Clinical trial NCT06883916: Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes
Official title: Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Patients
Surgical Procedures, Elective
Anxiety
Keywords: preoperative anxiety
preoperative patients
complementary and alternative therapies
massage
virtual reality
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Surgical Anxiety Scale
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Balcali Hospital Health Application and Research Center
state: Sarıçam
Study officials:
affiliation: Çukurova University
name: Sevban A Professor doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.