InfertilityNCT05192330
Intrauterine Insemination and Nursing
A study testing Virtual Reality Glasses and Therapeutic Touch in people with Infertility, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effect of virtual reality glasses use and therapeutic touch on pain, anxiety and patient satisfaction in women during intrauterine insemination procedure 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
- Infertility
- What is being tested?
- Virtual Reality Glasses and Therapeutic Touch
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2022to 1 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being diagnosed with infertility over 18 years, being able to understand, read and write in Turkish, wanting to participate in the study,
Who cannot join
- not wanting to be included in the study not accepting Therapeutic Touch or Virtual reality glasses not knowing Turkish not wanting to be included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55200
About this study
Official title: The Effect of Virtual Reality Glasses Use and Therapeutic Touch on Pain, Anxiety and Patient Satisfaction in Women During Intrauterine Insemination Procedure: A Randomized Controlled Study
This study investigates the effect of virtual reality glasses use and therapeutic touch on pain, anxiety and patient satisfaction in women during intrauterine insemination procedure
Read the detailed description
Infertility treatment is a stressful and anxious process that begins when couples are diagnosed with infertility. Infertility treatment is a process that requires the active participation of couples against emotional and physical difficulties. In addition to intensive routine and surgical procedures, the treatment process is a period in which couples should be in constant communication with healthcare professionals. In Turkey, it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation of infertile couples,Intrauterine Insemination is a simple, safe, and minimally invasive procedure to the process of injecting washed sperm into the uterine cavity close to ovulation. Sperm cells taken from men are injected directly into the uterus and left at a point closer to the fertilization point. The aim of this study is to investigate the effect of virtual reality glasses use and therapeutic touch on pain, anxiety and patient satisfaction in women during intrauterine insemination procedure.
This randomized controlled study will conduct at Ondokuz Mayis University Training and Research Hospital, Infertility polyclinic between january 2022 and June 2022.
Volunteer women undergoing Intrauterine Insemination will be include. Participants will randomly assigned to the 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, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores will use for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale (pain and nursing satisfaction) were applied to both groups by face to face interview during the day giving appointment for Intrauterine Insemination. Immediately after the questionnaires will apply, the nurse gave virtual reality glasses. and glasses will be put on before the process starts and training will be given to continue watching the video while wearing the glasses for 30 minutes. Second group participants the nurse researcher will start the application by taking an appropriate hand of the patient between his hands and hold it for 30 minutes.
Participant in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (virtual reality or therapeutic touch) was performed.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program was used to evaluate the data obtained in the study.
- Conditions
- Infertility
- Being tested
- Virtual Reality Glasses, Therapeutic Touch
- Keywords
- intrauterine insemination, nursing, pain, anxiety
- Medical subject headings
- Infertility, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesDevice
After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale (pain) were applied to both groups by face to face interview during the day giving appointment for intrauterine insemination. Immediately after the questionnaires were answered, virtual reality glasses were given by the nurse researcher to intervention group for 30 minutes.
Therapeutic TouchBehavioural
After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS (pain) scoring scale were applied to both groups by face to face interview during the day giving appointment for intrauterine insemination. Immediately after the questionnaires were answered, therapeutictouch were given by the nurse researcher to intervention group for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses | Experimental | After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale(pain and nursing satisfaction) scoring scale will apply to both groups by face to face interview during the day giving appointment for intrauterine insemination. Immediately after the questionnaires were applied, the nurse gave Virtual Reality Glasses for 30 minutes.
Glasses will be given put on before the process starts and training will be given to continue watching the video while wearing the glasses.The women include in the Virtual reality application group will be shown a video with a nature view during the procedure.
Every woman will be shown the same video. Receives: Device: Virtual Reality Glasses |
| Therapeutic Touch | Experimental | Applied therapeutic touch intervention on their hands for 30 minutes to help patients feel comfortable during the procedure.The researcher started the application by taking an appropriate hand of the patient between his hands and held it for 30 minutes. The researcher's fingers are closed, not clasped, and his hand is placed on the participant's hand.
The researcher held her hand steady without touching or rubbing it. In addition, the researcher is not use gloves. Receives: Behavioral: Therapeutic Touch |
| 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 (virtual reality or Therapeutic Touch) was performed. Both groups were re-evaluated using the same scales after the intrauterine insemination. Within 5 minutes of completing the procedure, participants will asked to evaluate their pain in order to characterize pain intensity using the visual analogue scale, anxiety scale and satisfaction scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberger State Anxiety Scale
After completing the Intrauterine Insemination Procedure, participants filled out the 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.
Measured: 30 minutes
Visual Analog Scale for pain intensity
After completing the Intrauterine Insemination Procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS).
A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.
Measured: 10 minutes
Visual Analog Scale for patient satifaction
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 minutess
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 start24 Jan 2022
- Primary completion1 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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 will conduct at Ondokuz Mayis University Training and Research Hospital, Obstetrics and Gynecology polyclinic between January 2022 and June 2022. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye BAL, Ondokuz Mayıs University
- Investigators
- Emine KOÇ, Asst.Prof, Study chair, Ondokuz Mayıs UniversityNeşe KARAKAYA, lecturer, Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192330
- Sponsor's protocol ID
- 2021/350
- Status last verified
- Oct 2023
- First submitted
- 12 Jan 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nazarinasab, M., Motamedfar, A., Najafian, M., & Tabibi, H. (2018). Investigating the effects of relaxation therapy on decreasing anxiety in patients with elective caesarean section in Imam Khomeini Hospital, Ahvaz, Iran during 2016. Medical Studies/Studia Medyczne, 34(2), 107-111.
Bal S, Karakaya N, Koc E, Guven D. The effect of virtual reality (VR) glasses and therapeutic touch (TT) on pain, anxiety, and patient satisfaction during intrauterine insemination (IUI) compared to standard care: a single-blind, randomized controlled trial. BMC Pregnancy Childbirth. 2025 Mar 27;25(1):361. doi: 10.1186/s12884-025-07435-0.
PubMed 40148795
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Use and Therapeutic Touch on Pain, Anxiety and Patient Satisfaction in Women During Intrauterine Insemination Procedure: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05192330
- Acronym / sponsor ID
- 2021/350
- Conditions
- Infertility
- Keywords
- intrauterine insemination, nursing, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 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.
This study investigates the effect of virtual reality glasses use and therapeutic touch on pain, anxiety and patient satisfaction in women during intrauterine insemination procedure
Detailed description
Infertility treatment is a stressful and anxious process that begins when couples are diagnosed with infertility. Infertility treatment is a process that requires the active participation of couples against emotional and physical difficulties. In addition to intensive routine and surgical procedures, the treatment process is a period in which couples should be in constant communication with healthcare professionals. In Turkey, it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation of infertile couples,Intrauterine Insemination is a simple, safe, and minimally invasive procedure to the process of injecting washed sperm into the uterine cavity close to ovulation. Sperm cells taken from men are injected directly into the uterus and left at a point closer to the fertilization point. The aim of this study is to investigate the effect of virtual reality glasses use and therapeutic touch on pain, anxiety and patient satisfaction in women during intrauterine insemination procedure.
This randomized controlled study will conduct at Ondokuz Mayis University Training and Research Hospital, Infertility polyclinic between january 2022 and June 2022.
Volunteer women undergoing Intrauterine Insemination will be include. Participants will randomly assigned to the 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, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores will use for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale (pain and nursing satisfaction) were applied to both groups by face to face interview during the day giving appointment for Intrauterine Insemination. Immediately after the questionnaires will apply, the nurse gave virtual reality glasses. and glasses will be put on before the process starts and training will be given to continue watching the video while wearing the glasses for 30 minutes. Second group participants the nurse researcher will start the application by taking an appropriate hand of the patient between his hands and hold it for 30 minutes.
Participant in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (virtual reality or therapeutic touch) was performed.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program was used to evaluate the data obtained in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This randomized controlled study will conduct at Ondokuz Mayis University Training and Research Hospital, Obstetrics and Gynecology polyclinic between January 2022 and June 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 Glasses | Experimental | Device: Virtual Reality GlassesAfter obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale(pain and nursing satisfaction) scoring scale will apply to both groups by face to face interview during the day giving appointment for intrauterine insemination. Immediately after the questionnaires were applied, the nurse gave Virtual Reality Glasses for 30 minutes. Glasses will be given put on before the process starts and training will be given to continue watching the video while wearing the glasses.The women include in the Virtual reality application group will be shown a video with a nature view during the procedure. Every woman will be shown the same video. |
| Therapeutic Touch | Experimental | Behavioral: Therapeutic TouchApplied therapeutic touch intervention on their hands for 30 minutes to help patients feel comfortable during the procedure.The researcher started the application by taking an appropriate hand of the patient between his hands and held it for 30 minutes. The researcher's fingers are closed, not clasped, and his hand is placed on the participant's hand. The researcher held her hand steady without touching or rubbing it. In addition, the researcher is not use gloves. |
| 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 (virtual reality or Therapeutic Touch) was performed. Both groups were re-evaluated using the same scales after the intrauterine insemination. Within 5 minutes of completing the procedure, participants will asked to evaluate their pain in order to characterize pain intensity using the visual analogue scale, anxiety scale and satisfaction scale. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- being diagnosed with infertility over 18 years, being able to understand, read and write in Turkish, wanting to participate in the study,
Key exclusion criteria (1 listed)
- not wanting to be included in the study not accepting Therapeutic Touch or Virtual reality glasses not knowing Turkish not wanting to be included in the study
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 GlassesAfter obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale (pain) were applied to both groups by face to face interview during the day giving appointment for intrauterine insemination. Immediately after the questionnaires were answered, virtual reality glasses were given by the nurse researcher to intervention group for 30 minutes. | Device | Virtual Reality Glasses |
| Therapeutic TouchAfter obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS (pain) scoring scale were applied to both groups by face to face interview during the day giving appointment for intrauterine insemination. Immediately after the questionnaires were answered, therapeutictouch were given by the nurse researcher to intervention group for 30 minutes. | Behavioural | Therapeutic Touch |
Primary outcome
Spielberger State Anxiety Scale
Time frame: 30 minutes
After completing the Intrauterine Insemination Procedure, participants filled out the 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.
Visual Analog Scale for pain intensity
Time frame: 10 minutes
After completing the Intrauterine Insemination Procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS). A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.
Visual Analog Scale for patient satifaction
Time frame: 10 minutess
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.
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 10 Oct 2023.
- BackgroundNazarinasab, M., Motamedfar, A., Najafian, M., & Tabibi, H. (2018). Investigating the effects of relaxation therapy on decreasing anxiety in patients with elective caesarean section in Imam Khomeini Hospital, Ahvaz, Iran during 2016. Medical Studies/Studia Medyczne, 34(2), 107-111.
- Derived from this study: PubMed 40148795Bal S, Karakaya N, Koc E, Guven D. The effect of virtual reality (VR) glasses and therapeutic touch (TT) on pain, anxiety, and patient satisfaction during intrauterine insemination (IUI) compared to standard care: a single-blind, randomized controlled trial. BMC Pregnancy Childbirth. 2025 Mar 27;25(1):361. doi: 10.1186/s12884-025-07435-0.
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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
Neşe KARAKAYA, 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 Glasses and Therapeutic Touch in people with Infertility, run by Ondokuz Mayıs University 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 1 inclusion and 1 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 10 Oct 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 NCT05192330, which also lists 2 linked publications.
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 10 Oct 2023.