HysterosalpingographyNCT05313373
The Effect of Virtual Reality on Women Undergoing Hysterosalpingography
A study testing Virtual Reality in people with Hysterosalpingography, run by NESLİHAN YILMAZ SEZER at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterosalpingography
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 26 Apr 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara University Fertility Diagnosis, Treatment, Research and Application Center
Ankara, Mamak, 06100
Ankara University Fertility Diagnosis, Treatment, Research and Application Center
Ankara, 06100
About this study
Official title: 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.
Read more
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
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Not described Receives: Other: Virtual Reality |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: immediately before the HSG procedure, immediately after the HSG procedure, and 15 minutes after the HSG procedure
Secondary outcomes (7)
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.
Measured: 15 minutes after the HSG procedure
Change in blood pressure
mmHg
Measured: 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)
Measured: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
Change in body temperature
degrees Celsius
Measured: 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
Measured: 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
Measured: 15 minutes after the HSG procedure
contrast medium volume
milliliter (ml)
Measured: during HSG prosedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start26 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterosalpingographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- NESLİHAN YILMAZ SEZER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NESLİHAN YILMAZ SEZER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313373
- Sponsor's protocol ID
- 04/49
- Status last verified
- Jan 2023
- First submitted
- 14 Mar 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality On Women's Perceptıons of Fear, Pain, Anxiety and Satisfaction Undergoing Hysterosalpingography; A Randomized Controlled Research
- ClinicalTrials.gov ID
- NCT05313373
- Acronym / sponsor ID
- 04/49
- Conditions
- Hysterosalpingography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- NESLİHAN YILMAZ SEZERUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual Reality |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityIn 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. | Other | Virtual Reality Group |
Primary outcome
Change in anxiety
Time frame: immediately before the HSG procedure and immediately after the HSG procedure
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.
Change in the degree of pain experienced during the procedure
Time frame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG 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
Change in fear
Time frame: immediately before the HSG procedure, immediately after the HSG procedure, and 15 minutes after the HSG procedure
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.
7 secondary outcomes
the degree of satisfaction
Time frame: 15 minutes after the HSG procedure
Change in blood pressure
Time frame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
Change in heart rate
Time frame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
Change in body temperature
Time frame: 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
Time frame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure
HSG result
Time frame: 15 minutes after the HSG procedure
contrast medium volume
Time frame: during HSG prosedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Hysterosalpingography, run by NESLİHAN YILMAZ SEZER at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety (time frame: immediately before the HSG procedure and immediately after the HSG procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.