The Effect of Virtual Reality on Women Undergoing Hysterosalpingography

NCT05313373 | Completed

• 1 other identifier: 04/49
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hysterosalpingography

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• the degree of satisfaction

  15 minutes after the HSG procedure

• Change in blood pressure

  immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure

• Change in heart rate

  immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure

• Change in body temperature

  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

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Other: Virtual Reality

Control Group

NO INTERVENTION

Interventions

Virtual Reality OTHER

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.

Virtual Reality Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NESLİHAN YILMAZ SEZER: lead

Study Sites (2)

Ankara University Fertility Diagnosis, Treatment, Research and Application Center

Ankara, Mamak, 06100, Turkey (Türkiye)

Location

Ankara University Fertility Diagnosis, Treatment, Research and Application Center

Ankara, 06100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty of Nursing

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 6, 2022
• Study Start: April 26, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

TU (2)