Clinical trial NCT06436014: Evaluation of the Effect of Virtual Reality Application on Postoperative Pain and Anxiety in Women Aged 50-70
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Management After Surgery
Keywords: Virtual Reality (VR)
Postoperative Pain
Pain Management Patient Experience
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 76
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 ( Pre-Test + Intervention + Post-Test) (Participants undergoing total knee replacement surgery, subjected to pre-test followed by VR intervention) Group 2 (receiving only pre-test) Group 3 (Intervention Only + Post-Test) (Participants undergoing hysterectomy surgery, subjected to pre-test followed by VR intervention) Group 4 (Post-Test Only) (Participants undergoing hysterectomy surgery, receiving only pre-test)
Primary purpose: SUPPORTIVE_CARE

Brief summary: Surgical interventions, while significant milestones in patients\&#39; 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.

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\&#39; 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\&#39; 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.

Eligibility criteria: 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 \&lt;15,
* Having psychiatric, cognitive, or neurological impairments,
* Having visual or hearing impairments.

Primary outcomes:
measure: The VR application is effective in changing postoperative pain.
timeFrame: The researcher's first visit to the patient on postoperative day 1.
Secondary outcomes:
measure: The VR application is effective in changing postoperative anxiety.
timeFrame: The researcher's first visit to the patient on postoperative day 1.
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Osmaniye Korkut Ata University
state: Osmani̇ye
city: Merkez
country: Turkey
facility: Osmaniye State Hospital
state: Osmani̇ye
Study officials:
affiliation: Osmaniye Korkut Ata University
name: Songül GÜNGÖR, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: Ayşe TAŞTEKİN, associate professor
role: STUDY_DIRECTOR
References: