia,
  • Having head or neck conditions that prevent wearing virtual reality goggles,
  • Having a Glasgow Coma Score <15,
  • Having psychiatric, cognitive, or neurological impairments,
  • Having visual or hearing impairments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total Knee Replacement VR Intervention Group

Pre-Test + Intervention + Post-Test) (Participants who underwent total knee replacement Participants who underwent total knee replacement surgery and received a pre-test, followed by VR intervention.Participants in this group are initially assessed with VAS and Beck Anxiety Scale.

Subsequently, VR intervention is administered to this group. After the intervention, participants are reassessed with VAS and Beck Anxiety Scale.
Other: Providing VR experience
Participants undergoing VR intervention will experience a VR program of their choice based on personal preferences. Among these programs are videos offering natural visual experiences. For instance, participants can opt for videos featuring seaside views, forest tours, or lake landscapes.
No Intervention: Total Knee Replacement Control Group
Pre-Test (Participants who underwent total knee replacement surgery and received only a pre-test).Participants in this group are initially assessed with VAS and Beck Anxiety Scale.
Experimental: Hysterectomy VR Intervention Group
Pre-Test + Intervention + Post-Test) Participants who underwent hysterectomy surgery and received a pre-test, followed by VR intervention.Participants in this group are initially assessed with a pre-test, followed by VR intervention.
Other: Providing VR experience
Participants undergoing VR intervention will experience a VR program of their choice based on personal preferences. Among these programs are videos offering natural visual experiences. For instance, participants can opt for videos featuring seaside views, forest tours, or lake landscapes.
No Intervention: Hysterectomy Control Group
Participants who underwent hysterectomy surgery and received only a pre-test).Participants are assessed only with VAS and Beck Anxiety Scale after the intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The VR application is effective in changing postoperative pain.
Time Frame: The researcher's first visit to the patient on postoperative day 1.
Pretest with VAS is administered on the first postopera tive day to women aged 50-70 undergoing total knee replacement and hysterectomy. • Subsequently, VR intervention is conducted. • Following the intervention, participants are re-evaluated with VAS.
The researcher's first visit to the patient on postoperative day 1.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The VR application is effective in changing postoperative anxiety.
Time Frame: The researcher's first visit to the patient on postoperative day 1.

Pretest with Beck Anxiety Scale is administered on the first postoperative day

to women aged 50-70 undergoing total knee replacement and hysterectomy. • Subsequently, VR intervention is conducted. • Following the intervention, participants are re-evaluated with Beck Anxiety Scale.
The researcher's first visit to the patient on postoperative day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osmaniye Korkut Ata University

Investigators

  • Principal Investigator: Songül GÜNGÖR, Phd, Osmaniye Korkut Ata University
  • Study Director: Ayşe TAŞTEKİN, associate professor, Afyonkarahisar Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 2, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OsmaniyeKorkutAtaUniversity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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