The Effect of Patient Education and in the Operating Room Family Interview Practices on Patient Outcomes Using Virtual Reality in Cholecystectomy Patients

NCT06634615 | Recruiting

• 1 other identifier: 09.2024.646
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to be a randomized controlled experimental study to determine the effect of patient education and family interview practices using virtual reality on stress intensity, anxiety and information need levels, sleep quality and satisfaction with the preparation process for surgery in cholecystectomy patients. The main questions it aims to answer are:

• Is there a significant difference in stress intensity, anxiety, and information need levels between patients who received and did not receive patient education with VR glasses in the ward before cholecystectomy surgery?
• Is there a significant difference in stress intensity and anxiety levels between patients who received and did not receive video family interviews with VR glasses in the operative waiting area before cholecystectomy surgery?
• Is there a significant difference in stress intensity, anxiety, and sleep quality levels at discharge of groups that received different VR interventions?
• What is the postoperative sleep quality of patients with low preoperative anxiety levels?
• What is the satisfaction of patients who received VR with the surgery preparation process? The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control, education, education+interview groups in accordance with the randomization list. Face-to-face communication will be established with each patient in the ward on the day of hospitalization, in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge. Depending on the groups in which the patients are included, they will be shown an educational video using virtual reality goggles and/or will be allowed to meet with their families. No application will be made to the control group and the ward routine will continue.

Conditions

Cholecystectomy, Laparoscopic; Virtual Reality; Patient Education; Family Interviews; Operating Room; Anxiety; Stress; Sleep Quality; Patient Satisfaction; Patient Outcomes

Keywords

Cholecystectomy; Virtual Reality; Patient Education; Operating Room Family Interview; Patient Outcomes; Anxiety; Stress; Sleep Quality; Patient Satisfaction

Outcome Measures

Primary Outcomes (4)

• Stress

  It is an 11-step scale ranging from 0-I am not stressed at all, to 10-I am very stressed, on a 10 cm ruler to assess the stress intensity of patients. The ruler shows that the stress level increases as it goes from 0 to 10.

  On the day of hospitalization, during the first interview with the researcher and 30 minutes later; When arriving in the operating room waiting area and before going to the operation; On the morning of the first post-operative day, before discharge.

• Anxiety and need for information

  Total scale score is min. 6 and max. 30. High scores are associated with high anxiety levels and desire for information.

  On the day of hospitalization, during the first interview with the researcher and 30 minutes later; When arriving in the operating room waiting area and before going to the operation; On the morning of the first post-operative day, before discharge.

• Sleep

  Each item of the scale is evaluated and answered on a chart ranging from 0 to 100. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep.

  On the day of hospitalization, during the first interview with the researcher and on the morning of the first postoperative day before discharge.

• Satisfaction with the preparation process for surgery

  It is an 11-step scale ranging from 0-Not satisfied at all, 10-Very satisfied on a 10 cm ruler. The ruler shows that the level of satisfaction increases as it goes from 0 to 10.

  Post-op 1st day morning before discharge.

Study Arms (3)

Education

EXPERIMENTAL

Patients in the education group will be shown a patient education video about the laparoscopic cholecystectomy operation with virtual reality glasses on the day of hospitalization.

Other: VR patient education video

Education+Interview

EXPERIMENTAL

Patients in the education+interview group will be shown a patient education video about the laparoscopic cholecystectomy operation with virtual reality glasses on the day of hospitalization. Patients in the education group will be shown a patient education video on laparoscopic cholecystectomy surgery with virtual reality glasses on the day of admission to the hospital. When patients are taken to the operative waiting area, virtual reality glasses will be put on and a 5-minute video family meeting will be initiated with the patient's relative(s).

Control

NO INTERVENTION

Interventions

VR patient education video OTHER

The educational video is created by converting the information provided by the service nurses into a video when the patient is admitted to the ward for surgery. The video will show a 2-3 minute animation of a nurse giving information. In a patient room, the service nurse will come to the newly admitted patient and explain the concept of cholecystectomy, the reasons for removing the gallbladder, how laparoscopic cholecystectomy is performed, the advantages of laparoscopic surgery compared to open surgery, the preparation process before and on the day of surgery, the conditions to be monitored after surgery, the importance of nutrition and fluid intake, defecation, the importance of early mobilization and discharge.

Education

VR family interview OTHER

Patients will have a 5-minute video call with their families in a 360° designed home environment using virtual reality glasses in the operating room waiting area.

Eligibility Criteria

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

You may qualify if:

• Patients who volunteered to participate in the study,
• who were 18 years of age or older,
• who would undergo elective laparoscopic cholecystectomy surgery,
• who had no vision, hearing and communication problems,
• whose relatives had a smartphone and internet connection,

You may not qualify if:

• Patients with complaints of dizziness,
• psychiatric disorders,
• persistent sleep problems were excluded from the study.
• Patients who voluntarily left the study,
• interrupted the family video call with VR,
• felt discomfort during VR application,
• developed any allergy to the goggle material,
• filled out the data collection forms incompletely and/or incorrectly will be excluded from the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital Prof. Dr. Asaf Ataseven Additional Service Building

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Çağla Islattı Mutlu

CONTACT

905434568906; caglaislatti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Nurse

Model Details: There are three groups in the study: a patient education group with virtual reality glasses, a patient education group with virtual reality glasses and video family interview, and a control group without education and/or interview.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: January 5, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 9, 2025

Record last verified: 2024-09

Locations

TU (1)