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

Pain Management After Surgery Clinical Trial

— Pain  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436014
• Other study ID #: OsmaniyeKorkutAtaUniversity
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Osmaniye Korkut Ata University
• Contact: Songül GÜNGÖR, PhD
• Phone: +905064546790
• Email: songulgungor06[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Management After Surgery
• Pain, Postoperative

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.

Locations

Country	Name	City	State
Turkey	Osmaniye Korkut Ata University	Merkez	Osmani?ye
Turkey	Osmaniye State Hospital	Merkez	Osmani?ye

Sponsors (1)

Lead Sponsor	Collaborator
Osmaniye Korkut Ata University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The VR application is effective in changing postoperative pain.	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	The VR application is effective in changing postoperative anxiety.	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.