The Effect Of Virtual Reality Glasses Applied During Pap Smear On Anxiety, Pain And Patient Satisfaction

NCT05895188 | Unknown

• 1 other identifier: DU-SBF-RS-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a randomized controlled experimental study designed to determine the effect of video, which is watched by virtual reality glasses during the procedure, on anxiety, pain and patient satisfaction to women who have had pap smear test.

Conditions

Anxiety; Pain; Patient Satisfaction

Keywords

Papanicolaou Test; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• Anxiety Level

  Anxiety will be measured with the Visual Analog Scale (VAS-Anxiety). The Anxiety Visual Analog Scale includes numbers from 0 to 10, the higher the number marked, the higher the level of anxiety felt.Anxiety level will be measured twice, before and after the procedure.

  15 minutes

• State Anxiety Level

  Anxiety level after the procedure will be measured with the State Anxiety Inventory (STAI I). The state anxiety scale measures the level of anxiety felt at the moment. It consists of 20 items, scores range from 20-80. The higher the score, the higher the level of anxiety felt. state anxiety level will be measured once after the pap smear process is completed.

  15 minutes

Secondary Outcomes (3)

• Pain Level

  15 minutes

• patient satisfaction level

  15 minutes

• virtual reality application satisfaction level

  15 minutes

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Before starting the process, participants will be informed about the study and their verbal and written consent will be obtained. Participants in the virtual reality group will be shown and introduced to virtual reality glasses before the procedure. After the woman goes to the examination table and takes the appropriate position for the pap smear procedure, virtual reality glasses will be put on the woman by the researcher. The selected video will be played until the Pap smear process is completed. (https://www.youtube.com/watch?v=6ud18oSuCiY\&t=30s). When the Pap smear is finished, the glasses will be removed and the woman will be helped to get up from the examination table. In this process, no form will be filled until the participant woman gets dressed and takes the ready position. Thus, the privacy of women will be protected and there will be no violation of ethical rights.

Device: Virtual Reality Glasses

Control Group

NO INTERVENTION

Verbal and written consent will be obtained from the participants before starting the procedure. No intervention will be applied to the participants in the control group. The forms that need to be filled before the procedure will be filled. With the help and guidance of the researcher, the woman will prepare, move to the examination table and take a position. After the Pap smear process is over, the participant woman will get off the examination table with the help of the researcher and get dressed. After the woman is ready after the procedure, she will go to the waiting room and fill out the forms.

Interventions

Virtual Reality Glasses DEVICE

From the beginning to the end of the procedure, women will watch the selected nature video.

Virtual Reality Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Being a woman to have a pap smear test
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A sufficient level of education to understand study procedures and be able to communicate with site personnel
• Being in the age range of 30-65,
• To have Pap Smear test for the first time,
• Speaking Turkish and reading and writing,
• No vision and hearing problems,
• Not using glasses,
• Not a diagnosed psychiatric disease.

You may not qualify if:

• Having any physical or mental problems that may prevent communication
• To have a Pap Smear test before.
• Removing virtual reality glasses during the process
• Not filling the post -test form after the procedure.

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Düzce General Directorate of Public Health Cancer Early Diagnosis Screening and Training Center

Düzce, Merkez, 81010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hacer GÜLEN SAVAŞ, PhD

  Duzce University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hacer GÜLEN SAVAŞ, PhD

CONTACT

0850 800 81 81; hacergulen@duzce.edu.tr

Ruken Seven, MSc

CONTACT

5459589076; sevenruken@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There are two groups in the study and the informed consent texts of these groups are different. In this way, the participants will not know which group they belong to. The randomization table of the study was made by an independent researcher, so the researcher would not know which patient was in which group. At the end of the research, data analysis will be done by an independent statistician, and the statistician will not know which patient's data belongs to which group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: In the study, there are two groups, the virtual reality group in which virtual reality glasses were applied and the control group, which did not apply any intervention.

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: June 8, 2023
• Study Start: December 12, 2022
• Primary Completion: October 17, 2023
• Study Completion: January 1, 2024
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)