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

March 17, 2025 updated by: Nursevim Aydıngülü, Cukurova University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sarıçam
      • Adana, Sarıçam, Turkey
        • Balcali Hospital Health Application and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality
Patients in the preoperative waiting unit were shown a video using virtual reality glasses for 10 minutes.
Behavioral: 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.
Experimental: Massage
A hand massage lasting 5 minutes was applied to each hand by the researcher.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Anxiety Scale
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Study Director: Sevban A Professor doctor, Çukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

February 6, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Faculty of Health Sciences

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Since the research is conducted with real persons, sharing personal data is not ethically appropriate.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: Ethics Committee Approval

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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