The Effect of Virtual Reality on Women Undergoing Hysterosalpingography

The Effect of Virtual Reality On Women's Perceptıons of Fear, Pain, Anxiety and Satisfaction Undergoing Hysterosalpingography; A Randomized Controlled Research

The aim of this study is to determine the effect of virtual reality on perceived pain, anxiety, fear, physiological reactions and satisfaction in women during the HSG procedure.

Hypotheses H01; In the HSG procedure, there was no difference between the pain score of the virtual reality group and the pain score of the control group.

H02; In the HSG procedure, there was no difference between the anxiety score of the virtual reality group and the anxiety score of the control group.

H03; In the HSG procedure, there was no difference between the satisfaction score of the virtual reality group and the satisfaction score of the control group.

H04; In the HSG procedure, there was no difference between the vital signs of the virtual reality group and the control group.

H05; In the HSG procedure, there was no difference between the fear score of the virtual reality group and the fear score of the control group.

The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an HSG. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 10 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing music of the video will be played in the practice room with a bluetooth speaker.

Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure.

Study Overview

• Status: Completed
• Conditions: Hysterosalpingography
• Intervention / Treatment: Other: Virtual Reality

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Ankara University Fertility Diagnosis, Treatment, Research and Application Center
  • Mamak
    • Ankara, Mamak, Turkey, 06100
      • Ankara University Fertility Diagnosis, Treatment, Research and Application Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• primary infertility
• Agreeing to participate in the research and obtaining written permission,
• No hearing or vision problems
• The first time HSG procedure will be applied

Exclusion Criteria:

• Didn't watch the whole video
• Those with motion-sensitive diseases such as vertigo, meniere
• Using any pharmacological pain-reducing method within 30 minutes
• Difficulty in the HSG process or completing the process with more than one attempt
• Use of antidepressants or sedatives
• Any history of allergy to radio-opaque dye

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Virtual Reality Group	Other: Virtual Reality; In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 10 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing music of the video will be played.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety	STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.	immediately before the HSG procedure and immediately after the HSG procedure
Change in the degree of pain experienced during the procedure	The pain was assessed using 0-100 mm VAS for determining perceptions of pain during the procedure. This scale is widely used and has demonstrated reliability and validity in the measurement of acute pain. A high score on the scale indicated a high level of pain and a score of 0 pointed to no pain at all (Bijur, Silver, & Gallagher, 2001). Each participant was asked to mark her current level of perceived pain along the scale, with the number corresponding to the marked point recorded as the pain score	immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
Change in fear	VAS is a 10-cm-long measurement tool. The left end of the scale reads "no fear at all" and the right end reads "the most intense fear possible". A high score on the scale indicated a high level of fear and a score of 0 pointed to no fear.	immediately before the HSG procedure, immediately after the HSG procedure, and 15 minutes after the HSG procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the degree of satisfaction	VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.	15 minutes after the HSG procedure
Change in blood pressure	mmHg	immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
Change in heart rate	beats per minute (bpm)	immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
Change in body temperature	degrees Celsius	immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
Change in the saturation of peripheral oxygen SpO2		immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
HSG result	both tubes patent, one fallopian tubes occluded, both fallopian tubes occluded	15 minutes after the HSG procedure
contrast medium volume	milliliter (ml)	during HSG prosedure

Collaborators and Investigators

• Sponsor: NESLİHAN YILMAZ SEZER

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 04/49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No