The Effect of Virtual Reality on Women Undergoing Hysterosalpingography

NCT ID: NCT05313373

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality Group

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NESLİHAN YILMAZ SEZER

OTHER

Sponsor Role: lead

Responsible Party

NESLİHAN YILMAZ SEZER

Faculty of Nursing

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ankara University Fertility Diagnosis, Treatment, Research and Application Center

Ankara, Mamak, Turkey (Türkiye)

Ankara University Fertility Diagnosis, Treatment, Research and Application Center

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

04/49

Identifier Type: -

Identifier Source: org_study_id