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

NCT06436014 | Not Yet Recruiting DMC

• 1 other identifier: OsmaniyeKorkutAtaUniversity
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain Management After Surgery

Keywords

Virtual Reality (VR); Postoperative Pain; Pain Management Patient Experience

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The VR application is effective in changing postoperative anxiety.

  The researcher's first visit to the patient on postoperative day 1.

Study Arms (4)

Total Knee Replacement VR Intervention Group

EXPERIMENTAL

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

Total Knee Replacement Control Group

NO INTERVENTION

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.

Hysterectomy VR Intervention Group

EXPERIMENTAL

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

Hysterectomy Control Group

NO INTERVENTION

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.

Interventions

Providing VR experience OTHER

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.

Hysterectomy VR Intervention Group; Total Knee Replacement VR Intervention Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: Women aged 50-70 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osmaniye Korkut Ata University: lead

Study Sites (2)

Osmaniye Korkut Ata University

Merkez, Osmani̇ye, 80010, Turkey (Türkiye)

Location

Osmaniye State Hospital

Merkez, Osmani̇ye, 80010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Songül GÜNGÖR, Phd

  Osmaniye Korkut Ata University

  PRINCIPAL INVESTIGATOR

• Ayşe TAŞTEKİN, associate professor

  Afyonkarahisar Health Sciences University

  STUDY DIRECTOR

Central Study Contacts

Songül GÜNGÖR, PhD

CONTACT

+905064546790; songulgungor06@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Phd

Model Details: 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)

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: May 30, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

TU (2)