Clinical trial NCT05313373: The Effect of Virtual Reality on Women Undergoing Hysterosalpingography
Official title: The Effect of Virtual Reality On Women's Perceptıons of Fear, Pain, Anxiety and Satisfaction Undergoing Hysterosalpingography; A Randomized Controlled Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterosalpingography
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in anxiety
timeFrame: immediately before the HSG procedure and immediately after the HSG procedure
measure: Change in the degree of pain experienced during the procedure
timeFrame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
measure: Change in fear
timeFrame: immediately before the HSG procedure, immediately after the HSG procedure, and 15 minutes after the HSG procedure
Secondary outcomes:
measure: the degree of satisfaction
timeFrame: 15 minutes after the HSG procedure
measure: Change in blood pressure
timeFrame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
measure: Change in heart rate
timeFrame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
measure: Change in body temperature
timeFrame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
measure: Change in the saturation of peripheral oxygen SpO2
timeFrame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
measure: HSG result
timeFrame: 15 minutes after the HSG procedure
measure: contrast medium volume
timeFrame: during HSG prosedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Fertility Diagnosis, Treatment, Research and Application Center
state: Mamak
city: Ankara
country: Turkey
facility: Ankara University Fertility Diagnosis, Treatment, Research and Application Center
Study officials:
References: