Pain Management After SurgeryPainNCT06436014
Evaluation of the Effect of Virtual Reality Application on Postoperative Pain and Anxiety in Women Aged 50-70
A study testing Providing VR experience in people with Pain Management After Surgery, run by Osmaniye Korkut Ata University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Pain Management After Surgery
- What is being tested?
- Providing VR experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jul 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Being on the first postoperative day,
- Scoring 5 or higher on the Visual Analogue Scale (VAS) assessment,
- Being able to speak and understand Turkish.
Who cannot join
- 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,
Show all 9Show fewer
- Having a Glasgow Coma Score \<15,
- Having psychiatric, cognitive, or neurological impairments,
- Having visual or hearing impairments.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Osmaniye Korkut Ata University
Center, Osmani̇ye, 80010
Songül GÜNGÖR, PhD, +9005064546790, songulgungor06@gmail.com
songulgungor06@gmail.com
Osmaniye State Hospital
Center, Osmani̇ye, 80010
About this study
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
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.
Read the 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.
- Conditions
- Pain Management After Surgery
- Being tested
- Providing VR experience
- Keywords
- Virtual Reality (VR), Postoperative Pain, Pain Management Patient Experience
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing VR experienceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The researcher's first visit to the patient on postoperative day 1.
Secondary outcomes (1)
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.
Measured: The researcher's first visit to the patient on postoperative day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Management After SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songul Gungor, Osmaniye Korkut Ata University
- Investigators
- Songül GÜNGÖR, Phd, Principal investigator, Osmaniye Korkut Ata UniversityAyşe TAŞTEKİN, associate professor, Study director, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436014
- Sponsor's protocol ID
- OsmaniyeKorkutAtaUniversity
- Acronym
- Pain
- Status last verified
- May 2024
- First submitted
- 2 Mar 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06436014
- Acronym / sponsor ID
- Pain / OsmaniyeKorkutAtaUniversity
- Conditions
- Pain Management After Surgery
- Keywords
- Virtual Reality (VR), Postoperative Pain, Pain Management Patient Experience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| Total Knee Replacement VR Intervention Group | Experimental | Other: Providing VR experiencePre-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. |
| 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 | Other: Providing VR experiencePre-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. |
| 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Providing VR experienceParticipants 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. | Other | Hysterectomy VR Intervention Group, Total Knee Replacement VR Intervention Group |
Primary outcome
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.
1 secondary outcome
The VR application is effective in changing postoperative anxiety.
Time frame: The researcher's first visit to the patient on postoperative day 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
Related trials for Pain Management After Surgery
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Songül GÜNGÖR, Phd principal investigator
Osmaniye Korkut Ata University
Ayşe TAŞTEKİN, associate professor study director
Afyonkarahisar Health Sciences University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Providing VR experience in people with Pain Management After Surgery, run by Osmaniye Korkut Ata University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Songül GÜNGÖR, PhD (+905064546790, songulgungor06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The VR application is effective in changing postoperative pain. (time frame: The researcher's first visit to the patient on postoperative day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.