Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes

NCT ID: NCT06883916

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-02-06

Brief Summary

The aim of this study is to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. In addition, it's examined that if virtual reality glasses and hand massage execution is convenient way of to reduce anxiety in patients before surgery.

The main questions it aims to answer are:

• Is there a significant difference between the study groups in terms of post-application anxiety level?
• Is there a significant difference between the study groups in terms of post-application vital signs, pain and patient satisfaction? Researchers will compare responses to anxiety scales before and after the hand massage and virtual reality videos to see if they reduce anxiety levels.

Participants will:

• In the virtual reality group, they will answer the questions on the surgical anxiety scale, watch the video with VR glasses and answer the questions on the scale again.
• In the massage group, they will answer the questions on the surgical anxiety scale, and after the researcher gives them a hand massage, they will answer the questions on the scale again.

Detailed Description

Surgical Anxiety Scale: The scale was developed by Burton et al. in 2018 to assess preoperative anxiety levels. Each item of the 17-item scale is answered between 0 and 5 points. It consists of three sub-dimensions reflecting individuals' health status, recovery process, and anxiety about procedures. Health-related anxiety is calculated by adding the scores given to items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by adding the scores given to items 2, 14, 16, and 17; and procedure-related anxiety is calculated by adding the scores given to items 1, 3, 4, and 5. The total score of the scale is calculated by adding the scores of all sub-dimensions and the scores of the three items not included in the sub-dimensions. A minimum of 0 and a maximum of 68 points can be obtained from the scale. Although there is no cut-off point for the scale, it can be said that surgical anxiety increases as the total score of the scale increases.

Conditions

Preoperative Patients; Surgical Procedures, Elective; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Virtual Reality

Patients in the preoperative waiting unit were shown a video using virtual reality glasses for 10 minutes.

Group Type: EXPERIMENTAL

Virtual reality tour

Intervention Type: BEHAVIORAL

The glasses have a pre-loaded video containing nature images in their memory. The patient feels like they are walking in the natural environment shown in the video.

Massage

A hand massage lasting 5 minutes was applied to each hand by the researcher.

Group Type: EXPERIMENTAL

Massage

Intervention Type: BEHAVIORAL

A hand massage was applied by the researcher for 5 minutes for each hand. The massage, which was performed using baby oil and a paper towel, lasted 10 minutes in total for both hands.

Interventions

Virtual reality tour

The glasses have a pre-loaded video containing nature images in their memory. The patient feels like they are walking in the natural environment shown in the video.

Intervention Type: BEHAVIORAL

Massage

A hand massage was applied by the researcher for 5 minutes for each hand. The massage, which was performed using baby oil and a paper towel, lasted 10 minutes in total for both hands.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients who will undergo elective surgery and whose general condition is ASA (American Society of Anesthesiology) classification I, II or III
• Patients who are not sedated
• Patients over the age of 18
• Patients without a psychiatric or behavioral diagnosis
• Patients who do not have a communication barrier due to hearing loss or spoken language

Exclusion Criteria

• Vertigo and motion sickness
• Carpal tunnel syndrome
• Hand cuts

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Nursevim Aydıngülü

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevban A Professor doctor

Role: STUDY_DIRECTOR

Cukurova University

Locations

Balcali Hospital Health Application and Research Center

Adana, Sarıçam, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.

Reference Type: BACKGROUND

PMID: 27906757 (View on PubMed)

Niharika P, Reddy NV, Srujana P, Srikanth K, Daneswari V, Geetha KS. Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars. J Indian Soc Pedod Prev Dent. 2018 Oct-Dec;36(4):364-369. doi: 10.4103/JISPPD.JISPPD_1158_17.

Reference Type: BACKGROUND

PMID: 30324926 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

View Document

Related Links

https://journals.lww.com/jped/fulltext/2018/36040/effects_of_distraction_using_virtual_reality.8.aspx

Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars

Other Identifiers

Faculty of Health Sciences

Identifier Type: -

Identifier Source: org_study_id