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

NCT06883916 | Completed

• 1 other identifier: Faculty of Health Sciences
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Patients; Surgical Procedures, Elective; Anxiety

Keywords

preoperative anxiety; preoperative patients; complementary and alternative therapies; massage; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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 summing up items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by summing up items 2, 14, 16, and 17; and procedure-related anxiety is calculated by summing up items 1, 3, 4, and 5. The total score of the scale is calculated by summing up all sub-dimension scores and the scores of three items not included in the sub-dimensions. A minimum of 0 and a maximum of 68 points can be obtained from the scale. A high total scale score indicates increased surgical anxiety.

  The Surgical Anxiety Scale will be administered 5 minutes before the intervention assigned to the research groups (pre-test) and again 5 minutes after the completion of the massage or virtual reality intervention (post-test).

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Behavioral: Virtual reality tour

Massage

EXPERIMENTAL

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

Behavioral: Massage

Interventions

Virtual reality tour 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.

Virtual Reality

Massage 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.

Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Balcali Hospital Health Application and Research Center

Adana, Sarıçam, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27906757 BACKGROUND

• 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.

  PMID: 30324926 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sevban A Professor doctor

  Cukurova University

  STUDY DIRECTOR

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: Principal Investigator

Model Details: The study was conducted to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. It was planned as a three-group, randomized controlled and interventional study.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: March 19, 2025
• Study Start: August 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 6, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)