Women's HealthNCT05192343
Effects of Virtual Reality and Nature Sounds on Pain and Anxiety During Hysterosalpingography
A study testing Virtual Reality and nature sounds and nature sounds in people with Women's Health, run by Sümeyye BAL at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to demonstrate the effects of virtual reality and nature sounds on pain and anxiety during hysterosalpingography. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health
- What is being tested?
- Virtual Reality and nature sounds and nature sounds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2022to 15 Aug 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Wanting to participate in the study,
- being literate,
- over 18 years,
- at least primary school graduate,
- without a diagnosed psychiatric illness,
- not have mental insufficiency and communication problems,
- have no hearing problems,
- without drug sensitivity and allergy,
Who cannot join
- illiterate,
- with a diagnosed psychiatric illness,
- mental deficiency and communication problems,
- under 18 years old,
- who did not want to participate in the research,
- having hearing problems
- drug sensitivity and allergy,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55200
About this study
Official title: Effects of Virtual Reality and Nature Sounds on Pain and Anxiety During Hysterosalpingography: Randomized Controlled Study
The aim of this study is to demonstrate the effects of virtual reality and nature sounds on pain and anxiety during hysterosalpingography.
Read the detailed description
Infertility treatment is a stressful and anxious process that begins when couples are diagnosed with infertility. Although this process may seem like a simple medical intervention, the treatment stages affect the couple in many ways when it is deepened. Infertility treatment is a process that requires the active participation of couples against emotional and physical difficulties. The treatment process is a period in which couples should be in constant communication with healthcare professionals, as well as intensive routine and surgical procedures.In this process, medical and surgical treatment methods are used. In the literature, it is stated that 85-90% of the problems that cause infertility are solved with medical and surgical treatment. In the evaluation of infertile couples, hysterosalpingography (HSG) is a invasive radiologic procedure to visualize uterine cavity and tubes after contrast enhancement. HSG plays an important diagnostic role in finding the cause of infertility and in deciding the line of management.The aim of this study is to demonstrate the effects of virtual reality and nature sounds on pain and anxiety during hysterosalpingography. This randomized controlled study will conduct at Ondokuz Mayıs University Training and Research Hospital, Obstetrics and Gynecology polyclinic between February 2022 and August 2022. Volunteer women undergoing HSG as part of infertility evaluation will be includ. Participants will randomly assigned to the Virtual Reality and nature sounds intervention, nature sounds intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, place to live, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale for pain and Visual Analog Scales for satisfaction will use for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS pain scoring scale will be applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were applied, the nurse gave virtual reality glasses and headphone to intervention group for before HSG and while HSG totally 30 minutes. The nurse gave to nature sounds intervention group headphone. After the groups will formed, a nature-based sound will listen to the women in the nature sounds group before and during the HSG procedure. Listening to nature-based sound will perform for a total of 15 minutes half an hour before the HSG procedure, and for 15 minutes during the procedure, for a total of 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (nature sounds or virtual reality) will perform.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program will use to evaluate the data obtained in the study.
- Conditions
- Women's Health
- Being tested
- Virtual Reality and nature sounds, nature sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality and nature soundsDevice
After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale for pain were applied to both groups by face to face interview during the day giving appointment for HSG. Before and during the HSG shooting, the virtual reality and nature sounds application group watched a video with a nature view with virtual reality glasses and listening nature sounds.
Glasses were introduced before the procedure. Before the procedure started, glasses were put on and training was given to continue watching the video by wearing glasses during the procedure.
The women include in the virtual reality and nature sounds application group will make to watch a video with a nature view with nature sounds for 15 minutes before and during the HSG procedure.
Each woman was shown the same video.
nature soundsOther
After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale for pain were applied to both groups by face to face interview during the day giving appointment for HSG. Before the procedure started, glasses will put on and training was given to continue. After the groups were formed, a nature-based sound was played to the women in the nature sounds group before and during the HSG shooting.
Listening to nature-based sound will perform for a total of 15 minutes half an hour before the HSG procedure, and for 15 minutes during the procedure, for a total of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality and nature sounds | Experimental | After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale for pain will apply to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires will apply, before and during the HSG procedure, the Virtual Reality and nature sounds application group watch a video with a nature view with virtual reality glasses.Glasses will introduce before the procedure. Before the procedure started, glasses will put on and training will given to continue watching the video by wearing glasses during the procedure. The women will be included in the Virtual Reality and nature sounds intervention group will make to watch a video with a nature view for 15 minutes and listening nature sounds before and during the HSG procedure. Each woman was shown the same video. Receives: Device: Virtual Reality and nature sounds |
| nature sounds | Experimental | After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale for pain will apply to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires will apply, a nature-based sound will play to the women in the nature sounds group before and during the HSG shooting.Listening to nature-based sound will perform for a total of 15 minutes half an hour before the HSG procedure, and for 15 minutes during the procedure, for a total of 30 minutes. Receives: Other: nature sounds |
| control group | No intervention | Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention will perform. Both groups will re-evaluated using the same scales after the hysterosalpingography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberger State Anxiety Scale
The inventory was developed by Spielberger, Gorsuch, and Lushene in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety. The Cronbach's a for the STAI ranges from 0.83 to 0.87
Measured: 30 minutes
Visual Analog Scale For Satisfaction
Visual Analog Scale Satisfaction level was measured using the visual analog scale (VAS). VAS is used to convert some numerically unmeasured values to numeric values. VAS is a continuous scale that comprises a horizontal line or a vertical line, usually 10 cm (100 mm) in length. On one end of the scale is the statement, "I am not satisfied at all" (zero points), whereas the statement at the other end is "very satisfied." Patients were asked to mark their satisfaction levels on this scale of 100 mm.
Measured: 10 minutes
Visual Analog Scale for pain
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: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start7 Feb 2022
- Primary completion25 Apr 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Women's HealthStudies 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
- Model description
- This randomized controlled study was conducted at Ondokuz Mayis University Training and Research Hospital, Obstetrics and Gynecology polyclinic between February 2022 and August 2022. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sümeyye BAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümeyye BAL, Ondokuz Mayıs University
- Investigators
- Emine KOÇ, Asst.Prof, Study chair, Ondokuz Mayıs UniversityNazlı BALTACI, Asst.Prof, Study director, Ondokuz Mayıs UniversityElif KETEN EDİS, Lecturer, Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192343
- Sponsor's protocol ID
- 2021/435
- Status last verified
- Sep 2023
- First submitted
- 12 Jan 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agwu, K. K., & Okoye, I. J. (2007). The effect of music on the anxiety levels of patients undergoing hysterosalpingography. Radiography, 13(2), 122-125.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality and Nature Sounds on Pain and Anxiety During Hysterosalpingography: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05192343
- Acronym / sponsor ID
- 2021/435
- Conditions
- Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Sümeyye BALUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 14 Jan 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 demonstrate the effects of virtual reality and nature sounds on pain and anxiety during hysterosalpingography.
Detailed description
Infertility treatment is a stressful and anxious process that begins when couples are diagnosed with infertility. Although this process may seem like a simple medical intervention, the treatment stages affect the couple in many ways when it is deepened. Infertility treatment is a process that requires the active participation of couples against emotional and physical difficulties. The treatment process is a period in which couples should be in constant communication with healthcare professionals, as well as intensive routine and surgical procedures.In this process, medical and surgical treatment methods are used. In the literature, it is stated that 85-90% of the problems that cause infertility are solved with medical and surgical treatment. In the evaluation of infertile couples, hysterosalpingography (HSG) is a invasive radiologic procedure to visualize uterine cavity and tubes after contrast enhancement. HSG plays an important diagnostic role in finding the cause of infertility and in deciding the line of management.The aim of this study is to demonstrate the effects of virtual reality and nature sounds on pain and anxiety during hysterosalpingography. This randomized controlled study will conduct at Ondokuz Mayıs University Training and Research Hospital, Obstetrics and Gynecology polyclinic between February 2022 and August 2022. Volunteer women undergoing HSG as part of infertility evaluation will be includ. Participants will randomly assigned to the Virtual Reality and nature sounds intervention, nature sounds intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, place to live, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale for pain and Visual Analog Scales for satisfaction will use for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS pain scoring scale will be applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were applied, the nurse gave virtual reality glasses and headphone to intervention group for before HSG and while HSG totally 30 minutes. The nurse gave to nature sounds intervention group headphone. After the groups will formed, a nature-based sound will listen to the women in the nature sounds group before and during the HSG procedure. Listening to nature-based sound will perform for a total of 15 minutes half an hour before the HSG procedure, and for 15 minutes during the procedure, for a total of 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (nature sounds or virtual reality) will perform.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program will use to evaluate the data obtained in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This randomized controlled study was conducted at Ondokuz Mayis University Training and Research Hospital, Obstetrics and Gynecology polyclinic between February 2022 and August 2022. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality and nature sounds | Experimental | Device: Virtual Reality and nature soundsAfter obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale for pain will apply to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires will apply, before and during the HSG procedure, the Virtual Reality and nature sounds application group watch a video with a nature view with virtual reality glasses.Glasses will introduce before the procedure. Before the procedure started, glasses will put on and training will given to continue watching the video by wearing glasses during the procedure. The women will be included in the Virtual Reality and nature sounds intervention group will make to watch a video with a nature view for 15 minutes and listening nature sounds before and during the HSG procedure. Each woman was shown the same video. |
| nature sounds | Experimental | Other: nature soundsAfter obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale for pain will apply to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires will apply, a nature-based sound will play to the women in the nature sounds group before and during the HSG shooting.Listening to nature-based sound will perform for a total of 15 minutes half an hour before the HSG procedure, and for 15 minutes during the procedure, for a total of 30 minutes. |
| control group | No intervention | –Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention will perform. Both groups will re-evaluated using the same scales after the hysterosalpingography. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Wanting to participate in the study,
- being literate,
- over 18 years,
- at least primary school graduate,
- without a diagnosed psychiatric illness,
Key exclusion criteria (7 listed)
- illiterate,
- with a diagnosed psychiatric illness,
- mental deficiency and communication problems,
- under 18 years old,
- who did not want to participate in the research,
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 Reality and nature soundsAfter obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale for pain were applied to both groups by face to face interview during the day giving appointment for HSG. Before and during the HSG shooting, the virtual reality and nature sounds application group watched a video with a nature view with virtual reality glasses and listening nature sounds. Glasses were introduced before the procedure. Before the procedure started, glasses were put on and training was given to continue watching the video by wearing glasses during the procedure. The women include in the virtual reality and nature sounds application group will make to watch a video with a nature view with nature sounds for 15 minutes before and during the HSG procedure. Each woman was shown the same video. | Device | Virtual Reality and nature sounds |
| nature soundsAfter obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale for pain were applied to both groups by face to face interview during the day giving appointment for HSG. Before the procedure started, glasses will put on and training was given to continue. After the groups were formed, a nature-based sound was played to the women in the nature sounds group before and during the HSG shooting. Listening to nature-based sound will perform for a total of 15 minutes half an hour before the HSG procedure, and for 15 minutes during the procedure, for a total of 30 minutes. | Other | nature sounds |
Primary outcome
Spielberger State Anxiety Scale
Time frame: 30 minutes
The inventory was developed by Spielberger, Gorsuch, and Lushene in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety. The Cronbach's a for the STAI ranges from 0.83 to 0.87
Visual Analog Scale For Satisfaction
Time frame: 10 minutes
Visual Analog Scale Satisfaction level was measured using the visual analog scale (VAS). VAS is used to convert some numerically unmeasured values to numeric values. VAS is a continuous scale that comprises a horizontal line or a vertical line, usually 10 cm (100 mm) in length. On one end of the scale is the statement, "I am not satisfied at all" (zero points), whereas the statement at the other end is "very satisfied." Patients were asked to mark their satisfaction levels on this scale of 100 mm.
Visual Analog Scale for pain
Time frame: 10 minutes
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
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 26 Sep 2023.
- BackgroundAgwu, K. K., & Okoye, I. J. (2007). The effect of music on the anxiety levels of patients undergoing hysterosalpingography. Radiography, 13(2), 122-125.
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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.
Emine KOÇ, Asst.Prof study chair
Ondokuz Mayıs University
Nazlı BALTACI, Asst.Prof study director
Ondokuz Mayıs University
Elif KETEN EDİS, Lecturer study chair
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and nature sounds and nature sounds in people with Women's Health, run by Sümeyye BAL at 1 site 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 8 inclusion and 7 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 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Spielberger State Anxiety Scale (time frame: 30 minutes). 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?
On the ClinicalTrials.gov record for NCT05192343, which also lists 1 linked publication.
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 26 Sep 2023.