MidwiferyNCT05641467
Effect of Virtual Reality Glasses Use During Episiotomy Repair Related
A study testing virtual reality glasses in people with Midwifery and Labor Delivery, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
H1-1: Watching video with virtual reality glasses during episiotomy repair reduces the level of pain. H1-2 Watching video with virtual reality glasses during episiotomy repair reduces the level of anxiety. H1-3: Watching video with virtual reality glasses during episiotomy repair increases the level of satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Midwifery, Labor Delivery
- What is being tested?
- virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 24 Dec 2023
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years and over,
- Able to speak Turkish and express himself in Turkish,
- There is no visual or hearing impairment,
- Being open to communication, spiritually and mentally healthy,
- 37- 42 weeks of gestation
- Single pregnancy,
Show all 13Show fewer
- Primiparity,
- Vaginal delivery,
- Vertexpresentation
- Media lateral episiotomy,
- Uncomplicated newborn
- Newborns between 2500 and 4000 g.
- Those with episiotomy between 4-8 cm
Who cannot join
- Presence of obstetric or non-obstetric complications,
- Presence of bleeding requiring urgent measures,
- Administration of sedative drugs before and during episiotomy repair, spinal anesthesia, epidural anesthesia, pudendal block (except for local infiltration of the perineum),
- Lacerations other than episiotomy (anal sphincter injury or Grade 3 or 4 tear),
- Instrument delivery (with vacuum or forceps),
- Postpartum complications in newborns,
- Chronic disease (diabetes mellitus, thyroid disease and hypertension),
- Having a psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Watchıng Vıdeo Wıth Vırtual Realıty Glasses On Paın, Anxıety And Satısfactıon Durıng Epızıotomy Repaır
H1-1: Watching video with virtual reality glasses during episiotomy repair reduces the level of pain.
H1-2 Watching video with virtual reality glasses during episiotomy repair reduces the level of anxiety.
H1-3: Watching video with virtual reality glasses during episiotomy repair increases the level of satisfaction.
- Conditions
- Midwifery, Labor Delivery
- Being tested
- virtual reality glasses
- Keywords
- episiotomy, Virtual Reality, pain, satisfaction, anxiety
- Medical subject headings
- Pain, Personal Satisfaction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesOther
Also called Video will be watched with virtual reality glasses during episiotomy repair
OculusQuest 2 128GB brand virtual reality glasses will be used in our research. OculusQuest 2 128GB is the original all-in-one gaming system for virtual reality. It can only be used as desired with the VR headset and controllers. It adapts to its environment. In this way, it can be played standing and sitting in small and large areas. When glasses will be used on another pregnant women within the scope of COVID-19 measures, disinfection will be provided with 'DiverseyOxivir Plus (hydrogen peroxide)' surface disinfectant. Before the episiotomy repair, the video glasses will be opened, the video will be adjusted to suit the woman. In order for the repair method to be the same for all women, It will be planned to use absorbable, synthetic, braided, sterile surgical thread produced from 1-0 polyglactin.
| Study group | Role | What they receive |
|---|---|---|
| Video will be watched with virtual reality glasses during episiotomy repair | Experimental | Views of nature with virtual reality glasses during episiotomy repair. Receives: Other: virtual reality glasses |
| Control | No intervention | It will be perform routine practice who the women in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-Demographic Data Collection Form
Pregnant Introductory Information Form is a questionnaire prepared by researchers using the literature.
Measured: in active phase on labor (4 cm vaginal dilatation)
State-Trait Anxiety Inventory (STAI)-Questionnaire
State-Trait Anxiety Inventory (STAI)-Questionnaire [ Time Frame: up to one hour ] STAI was used to measure the anxiety level of pregnant women. It was developed by Spielberger et al. (Spielberger et al., 1970) and Öner and Le Compte conducted a Turkish validity and reliability study of the scale (Öner \& LeCompte, 1983). In the scale, individuals are provided to express their feelings with 40 expressions. With the state anxiety scale, it is possible to determine how the individual feels at the moment and in the conditions, and with the trait anxiety scale, how he feels outside of the current situation and conditions. The scale is a 4-point Likert type.The last score obtained shows the anxiety level of the individual. High scores from the scale indicate an increased level of anxiety, low scores indicate a decrease.
Measured: immediately before repair episiotomy
Visual Analog Scale-Pain (VAS-P)
The VAS-P, which is used to evaluate the severity of pain, is a 10 cm long horizontally or vertically drawn ruler, starting with "No pain (0)" and ending with "Unbearable pain (10)". The woman is asked to show the point on this line that corresponds to the intensity of pain she feels. The distance between the marked point and the starting end of the line (0=no pain) is measured in centimeters and the numerical value found shows the severity of the patient's pain (Hayes and Patterson 1921). VAS-P is accepted as a safe, valid and usable measurement tool in repeated measurements. In this study, horizontally prepared VAS-P was used to assess pain intensity.
Measured: immediately before repair episiotomy
Secondary outcomes (4)
State-Trait Anxiety Inventory (STAI)-Questionnaire
State-Trait Anxiety Inventory (STAI)-Questionnaire [ Time Frame: up to one hour ]
Measured: immediately after episiotomy repair
Visual Analog Scale-Pain (VAS-P)
The VAS-P, which is used to evaluate the severity of pain, is a 10 cm long horizontally or vertically drawn ruler, starting with "No pain (0)" and ending with "Unbearable pain (10)". The woman is asked to show the point on this line that corresponds to the intensity of pain she feels. The distance between the marked point and the starting end of the line (0=no pain) is measured in centimeters and the numerical value found shows the severity of the patient's pain (Hayes and Patterson 1921). VAS-P is accepted as a safe, valid and usable measurement tool in repeated measurements. In this study, horizontally prepared VAS-P was used to assess pain intensity.
Measured: immediately after episiotomy repair
Birth Action Follow-up Form
This form includes the week of pregnancy, the height and weight of the pregnant woman, hemoglobin values, induction status, how long the birth stages last, the time of opening the episiotomy, the time of starting the repair, the ending time of the repair, the length of the episiotomy, the baby's Apgar score, the baby's weight.
Measured: 60 minutes after birth
Satisfaction Evaluation Scale and Form
"Visual Analog Scale (VAS)" has been adapted to similar usage principles. The VAS is a scale that is evaluated by individuals on a horizontal or vertical line of 10 cm or 100 mm, with one end indicating that the individual is "very good" and the other end is "very bad".
Measured: immediately after episiotomy repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start6 Jun 2022
- Primary completion24 Dec 2023
- Study completion24 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MidwiferyStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sample size G-power 3.1.9.7. program (Faul et al 2007, Faul et al 2009). Shourab et al. anxiety score average in the study; It was found to be 24.9±1.9 in the intervention group and 21.2±1.1 in the control group. In the light of this study, 0.897 effect size, 0.95 power, 0.05 alpha level and bidirectional hypothesis options were selected in the program, and the number of participants for each group was 34 (Shourab et al 2016). The pregnant women who came to the hospital will evaluate in terms of sample criteria and randomized sampling will divide into two groups. In order to ensure randomization in the study, a random numbers table was created by dividing them into two groups over the number determined on the site https://www.random.org/. Pregnant women will be assigned to groups according to the randomization scheme. Considering that there may be data loss, 20% more was determined and it was planned to study with 82 (41 intervention, 41 control) pregnant women.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rüveyde CAN, Selcuk University
- Investigators
- Rüveyde Can, Principal investigator, Necmettin Erbakan University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641467
- Sponsor's protocol ID
- 0000-0002-1344-0908
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2022
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Watchıng Vıdeo Wıth Vırtual Realıty Glasses On Paın, Anxıety And Satısfactıon Durıng Epızıotomy Repaır
- ClinicalTrials.gov ID
- NCT05641467
- Acronym / sponsor ID
- 0000-0002-1344-0908
- Conditions
- Midwifery, Labor Delivery
- Keywords
- episiotomy, Virtual Reality, pain, satisfaction, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 24 Dec 2023 (actual)
- Study completion
- 24 Dec 2023 (actual)
- First posted
- 7 Dec 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.
H1-1: Watching video with virtual reality glasses during episiotomy repair reduces the level of pain.
H1-2 Watching video with virtual reality glasses during episiotomy repair reduces the level of anxiety.
H1-3: Watching video with virtual reality glasses during episiotomy repair increases the level of satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Sample size G-power 3.1.9.7. program (Faul et al 2007, Faul et al 2009). Shourab et al. anxiety score average in the study; It was found to be 24.9±1.9 in the intervention group and 21.2±1.1 in the control group. In the light of this study, 0.897 effect size, 0.95 power, 0.05 alpha level and bidirectional hypothesis options were selected in the program, and the number of participants for each group was 34 (Shourab et al 2016). The pregnant women who came to the hospital will evaluate in terms of sample criteria and randomized sampling will divide into two groups. In order to ensure randomization in the study, a random numbers table was created by dividing them into two groups over the number determined on the site https://www.random.org/. Pregnant women will be assigned to groups according to the randomization scheme. Considering that there may be data loss, 20% more was determined and it was planned to study with 82 (41 intervention, 41 control) pregnant women.
| Arm | Type | Receives |
|---|---|---|
| Video will be watched with virtual reality glasses during episiotomy repair | Experimental | Other: virtual reality glassesViews of nature with virtual reality glasses during episiotomy repair. |
| Control | No intervention | –It will be perform routine practice who the women in the control group. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 18 years and over,
Key exclusion criteria (8 listed)
- Presence of obstetric or non-obstetric complications,
- Presence of bleeding requiring urgent measures,
- Administration of sedative drugs before and during episiotomy repair, spinal anesthesia, epidural anesthesia, pudendal block (except for local infiltration of the perineum),
- Lacerations other than episiotomy (anal sphincter injury or Grade 3 or 4 tear),
- Instrument delivery (with vacuum or forceps),
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 glassesAlso: Video will be watched with virtual reality glasses during episiotomy repairOculusQuest 2 128GB brand virtual reality glasses will be used in our research. OculusQuest 2 128GB is the original all-in-one gaming system for virtual reality. It can only be used as desired with the VR headset and controllers. It adapts to its environment. In this way, it can be played standing and sitting in small and large areas. When glasses will be used on another pregnant women within the scope of COVID-19 measures, disinfection will be provided with 'DiverseyOxivir Plus (hydrogen peroxide)' surface disinfectant. Before the episiotomy repair, the video glasses will be opened, the video will be adjusted to suit the woman. In order for the repair method to be the same for all women, It will be planned to use absorbable, synthetic, braided, sterile surgical thread produced from 1-0 polyglactin. | Other | Video will be watched with virtual reality glasses during episiotomy repair |
Primary outcome
Socio-Demographic Data Collection Form
Time frame: in active phase on labor (4 cm vaginal dilatation)
Pregnant Introductory Information Form is a questionnaire prepared by researchers using the literature.
State-Trait Anxiety Inventory (STAI)-Questionnaire
Time frame: immediately before repair episiotomy
State-Trait Anxiety Inventory (STAI)-Questionnaire [ Time Frame: up to one hour ] STAI was used to measure the anxiety level of pregnant women. It was developed by Spielberger et al. (Spielberger et al., 1970) and Öner and Le Compte conducted a Turkish validity and reliability study of the scale (Öner \& LeCompte, 1983). In the scale, individuals are provided to express their feelings with 40 expressions. With the state anxiety scale, it is possible to determine how the individual feels at the moment and in the conditions, and with the trait anxiety scale, how he feels outside of the current situation and conditions. The scale is a 4-point Likert type.The last score obtained shows the anxiety level of the individual. High scores from the scale indicate an increased level of anxiety, low scores indicate a decrease.
Visual Analog Scale-Pain (VAS-P)
Time frame: immediately before repair episiotomy
The VAS-P, which is used to evaluate the severity of pain, is a 10 cm long horizontally or vertically drawn ruler, starting with "No pain (0)" and ending with "Unbearable pain (10)". The woman is asked to show the point on this line that corresponds to the intensity of pain she feels. The distance between the marked point and the starting end of the line (0=no pain) is measured in centimeters and the numerical value found shows the severity of the patient's pain (Hayes and Patterson 1921). VAS-P is accepted as a safe, valid and usable measurement tool in repeated measurements. In this study, horizontally prepared VAS-P was used to assess pain intensity.
4 secondary outcomes
State-Trait Anxiety Inventory (STAI)-Questionnaire
Time frame: immediately after episiotomy repair
Visual Analog Scale-Pain (VAS-P)
Time frame: immediately after episiotomy repair
Birth Action Follow-up Form
Time frame: 60 minutes after birth
Satisfaction Evaluation Scale and Form
Time frame: immediately after episiotomy repair
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 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Rüveyde Can principal investigator
Necmettin Erbakan University, Faculty of Medicine
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 in people with Midwifery and Labor Delivery, run by Selcuk 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 13 inclusion and 8 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 Nov 2024. 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?
Socio-Demographic Data Collection Form (time frame: in active phase on labor (4 cm vaginal dilatation)). 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 Nov 2024.